chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site pruritus, Muscle disorder, Paraesthesia, Presyncope
Clinical narrative: ADACEL administered at 17:30 hr. Immediately following he was flushed and red in face - feeling dizzy. His hand muscle distorted w/fingers - felt needles in skin - grasped hair. Used ammonia salts under nose to revive him - he did not faint. Breathing was shallow, S.O.B. Told him to breathe - he then said left shoulder & right palm of hand were itchy. Called 911 initially in beginning. Monitored vitals - he was feeling better when paramedics arrived.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: ADACEL administered at 17:30 hr. Immediately following he was flushed and red in face - feeling dizzy. His hand muscle distorted w/fingers - felt needles in skin - grasped hair. Used ammonia salts under nose to revive him - he did not faint. Breathing was shallow, S.O.B. Told him to breathe - he then said left shoulder & right palm of hand were itchy. Called 911 initially in beginning. Monitored vitals - he was feeling better when paramedics arrived.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Fatigue, Laboratory test, Myalgia
Clinical narrative: (Severe fatigue then & now & after shot). (3A Mon 3-8-2011). I awoke with bad Lt hip pain. Upon standing I had pain full back (neck to coccyx) muscles, joints, both arms, forearms, both shoulders, elbows, wrists, hands, fingers. Full upper body & upper extremity severe pain. Rx pain meds, prednisone, antidepressants, antibiotics Lt ear infect. 6-8-2011 3 wks to heal.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: (Severe fatigue then & now & after shot). (3A Mon 3-8-2011). I awoke with bad Lt hip pain. Upon standing I had pain full back (neck to coccyx) muscles, joints, both arms, forearms, both shoulders, elbows, wrists, hands, fingers. Full upper body & upper extremity severe pain. Rx pain meds, prednisone, antidepressants, antibiotics Lt ear infect. 6-8-2011 3 wks to heal.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Balance disorder, Cardiac stress test, Chest pain, Echocardiogram
Clinical narrative: (Severe fatigue then & now & after shot). (3A Mon 3-8-2011). I awoke with bad Lt hip pain. Upon standing I had pain full back (neck to coccyx) muscles, joints, both arms, forearms, both shoulders, elbows, wrists, hands, fingers. Full upper body & upper extremity severe pain. Rx pain meds, prednisone, antidepressants, antibiotics Lt ear infect. 6-8-2011 3 wks to heal.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Electrocardiogram, Fatigue, Grip strength decreased, Laboratory test, Memory impairment
Clinical narrative: (Severe fatigue then & now & after shot). (3A Mon 3-8-2011). I awoke with bad Lt hip pain. Upon standing I had pain full back (neck to coccyx) muscles, joints, both arms, forearms, both shoulders, elbows, wrists, hands, fingers. Full upper body & upper extremity severe pain. Rx pain meds, prednisone, antidepressants, antibiotics Lt ear infect. 6-8-2011 3 wks to heal.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Muscle spasms, Myalgia, Nasal disorder, Pain, Rash
Clinical narrative: (Severe fatigue then & now & after shot). (3A Mon 3-8-2011). I awoke with bad Lt hip pain. Upon standing I had pain full back (neck to coccyx) muscles, joints, both arms, forearms, both shoulders, elbows, wrists, hands, fingers. Full upper body & upper extremity severe pain. Rx pain meds, prednisone, antidepressants, antibiotics Lt ear infect. 6-8-2011 3 wks to heal.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Splint application
Clinical narrative: (Severe fatigue then & now & after shot). (3A Mon 3-8-2011). I awoke with bad Lt hip pain. Upon standing I had pain full back (neck to coccyx) muscles, joints, both arms, forearms, both shoulders, elbows, wrists, hands, fingers. Full upper body & upper extremity severe pain. Rx pain meds, prednisone, antidepressants, antibiotics Lt ear infect. 6-8-2011 3 wks to heal.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test, Myalgia
Clinical narrative: (Severe fatigue then & now & after shot). (3A Mon 3-8-2011). I awoke with bad Lt hip pain. Upon standing I had pain full back (neck to coccyx) muscles, joints, both arms, forearms, both shoulders, elbows, wrists, hands, fingers. Full upper body & upper extremity severe pain. Rx pain meds, prednisone, antidepressants, antibiotics Lt ear infect. 6-8-2011 3 wks to heal.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain
Clinical narrative: Pain in Left shoulder severe at first and tapering but still present at 3 weeks post dose.
