chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Initial report received from a health care professional on 25 October 2010. A 28-30 year old female (age not exact) received on 25 October 2010 a 0.5 millimeters right forearm intradermal injection of FLUZONE, lot number U3616CA. The patient had received a flu vaccine and an H1N1 vaccine in the past. On the 25 October 2010 the patient developed a large raised wheal that disappeared in 15 minutes and a quarter size red area that remained at injection site. The patient required an emergency room visit. No further information was available. The outcome was not reported. Follow-up information was received by a health care professional on 06 December 2010 reported that the patient was a 27-year-old female who received the FLUZONE on 25 October 2011 in the AM. The patient was monitored by the employee health office and photographs were taken. The patient had no illness at the time of vaccination. The outcome was reported as recovered. Documents held by sender: None.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dry mouth, Dyspnoea, Gait disturbance, Myalgia
Clinical narrative: Initial report received from a consumer on 28 October 2010. A 79-year-old female patient, with a medical history of bilateral cataract removal, diabetes and asthma, receive on 07 October 2010 an injection (route and site not provided) of INFLUENZA VACCINE, lot number not reported. On 07 October 2010, the patient developed muscle aches and pains, dry mouth, nausea, difficulty walking, weakness, chest congestion and shortness of breath. Her concomitant medications included PROAIR and insulin. The patient notified her physician and no medical intervention was given. The patient's symptoms were reported as resolving. Follow-up information was received 11 February 2011 from a health care professional. The patient had additional medical history of psoriasis. According to the reporter, the patient recovered (date not reported). No additional information was provided. Follow-up information was received 04 April 2011 from a health care professional. The patient received an intramuscular left arm injection of FLUZONE, lot number UT3569AA. No further information was received at the time of the report. The patient's outcome remained recovered. Documents held by sender: None.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Respiratory tract congestion
Clinical narrative: Initial report received from a consumer on 28 October 2010. A 79-year-old female patient, with a medical history of bilateral cataract removal, diabetes and asthma, receive on 07 October 2010 an injection (route and site not provided) of INFLUENZA VACCINE, lot number not reported. On 07 October 2010, the patient developed muscle aches and pains, dry mouth, nausea, difficulty walking, weakness, chest congestion and shortness of breath. Her concomitant medications included PROAIR and insulin. The patient notified her physician and no medical intervention was given. The patient's symptoms were reported as resolving. Follow-up information was received 11 February 2011 from a health care professional. The patient had additional medical history of psoriasis. According to the reporter, the patient recovered (date not reported). No additional information was provided. Follow-up information was received 04 April 2011 from a health care professional. The patient received an intramuscular left arm injection of FLUZONE, lot number UT3569AA. No further information was received at the time of the report. The patient's outcome remained recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Initial report received from a health care professional on 02 September 2011. A female patient in her 30's (birth date not provided) received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur Inc. lot number UH453AA, on 31 August 2011. The patient's medical history was unknown. On 02 September 2011, the patient experienced warmth, and swelling at the injection site. She has a fever and general flu like symptoms. The outcome was reported as not recovered. Documents held by sender: None.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Productive cough, Sputum increased
Clinical narrative: Initial report was received on 01 October 2010 and 26 October 2010 from a health care professional. A 54 year-old male patient with a history of an upper respiratory infection (URI) after receiving a "flu" vaccine at age 49 and also in the "1980s", had received a left deltoid (LD) injection of FLUZONE, lot number UT3569BA (route not reported) on 30 September 2010 and the next day, experienced a productive cough, increased chest mucous (mucus) and weakness in the chest. Concomitant medications include niacin, FLOMAX, metoprolol, PREVACID, ASA and multi vitamins. 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
Symptoms: Inflammation, Oedema peripheral
Clinical narrative: Initial report was received on 15 September 2011 from a health care professional. A female patient with reported allergies of PCN, ADVICORE and niacin, had received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE, lot number UH458AA (date of administration not reported) and an unspecified amount of time later, experienced swelling and inflammation from the shoulder to the elbow. The patient was evaluated by a physician. Treatments were not reported. The patient has had FLUVIRIN in the past years. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Condition aggravated, Injected limb mobility decreased, Musculoskeletal pain, Myalgia
Clinical narrative: Initial report was received 03 December 2010 from a health care professional. An elderly female patient had received an injection of FLUZONE HIGH-DOSE, lot number U3608AA (route, site and date of administration not reported) and two days later, she could not move her shoulder. Outcome was not reported. No additional information was provided at the time of the report. Follow-up information was received from a health care professional on 08 December 2010. The patient was an 87-year-old female. The patient had a history of colon cancer, degenerative joint disease (DJD) and lymphoma. The patient's concomitant medications included prednisone (long term) and LEXAPRO. She had no known allergies (NKA) and no illness at the time of vaccination. The patient received an intramuscular left deltoid injection of the FLUZONE HIGH-DOSE on 08 November 2010. Two days after the vaccine on 10 November 2010, the patient could not move her left arm. She was seen in the office on 02 December 2010 and still could not move her left arm and had a tender tricep muscle. She was seen again in the office on 06 December 2010 and her arm movement improved during the 4 days on prednisone. When the patient stopped the prednisone, she could not move the left arm again. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 03 January 2011 reported that the patient had received chemotherapy. She had no other vaccinations within 4 weeks of the FLUZONE HIGH DOSE. In May 2010, her oncologist had reported that when she was weaned off steroids all together, the patient noted more arthritic type pain in her arms and shoulders. The patient was put back on prednisone 5 milligrams (mg) a day after the flu vaccine for pain that was different in that she could not even raise her left arm. The patient was put on prednisone 20 mg for 4 days and then back to 5 mg daily. The patient felt better and cancelled her magnetic resonance imaging (MRI) that was scheduled for the 16 December 2010. However, the patient's left arm and shoulder pain still comes and goes. The patient was re-scheduled to have an MRI soon. The patient was treated for the pain with VOLTAREN. The outcome remained not recovered. Follow-up information received from a nurse on 07 February 2011. The patient spoke with the physician and stated she was feeling better, she cancelled her MRI again. The physician feels more comfortable that the patient's intermittent symptoms are probably due to her arthritis/DJD and not due to the vaccine. The subject has medical history of degenerative joint disease. Follow-up information was received from a health care professional on 14 March 2011. The reporter stated they had no additional information to provide at this time. The patient's outcome remained not recovered. Document held by sender: None.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Osteoarthritis
Clinical narrative: Initial report was received 03 December 2010 from a health care professional. An elderly female patient had received an injection of FLUZONE HIGH-DOSE, lot number U3608AA (route, site and date of administration not reported) and two days later, she could not move her shoulder. Outcome was not reported. No additional information was provided at the time of the report. Follow-up information was received from a health care professional on 08 December 2010. The patient was an 87-year-old female. The patient had a history of colon cancer, degenerative joint disease (DJD) and lymphoma. The patient's concomitant medications included prednisone (long term) and LEXAPRO. She had no known allergies (NKA) and no illness at the time of vaccination. The patient received an intramuscular left deltoid injection of the FLUZONE HIGH-DOSE on 08 November 2010. Two days after the vaccine on 10 November 2010, the patient could not move her left arm. She was seen in the office on 02 December 2010 and still could not move her left arm and had a tender tricep muscle. She was seen again in the office on 06 December 2010 and her arm movement improved during the 4 days on prednisone. When the patient stopped the prednisone, she could not move the left arm again. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 03 January 2011 reported that the patient had received chemotherapy. She had no other vaccinations within 4 weeks of the FLUZONE HIGH DOSE. In May 2010, her oncologist had reported that when she was weaned off steroids all together, the patient noted more arthritic type pain in her arms and shoulders. The patient was put back on prednisone 5 milligrams (mg) a day after the flu vaccine for pain that was different in that she could not even raise her left arm. The patient was put on prednisone 20 mg for 4 days and then back to 5 mg daily. The patient felt better and cancelled her magnetic resonance imaging (MRI) that was scheduled for the 16 December 2010. However, the patient's left arm and shoulder pain still comes and goes. The patient was re-scheduled to have an MRI soon. The patient was treated for the pain with VOLTAREN. The outcome remained not recovered. Follow-up information received from a nurse on 07 February 2011. The patient spoke with the physician and stated she was feeling better, she cancelled her MRI again. The physician feels more comfortable that the patient's intermittent symptoms are probably due to her arthritis/DJD and not due to the vaccine. The subject has medical history of degenerative joint disease. Follow-up information was received from a health care professional on 14 March 2011. The reporter stated they had no additional information to provide at this time. The patient's outcome remained not recovered. Document held by sender: None.
Age: 34.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient given varicella due to low titers. Chickenpox lesions 1 1/2 days later (wife had chicken pox).
Age: 42.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Inflammation, Urticaria
Clinical narrative: Inflammation under armpit of left arm and raised horizontal welts day after vaccination given. Dr. referred patient to Urgent Care, lasted 1-2 days.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle tightness, Pain, Speech disorder
Clinical narrative: Hours after high dose vaccine given patient began to feel achy in whole body, then she felt jaw tightness and experienced difficulty speaking. This lasted about 2 1/2 weeks. Has had regular dose last 16 years with no problem.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Blood glucose increased, Chest discomfort, Headache, Musculoskeletal pain, Neck pain
Clinical narrative: Patient called & said he's been having intense headache/congestion pain (some pain also in neck/shoulders) & chest "tightness"/heaviness. He said his blood sugar was over 400 at 7 PM, so he used HUMULIN R. He said at 9 PM he had a reading over 400 again & again used HUMULIN R. He said he checked his temp. & has no fever. He said he had some congestion on 11/12/11 but today (11/13/11) felt worse & high blood sugar, etc. (advised to go to E.R.).