Age: 63.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Local reaction, Type IV hypersensitivity reaction, Vaccination site swelling
Clinical narrative: Employee has worsening local reaction. Initially had no problems, but then at about day 10-11 started having swelling, itching, redness at site of the vaccination, about 10cm x 5cm ER MD felt it was a delayed hypersensitivity reaction.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Convulsion, Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: Swelling of arm below elbow, fever - 100.5, red streak on arm/painful, ? fever induced syncope/seizure.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia, Syncope
Clinical narrative: Swelling of arm below elbow, fever - 100.5, red streak on arm/painful, ? fever induced syncope/seizure.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Tenderness, Urticaria
Clinical narrative: red welt 4" by 1.75", swelling, pain and tenderness Left Arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Convulsion, Dyskinesia, Gaze palsy, Pallor, Posture abnormal
Clinical narrative: Child's face went gray, she fainted. I caught her and laid her on the floor. Her head tilted to the side and began jerking and her eyes rolled back in her head. It lasted about 10 seconds from fainting to the end of the seizure.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Syncope
Clinical narrative: Child's face went gray, she fainted. I caught her and laid her on the floor. Her head tilted to the side and began jerking and her eyes rolled back in her head. It lasted about 10 seconds from fainting to the end of the seizure.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Feeling abnormal, Headache, Pain
Clinical narrative: Felt itchy and was welted, started growing and growing..very painful and red.  Measured approx 4" X 1 1/2"....morning about a 1/4" bigger and very sore under my Left arm where shot was given...feel like I'm getting flu, headache, achy, took Benadryl 2 - 2x on 7/8/2011.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Felt itchy and was welted, started growing and growing..very painful and red.  Measured approx 4" X 1 1/2"....morning about a 1/4" bigger and very sore under my Left arm where shot was given...feel like I'm getting flu, headache, achy, took Benadryl 2 - 2x on 7/8/2011.
Age: 0.49
Sex: F
Vaccine: DTAP, HEP, HIBV, PPV
Symptoms: Crying, Diarrhoea haemorrhagic, Gastrointestinal necrosis, Intestinal operation, Intussusception
Clinical narrative: Infant was fussy many days prior, that evening was inconsolable. Late evening-early morning started vomiting and having bloody diarrhea. Went to ER, discharged with diagnosis of "virus" and instructions to give Pedialyte. Went to see pediatrician first thing 9-8-2005. Was sent to hospital to be "observed". Second attending physician, admitted my daughter and found she had an intussusception. Her bowel already died and she was sent in for emergency surgery. Complications surgery wound was infected had to reopen and surgical cut had to be kept open.
Age: 0.49
Sex: F
Vaccine: DTAP, HEP, HIBV, PPV
Symptoms: Irritability, Postoperative wound complication, Postoperative wound infection, Viral infection, Vomiting
Clinical narrative: Infant was fussy many days prior, that evening was inconsolable. Late evening-early morning started vomiting and having bloody diarrhea. Went to ER, discharged with diagnosis of "virus" and instructions to give Pedialyte. Went to see pediatrician first thing 9-8-2005. Was sent to hospital to be "observed". Second attending physician, admitted my daughter and found she had an intussusception. Her bowel already died and she was sent in for emergency surgery. Complications surgery wound was infected had to reopen and surgical cut had to be kept open.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Allergy to vaccine, Cellulitis, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Redness to Lt arm swelling, and pain with itching. Has cellulitis and allergic reaction to vaccine. Will be tx with KEFLEX TID and ATARAX QID.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: Redness to Lt arm swelling, and pain with itching. Has cellulitis and allergic reaction to vaccine. Will be tx with KEFLEX TID and ATARAX QID.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient noticed injection site was red and tender to touch the next evening after the vaccination. (May have been swollen). I examined the site today when she called to ask about the reaction. No pain or swelling today, but still red.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site inflammation, Injection site swelling, Tenderness
Clinical narrative: (L) upper arm swollen, inflamed at deltoid muscle, decreased tenderness & swelling since day after injections given on 7/6/11.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Erythema, Rash pustular
Clinical narrative: Small, circular, rough, red mark on mid chest. Another mark is beginning - does have a small head on it. Not itchy or painful.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Localized redness, mild induration.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Induration, Pain, Pyrexia
Clinical narrative: Pt got shot on Wednesday 7/6/11 at 2:15pm & it started red, hot, swollen 7/7/11 & had fever, aches & diarrhea. She called PCP and was told to take TYLENOL. Kept getting bigger and warmer. On 7/8 called pharmacy and we told her to take BENADRYL & cold compress & draw line around redness, no fever 7/9 and it's not as hot or swollen but the redness is spreading.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Pt got shot on Wednesday 7/6/11 at 2:15pm & it started red, hot, swollen 7/7/11 & had fever, aches & diarrhea. She called PCP and was told to take TYLENOL. Kept getting bigger and warmer. On 7/8 called pharmacy and we told her to take BENADRYL & cold compress & draw line around redness, no fever 7/9 and it's not as hot or swollen but the redness is spreading.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Fall, Feeling abnormal, Gait disturbance, Nausea, Thirst
Clinical narrative: I was pulling weeds and notices that I was feeling a little funny but finished what I was doing. When I stood up to pick up the bag I staggered and dropped it. When I looked up everything looked strange, kind of like it was all messed up and didn't fit together right, maybe a little out of focus. My husband stepped out on the deck right then and I motioned for him to come down and when I started to walk toward him I could only stagger to the right. He caught me as I was falling. He got me in the house and I was very thirsty so drank some water and then felt very nauseous. The right side of my face, right arm and right leg was feeling We waited about 15 min for it to clear up and it didn't so we went to the ER.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Vision blurred
Clinical narrative: I was pulling weeds and notices that I was feeling a little funny but finished what I was doing. When I stood up to pick up the bag I staggered and dropped it. When I looked up everything looked strange, kind of like it was all messed up and didn't fit together right, maybe a little out of focus. My husband stepped out on the deck right then and I motioned for him to come down and when I started to walk toward him I could only stagger to the right. He caught me as I was falling. He got me in the house and I was very thirsty so drank some water and then felt very nauseous. The right side of my face, right arm and right leg was feeling We waited about 15 min for it to clear up and it didn't so we went to the ER.