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Sinus congestion
Clinical narrative: Patient called & said he's been having intense headache/congestion pain (some pain also in neck/shoulders) & chest "tightness"/heaviness. He said his blood sugar was over 400 at 7 PM, so he used HUMULIN R. He said at 9 PM he had a reading over 400 again & again used HUMULIN R. He said he checked his temp. & has no fever. He said he had some congestion on 11/12/11 but today (11/13/11) felt worse & high blood sugar, etc. (advised to go to E.R.).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Pt presented about 2 months following vaccine stating she started feeling internal pain in her (L) upper arm around the site of injection about a week for following the shot and it still continues regularly when she raises her arm. Pt is going to f/u w/PCP the week of 11/20/11.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site induration, Skin warm
Clinical narrative: Patient's left arm was red that wrapped around the arm and was warm to the touch. Injection site was hard. Received vaccine on 11/16/11 and reported the event on 11/18/11. Redness had reduced by then.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Throat tightness
Clinical narrative: Patient was given Fluzone vaccine (Lot UT499AA Exp 6/30/12) IM at approximately 11:35am at a worksite health fair.  This was his first time receiving a flu vaccination.  After approximately 10 minutes, patient reported having a heaviness in his chest and tightness in his throat.  He also complained of feeling short of breath.  No signs of rash, swelling of tongue or throat, and patient was alert.  We had him sit for a few minutes and monitored his symptoms.  At approximately 11:55am, the ambulance was called, and patient was taken to hospital.  He was treated with prednisone and Allegra, then released.  I was not able to reach the patient for further follow up.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: Shot hurt right away, worse by the minute never got better seen DR on 11/02/11 (2 weeks later) was put on Mobic for the first 5 days was getting better then by the last 3 days was coming back. Pain in shoulder struggle getting dressed & brushing hair. Getting another visit to Dr this next week. Lucky I ask for in my left arm. Shot was given high is shoulder have never had pain immediately after like this and then did not go away. I now can not lift my arm over my head to get dressed without severe pain. The only relief was with the Mobic and that was only the first 5-7 days.
Age: 11.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Convulsion, Gaze palsy, Immediate post-injection reaction, Posturing, Syncope
Clinical narrative: Pt immediately after receiving vaccine HPV appeared to have fainted, also appeared to have brief (20 sec) seizure activity.  Non responsive, posturing with arms, eye rolling back.  Completely responsive within one minute.  After juice and 5 min was "back to himself".  Observed for a continued 30 min.
Age: 11.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Pt immediately after receiving vaccine HPV appeared to have fainted, also appeared to have brief (20 sec) seizure activity.  Non responsive, posturing with arms, eye rolling back.  Completely responsive within one minute.  After juice and 5 min was "back to himself".  Observed for a continued 30 min.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Vertigo
Clinical narrative: Started with dizziness around 5 PM.  The next morning when I awoke at 7 AM I experienced extreme vertigo.  Dizziness & fatigue continued throughout the day into the night, for a total of 40 hours.  After that I was fine.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Blood test, Chills, Diarrhoea, Dizziness
Clinical narrative: Chills, Sweats, vomiting, diarrhea, dizziness, weakness, spots before my eyes, resulting in admittance to the emergency dept. of the local hospital.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Hyperhidrosis, Nuclear magnetic resonance imaging, Visual impairment, Vomiting, X-ray
Clinical narrative: Chills, Sweats, vomiting, diarrhea, dizziness, weakness, spots before my eyes, resulting in admittance to the emergency dept. of the local hospital.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: Fever chills.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Body temperature increased, Breast induration, Breast pain, Breast swelling
Clinical narrative: Temp 102.4 and has continued to spike everynight and awakened patient. Arm injection was given in swelled was extremely painful, r breast swelled indurated and painful (had procedure 9/2/2011) but physicians at breast center are blaming vaccine because of swelling in r upper arm and pain in r arm with movement. Nausea, diarrhea, feeling weak and lightheaded, headache, chest/breast pain.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Diarrhoea, Dizziness, Headache, Injection site swelling
Clinical narrative: Temp 102.4 and has continued to spike everynight and awakened patient. Arm injection was given in swelled was extremely painful, r breast swelled indurated and painful (had procedure 9/2/2011) but physicians at breast center are blaming vaccine because of swelling in r upper arm and pain in r arm with movement. Nausea, diarrhea, feeling weak and lightheaded, headache, chest/breast pain.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Oedema peripheral, Pain in extremity
Clinical narrative: Temp 102.4 and has continued to spike everynight and awakened patient. Arm injection was given in swelled was extremely painful, r breast swelled indurated and painful (had procedure 9/2/2011) but physicians at breast center are blaming vaccine because of swelling in r upper arm and pain in r arm with movement. Nausea, diarrhea, feeling weak and lightheaded, headache, chest/breast pain.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Injection site reaction, Myalgia, Pain, Pain in extremity
Clinical narrative: Pain in the muscle from the injection that never subsided. Left arm in constant pain with when raised or rotated. Interferes with daily living. Interrupts sleeping. Need Tylenol at all times.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Sleep disorder
Clinical narrative: Pain in the muscle from the injection that never subsided. Left arm in constant pain with when raised or rotated. Interferes with daily living. Interrupts sleeping. Need Tylenol at all times.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Pain, Pyrexia, Tachycardia
Clinical narrative: Fever, chills, severe body aches, generalized weakness, tachycardia.
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Pain at injection site, swelling at injection site, headache, fatigue, stiff neck and upper back.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Anxiety, Barium enema normal, Blood test normal, Colonoscopy normal
Clinical narrative: Fatigue, stomach pain, fainting spells, anxiety attacks, feelings of pins and needles through legs and arms, shortness of breath, blurry vision.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Dyspnoea, Fatigue, Oesophagogastroduodenoscopy, Paraesthesia
Clinical narrative: Fatigue, stomach pain, fainting spells, anxiety attacks, feelings of pins and needles through legs and arms, shortness of breath, blurry vision.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vision blurred, X-ray normal
Clinical narrative: Fatigue, stomach pain, fainting spells, anxiety attacks, feelings of pins and needles through legs and arms, shortness of breath, blurry vision.
Age: 24.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Lymphadenopathy, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Headache, body ache, sore arm and shoulder. 11/19/2011 - noticed swollen lymph node at collar bone and continued pain and headache.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Lethargy, Pallor, Vomiting
Clinical narrative: Pt had 6 episodes of vomiting in 30 mins, pale, lethargic; went to ER, was rehydrated with oral PEDIALYTE, then discharged home.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Eyelid oedema, Ocular hyperaemia, Pharyngeal erythema, Pharyngeal oedema
Clinical narrative: Red puffy eyes. Red swollen throat. Tight chest. Tx: 4 BENADRYL 25mg over 24 hours.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Hypertrophy, Skull malformation
Clinical narrative: Severe cranial hypertrophy.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Pain at site, muscle cramps; proceeded to swelling size of 50 cent piece with tenderness at site, continued muscle cramps, pain/redness/itching at site; on 11/18/2011 slight elevation of temp to 99, continued pain/itchy/red/elevated hard at site, muscle cramps and pain, fatigue; seen in Employee Health at Hospital.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Muscle spasms, Myalgia
Clinical narrative: Pain at site, muscle cramps; proceeded to swelling size of 50 cent piece with tenderness at site, continued muscle cramps, pain/redness/itching at site; on 11/18/2011 slight elevation of temp to 99, continued pain/itchy/red/elevated hard at site, muscle cramps and pain, fatigue; seen in Employee Health at Hospital.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Eyelid oedema, Urticaria
Clinical narrative: Woke up with swollen eyelids, like hives.  Also, hive on forehead and wrist.  Otherwise, feels okay.  Spoke to doctor on call (not our usual doctor) and administered liquid Benadryl.  Waiting to see what ensues.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dysphagia, Dysphonia, Heart rate increased, Lacrimation increased
Clinical narrative: Throat became tight; heart rate slightly elevated; eyes began to water; nausea; extremely cold/shivering; voice hoarse (most likely from throat tightness); difficulty swallowing.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Nasopharyngitis, Nausea, Throat tightness
Clinical narrative: Throat became tight; heart rate slightly elevated; eyes began to water; nausea; extremely cold/shivering; voice hoarse (most likely from throat tightness); difficulty swallowing.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Chest pain, Flank pain, Inflammation, Injection site pain
Clinical narrative: I got the flu shot at facility, agency came on site to give flu shot for employees. Right after I got flu shot in my right arm, felt obvious pain compared with previous years (I had flu shot for over ten years), after 7 days the pain didn't get any relief, two weeks later, the pain spread from shot spot to whole shoulder, up and low arm, right chest and back, now 40 days passed, I still had pain in my right side, saw my family doctor, he said I had inflammation obviously, prescribed two medicines for me, said if still not good after these medication, I need to see a specialist.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: I got the flu shot at facility, agency came on site to give flu shot for employees. Right after I got flu shot in my right arm, felt obvious pain compared with previous years (I had flu shot for over ten years), after 7 days the pain didn't get any relief, two weeks later, the pain spread from shot spot to whole shoulder, up and low arm, right chest and back, now 40 days passed, I still had pain in my right side, saw my family doctor, he said I had inflammation obviously, prescribed two medicines for me, said if still not good after these medication, I need to see a specialist.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Oedema peripheral, Pain in extremity
Clinical narrative: C/O pain to her left arm. It is swollen and firm and red today. It is sore per MOTHER OF CHILD.
Age: 28.0
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Slight rash outbreak displaying as a few small reddish bumps, with no head or color appearance other than red. Seen on stomach  and number approximately 10 in count. Additionally, a fever of approximately 101.7 (taken under the arm by digital thermometer). Was given appropriate dosage of Acetaminophen at home, and fever subsided. Symptoms still ongoing. Shows normal behavioral signs besides the slight fever and few bumps.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Aortic valve incompetence, Cardiac enzymes increased, Catheterisation cardiac normal, Chest pain, Dyspnoea
Clinical narrative: Sudden onset of shortness of breath while vacuuming that worsened over the course of the next several hours. ER visit and hospitalization for elevated cardiac markers, transferred to tertiary facility for further care. Diagnosed with Takotsubo syndrome (apical ballooning). Intermittent episodes of chest pain and shortness of breath for several months following. Did seem to recover until recent visit with recurrent symptoms of shortness of breath and swelling in the legs.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram abnormal, Oedema peripheral, Stress cardiomyopathy
Clinical narrative: Sudden onset of shortness of breath while vacuuming that worsened over the course of the next several hours. ER visit and hospitalization for elevated cardiac markers, transferred to tertiary facility for further care. Diagnosed with Takotsubo syndrome (apical ballooning). Intermittent episodes of chest pain and shortness of breath for several months following. Did seem to recover until recent visit with recurrent symptoms of shortness of breath and swelling in the legs.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Tricuspid valve incompetence
Clinical narrative: Sudden onset of shortness of breath while vacuuming that worsened over the course of the next several hours. ER visit and hospitalization for elevated cardiac markers, transferred to tertiary facility for further care. Diagnosed with Takotsubo syndrome (apical ballooning). Intermittent episodes of chest pain and shortness of breath for several months following. Did seem to recover until recent visit with recurrent symptoms of shortness of breath and swelling in the legs.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Infection, Injection site erythema, Injection site pain, Oedema peripheral
Clinical narrative: Arm became swollen from underarm to finger tips to mid back, extreme pain, redness around injection site.  ER doc ordered ultrasound and blood work.  I saw my PCP to follow up who stated I had infection directly related to injection.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound scan
Clinical narrative: Arm became swollen from underarm to finger tips to mid back, extreme pain, redness around injection site.  ER doc ordered ultrasound and blood work.  I saw my PCP to follow up who stated I had infection directly related to injection.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Nasopharyngitis, Vertigo
Clinical narrative: Initially cold/flu symptoms within 12 hours, then developed vertigo that has taken about 6 weeks to resolve.  This is the 3rd time that I can remember that I've had vertigo very closely associated with timing of flu shot.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Cardiac stress test, Chest discomfort, Discomfort, Dysphagia
Clinical narrative: Tightness of chest, difficulty breathing, general body discomfort, difficulty swallowing, high blood pressure.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypertension
Clinical narrative: Tightness of chest, difficulty breathing, general body discomfort, difficulty swallowing, high blood pressure.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Dry mouth, Headache, Muscular weakness
Clinical narrative: Fever, chills, teeth chattering, headache, muscular weakness, dry mouth, diarrhea.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Fever, chills, teeth chattering, headache, muscular weakness, dry mouth, diarrhea.
Age: 42.0
Sex: F
Vaccine: TDAP, DT
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, X-ray
Clinical narrative: Initial report was received on 17 August 2011 from a health care professional. A female patient with no reported medical history had received ADACEL (lot number, route, site and date of administration not reported) and the morning after receiving the vaccine, experienced pain in her arm upon movement. The movement returned after one week. She was evaluated by an orthopedist on 28 July (year not reported) and physical therapy on 03 August (year not reported). No further information was provided at the time of the report. The patient's outcome was reported as she still had pain when she tried to "reach up and behind" (not recovered). Follow-up information was received from a health care professional (who was the consumer) on 14 November 2011. The patient's medical history was negative except for migraine headaches which started at age 15 years. Her concomitant medications for the migraines included EFFEXOR XR 75 milligrams (mg) every morning (AM), TOPAMAX 150 mg at bedtime (q HS) and IMITREX 100 mg as needed for a headache (prn) not to exceed 4 doses in 24 hours. She also took MOBIC 15 mg z AM for an anti-inflammatory. She was 3 months post-op arthroscopic surgery in the left ankle and had restarted it after working in the rubble and having some pain. The patient received an intramuscular right deltoid injection with a one inch needle of DECAVAC (previously reported as ADACEL), sanofi pasteur Inc. lot number U3768AA, on 13 June 2011. The patient was seen by an orthopedic surgeon on 25 August 2011 and was scheduled for arthroscopic surgery on the shoulder. Physical therapy (PT) visits were not helping and the pain increased and her range of motion was decreasing. The doctor felt that the patient may have a small tear in the rotator cuff as well as bone spurs that was seen on x-ray. Surgery was performed on 02 September 2011 and revealed no tears but instead a diagnosis of frozen shoulder. The bone spurs and scarring were removed and manipulation of the joint was done under anesthesia. Physical therapy for aggressive range of motion was started four days after surgery. The patient still continues to have problems with muscle spasms in the deltoid and bicep area of the right arm making rehabilitation difficult. The patient was started on SKELAXIN 800 mg three time a day (TID) to help keep the muscles relaxed enough to allow exercises and passive range of motion (ROM) to continue. Nine weeks after surgery, the patient was still doing daily PT at home as well as massage as needed since her arm muscles continued to cause pain and get hard painful knots that had to be massaged out, especially after extensive stretching exercises with her arm up over her head. She still does not have full range of motion of her arm. She can not reach behind her back fully or fully extend her arm above her head. The patient has a follow-up appointment at the orthopedist on 30 November 2011 for a 12 week post-op visit. The outcome was reported as not recovered. Documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: TDAP, DT
Symptoms: Arthroscopic surgery, Exostosis, Joint manipulation, Joint range of motion decreased, Muscle spasms
Clinical narrative: Initial report was received on 17 August 2011 from a health care professional. A female patient with no reported medical history had received ADACEL (lot number, route, site and date of administration not reported) and the morning after receiving the vaccine, experienced pain in her arm upon movement. The movement returned after one week. She was evaluated by an orthopedist on 28 July (year not reported) and physical therapy on 03 August (year not reported). No further information was provided at the time of the report. The patient's outcome was reported as she still had pain when she tried to "reach up and behind" (not recovered). Follow-up information was received from a health care professional (who was the consumer) on 14 November 2011. The patient's medical history was negative except for migraine headaches which started at age 15 years. Her concomitant medications for the migraines included EFFEXOR XR 75 milligrams (mg) every morning (AM), TOPAMAX 150 mg at bedtime (q HS) and IMITREX 100 mg as needed for a headache (prn) not to exceed 4 doses in 24 hours. She also took MOBIC 15 mg z AM for an anti-inflammatory. She was 3 months post-op arthroscopic surgery in the left ankle and had restarted it after working in the rubble and having some pain. The patient received an intramuscular right deltoid injection with a one inch needle of DECAVAC (previously reported as ADACEL), sanofi pasteur Inc. lot number U3768AA, on 13 June 2011. The patient was seen by an orthopedic surgeon on 25 August 2011 and was scheduled for arthroscopic surgery on the shoulder. Physical therapy (PT) visits were not helping and the pain increased and her range of motion was decreasing. The doctor felt that the patient may have a small tear in the rotator cuff as well as bone spurs that was seen on x-ray. Surgery was performed on 02 September 2011 and revealed no tears but instead a diagnosis of frozen shoulder. The bone spurs and scarring were removed and manipulation of the joint was done under anesthesia. Physical therapy for aggressive range of motion was started four days after surgery. The patient still continues to have problems with muscle spasms in the deltoid and bicep area of the right arm making rehabilitation difficult. The patient was started on SKELAXIN 800 mg three time a day (TID) to help keep the muscles relaxed enough to allow exercises and passive range of motion (ROM) to continue. Nine weeks after surgery, the patient was still doing daily PT at home as well as massage as needed since her arm muscles continued to cause pain and get hard painful knots that had to be massaged out, especially after extensive stretching exercises with her arm up over her head. She still does not have full range of motion of her arm. She can not reach behind her back fully or fully extend her arm above her head. The patient has a follow-up appointment at the orthopedist on 30 November 2011 for a 12 week post-op visit. The outcome was reported as not recovered. Documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: TDAP, DT
Symptoms: Myalgia, Pain, Pain in extremity, Periarthritis, Rotator cuff syndrome
Clinical narrative: Initial report was received on 17 August 2011 from a health care professional. A female patient with no reported medical history had received ADACEL (lot number, route, site and date of administration not reported) and the morning after receiving the vaccine, experienced pain in her arm upon movement. The movement returned after one week. She was evaluated by an orthopedist on 28 July (year not reported) and physical therapy on 03 August (year not reported). No further information was provided at the time of the report. The patient's outcome was reported as she still had pain when she tried to "reach up and behind" (not recovered). Follow-up information was received from a health care professional (who was the consumer) on 14 November 2011. The patient's medical history was negative except for migraine headaches which started at age 15 years. Her concomitant medications for the migraines included EFFEXOR XR 75 milligrams (mg) every morning (AM), TOPAMAX 150 mg at bedtime (q HS) and IMITREX 100 mg as needed for a headache (prn) not to exceed 4 doses in 24 hours. She also took MOBIC 15 mg z AM for an anti-inflammatory. She was 3 months post-op arthroscopic surgery in the left ankle and had restarted it after working in the rubble and having some pain. The patient received an intramuscular right deltoid injection with a one inch needle of DECAVAC (previously reported as ADACEL), sanofi pasteur Inc. lot number U3768AA, on 13 June 2011. The patient was seen by an orthopedic surgeon on 25 August 2011 and was scheduled for arthroscopic surgery on the shoulder. Physical therapy (PT) visits were not helping and the pain increased and her range of motion was decreasing. The doctor felt that the patient may have a small tear in the rotator cuff as well as bone spurs that was seen on x-ray. Surgery was performed on 02 September 2011 and revealed no tears but instead a diagnosis of frozen shoulder. The bone spurs and scarring were removed and manipulation of the joint was done under anesthesia. Physical therapy for aggressive range of motion was started four days after surgery. The patient still continues to have problems with muscle spasms in the deltoid and bicep area of the right arm making rehabilitation difficult. The patient was started on SKELAXIN 800 mg three time a day (TID) to help keep the muscles relaxed enough to allow exercises and passive range of motion (ROM) to continue. Nine weeks after surgery, the patient was still doing daily PT at home as well as massage as needed since her arm muscles continued to cause pain and get hard painful knots that had to be massaged out, especially after extensive stretching exercises with her arm up over her head. She still does not have full range of motion of her arm. She can not reach behind her back fully or fully extend her arm above her head. The patient has a follow-up appointment at the orthopedist on 30 November 2011 for a 12 week post-op visit. The outcome was reported as not recovered. Documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: TDAP, DT
Symptoms: Scar excision, X-ray abnormal
Clinical narrative: Initial report was received on 17 August 2011 from a health care professional. A female patient with no reported medical history had received ADACEL (lot number, route, site and date of administration not reported) and the morning after receiving the vaccine, experienced pain in her arm upon movement. The movement returned after one week. She was evaluated by an orthopedist on 28 July (year not reported) and physical therapy on 03 August (year not reported). No further information was provided at the time of the report. The patient's outcome was reported as she still had pain when she tried to "reach up and behind" (not recovered). Follow-up information was received from a health care professional (who was the consumer) on 14 November 2011. The patient's medical history was negative except for migraine headaches which started at age 15 years. Her concomitant medications for the migraines included EFFEXOR XR 75 milligrams (mg) every morning (AM), TOPAMAX 150 mg at bedtime (q HS) and IMITREX 100 mg as needed for a headache (prn) not to exceed 4 doses in 24 hours. She also took MOBIC 15 mg z AM for an anti-inflammatory. She was 3 months post-op arthroscopic surgery in the left ankle and had restarted it after working in the rubble and having some pain. The patient received an intramuscular right deltoid injection with a one inch needle of DECAVAC (previously reported as ADACEL), sanofi pasteur Inc. lot number U3768AA, on 13 June 2011. The patient was seen by an orthopedic surgeon on 25 August 2011 and was scheduled for arthroscopic surgery on the shoulder. Physical therapy (PT) visits were not helping and the pain increased and her range of motion was decreasing. The doctor felt that the patient may have a small tear in the rotator cuff as well as bone spurs that was seen on x-ray. Surgery was performed on 02 September 2011 and revealed no tears but instead a diagnosis of frozen shoulder. The bone spurs and scarring were removed and manipulation of the joint was done under anesthesia. Physical therapy for aggressive range of motion was started four days after surgery. The patient still continues to have problems with muscle spasms in the deltoid and bicep area of the right arm making rehabilitation difficult. The patient was started on SKELAXIN 800 mg three time a day (TID) to help keep the muscles relaxed enough to allow exercises and passive range of motion (ROM) to continue. Nine weeks after surgery, the patient was still doing daily PT at home as well as massage as needed since her arm muscles continued to cause pain and get hard painful knots that had to be massaged out, especially after extensive stretching exercises with her arm up over her head. She still does not have full range of motion of her arm. She can not reach behind her back fully or fully extend her arm above her head. The patient has a follow-up appointment at the orthopedist on 30 November 2011 for a 12 week post-op visit. The outcome was reported as not recovered. Documents held by sender: none.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Initial report received from a health care professional on 14 November 2011. The reporter also reported another adverse event, which was captured in case number 2011-11078. An unidentified patient (age and sex not reported) received an intramuscular injection (site not reported) of FLUZONE, sanofi pasteur Inc. lot number UH468AA, on an unknown date. The patient's medical history and concomitant medications were unknown. It was unknown if the patient had any adverse events following prior vaccinations. The patient had no illness at the time of vaccination. On an unknown date, the patient developed cellulitis at the injection site. The patient's diagnostic or laboratory testing was not reported. The outcome was reported as unknown. Documents held by sender: None.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Initial report received from a health care professional on 14 November 2011. The reporter also reported another adverse event, which was captured in case number 2011-11078. An unidentified patient (age and sex not reported) received an intramuscular injection (site not reported) of FLUZONE, sanofi pasteur Inc. lot number UH468AA, on an unknown date. The patient's medical history and concomitant medications were unknown. It was unknown if the patient had any adverse events following prior vaccinations. The patient had no illness at the time of vaccination. On an unknown date, the patient developed cellulitis at the injection site. The patient's diagnostic or laboratory testing was not reported. The outcome was reported as unknown. Documents held by sender: None.
Age: 90.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest pain, Dysphonia, Hypokinesia, Pain, Swollen tongue
Clinical narrative: Initial report was received on 1 November 2011 from a consumer who is also the patient's daughter. A 90 year-old female patient with a history of MI's (myocardial infarctions) had received FLUZONE HIGH-DOSE (lot number, route and site of administration not reported) on 09 September 2011 and at 4 AM the next day 10 September 2011, experienced "symptoms" of a heart attack that caused her to fall, tongue swelling and hoarseness inhibiting her capability to speak and swallow. EMT's (emergency medical technicians) treated the patient based on her PMH (past medical history) of heart attacks and symptomology. She was transported to the ED (emergency department). The ER (emergency room) physician informed the patient's daughter that the patient had been treated for a heart attack but "there is something else going on but we don't know what it is". The patient was hospitalized. According to the reporter, throughout hospitalization the patient developed internal bleeding, ARF (acute renal failure resulting in hemodialysis, respiratory and heart failure. The patient was placed on total life support and died on 27 September 2011. No autopsy was conducted per the family. The medical examiner reported the cause of death to be multisystem organ failure, sepsis and aspiration pneumonia. According to the reporter, she feels her mother experienced a "serious reaction" to the flu vaccine and it was "probably what had killed her." No further information was available at the time of the report. Outcome was fatal. Documents held by sender: none.
Age: 90.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Wheezing
Clinical narrative: Initial report was received on 1 November 2011 from a consumer who is also the patient's daughter. A 90 year-old female patient with a history of MI's (myocardial infarctions) had received FLUZONE HIGH-DOSE (lot number, route and site of administration not reported) on 09 September 2011 and at 4 AM the next day 10 September 2011, experienced "symptoms" of a heart attack that caused her to fall, tongue swelling and hoarseness inhibiting her capability to speak and swallow. EMT's (emergency medical technicians) treated the patient based on her PMH (past medical history) of heart attacks and symptomology. She was transported to the ED (emergency department). The ER (emergency room) physician informed the patient's daughter that the patient had been treated for a heart attack but "there is something else going on but we don't know what it is". The patient was hospitalized. According to the reporter, throughout hospitalization the patient developed internal bleeding, ARF (acute renal failure resulting in hemodialysis, respiratory and heart failure. The patient was placed on total life support and died on 27 September 2011. No autopsy was conducted per the family. The medical examiner reported the cause of death to be multisystem organ failure, sepsis and aspiration pneumonia. According to the reporter, she feels her mother experienced a "serious reaction" to the flu vaccine and it was "probably what had killed her." No further information was available at the time of the report. Outcome was fatal. Documents held by sender: none.
Age: 90.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cardiac disorder, Cardiac failure, Death, Dysphagia, Dysphonia
Clinical narrative: Initial report was received on 1 November 2011 from a consumer who is also the patient's daughter. A 90 year-old female patient with a history of MI's (myocardial infarctions) had received FLUZONE HIGH-DOSE (lot number, route and site of administration not reported) on 09 September 2011 and at 4 AM the next day 10 September 2011, experienced "symptoms" of a heart attack that caused her to fall, tongue swelling and hoarseness inhibiting her capability to speak and swallow. EMT's (emergency medical technicians) treated the patient based on her PMH (past medical history) of heart attacks and symptomology. She was transported to the ED (emergency department). The ER (emergency room) physician informed the patient's daughter that the patient had been treated for a heart attack but "there is something else going on but we don't know what it is". The patient was hospitalized. According to the reporter, throughout hospitalization the patient developed internal bleeding, ARF (acute renal failure resulting in hemodialysis, respiratory and heart failure. The patient was placed on total life support and died on 27 September 2011. No autopsy was conducted per the family. The medical examiner reported the cause of death to be multisystem organ failure, sepsis and aspiration pneumonia. According to the reporter, she feels her mother experienced a "serious reaction" to the flu vaccine and it was "probably what had killed her." No further information was available at the time of the report. Outcome was fatal. Documents held by sender: none.