Age: 1.56
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Blister, Erythema, Irritability, Pyrexia, Rhinorrhoea
Clinical narrative: Started with fussiness and runny nose, then red blisters started to appear on his face around his mouth and on his forehead. Over the next two days the blisters appeared on his trunk and groin and extremities. Fever up to 101.5. He continues to exhibit symptoms and we may take him to the doctor if they persist or increase.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Pyrexia
Clinical narrative: Low grade fever and small red blisters concentrated on face, especially around nose and mouth and forehead. Several on the extremities.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Disorientation, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Weakness, dizziness - significant, severe swelling that got larger to about 10" in the next couple of days, significant heat, sweating, headache, disorientation.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Weakness, dizziness - significant, severe swelling that got larger to about 10" in the next couple of days, significant heat, sweating, headache, disorientation.
Age: 57.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: Persistent global headache that is still ongoing more than 24 hours post vaccination. Neck soreness and stiffness started about 18 hours post vaccination. No meningismus. Only partial relief with acetaminophen.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Dizziness, Syncope, Vomiting
Clinical narrative: dizziness, fainting, vomited
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness at the injection site and hot to touch. Dr gave Cephalexin 500 mg.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dysphonia, Fatigue, Oropharyngeal pain
Clinical narrative: Initial report received from a health care professional on 04 June 2010. A 49-year-old female patient, with a history of allergies to doxycycline, ROBITUSSIN and ampicillin, received an intramuscular injection to right deltoid on 27 May 2010 of ADACEL, lot number C3250AA, and on an unknown date developed weakness and a sore, hoarse throat. The patient was seen by a physician but treatment was not specified. Any vaccinations 4 weeks prior and illness at the time of vaccination were not reported. The outcome was reported as unknown. Follow up information was received 01 July 2010 from health care professional. The patient experienced an additional symptom of fatigue and according to the reporter, all reported symptoms began on approximately 28 May 2010. The patient had not reported any concomitant medications. She was seen and followed by her primary care physician and failed to return any telephone calls or follow up requests with the reporter. According to the reporter treatment and ancillary tests and recovery status were unknown. Follow-up information was received 22 July 2010 from a health care professional who reported that the primary care physician's contact information and patient's recovery status were unknown. Follow-up information received on 11 August 2010 from a health care professional who reported to have no further information provide. Documents held by sender: None.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Initial spontaneous report received from a physician on 27 May 2010. A 48-year-old female patient with a history of diabetes received an intramuscular left arm injection of ADACEL (sanofi pasteur inc lot number UF544CA, sanofi pasteur ltd lot number C3109) on 21 May 2010. Concomitant medication included metformin. Approximately 24 hours after vaccination she began having body aches. Her left arm became red, warm and painful from the deltoid to 2 inches below the elbow. She was seen by her physician on 26 May 2010, at which time the redness had extended outward on the borders, with central clearing noted. She was treated with BENADRYL and prednisone, and the event remained ongoing at the time of the report. Follow-up information was received on 04 October 2010 from a healthcare professional. The reporter stated that the "reaction spread from arm to below elbow." The patient had no relevant diagnostic tests done. She had no vaccinations within 4 weeks and no adverse event following prior vaccinations. The patient recovered on 10 June 2010. Documents held by sender: None. Corrective version was created on 18 October 2010 to follow the new HAs' recommendation to have all the seriousness criteria completed by "yes" or "no".
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Initial spontaneous report received from a physician on 27 May 2010. A 48-year-old female patient with a history of diabetes received an intramuscular left arm injection of ADACEL (sanofi pasteur inc lot number UF544CA, sanofi pasteur ltd lot number C3109) on 21 May 2010. Concomitant medication included metformin. Approximately 24 hours after vaccination she began having body aches. Her left arm became red, warm and painful from the deltoid to 2 inches below the elbow. She was seen by her physician on 26 May 2010, at which time the redness had extended outward on the borders, with central clearing noted. She was treated with BENADRYL and prednisone, and the event remained ongoing at the time of the report. Follow-up information was received on 04 October 2010 from a healthcare professional. The reporter stated that the "reaction spread from arm to below elbow." The patient had no relevant diagnostic tests done. She had no vaccinations within 4 weeks and no adverse event following prior vaccinations. The patient recovered on 10 June 2010. Documents held by sender: None. Corrective version was created on 18 October 2010 to follow the new HAs' recommendation to have all the seriousness criteria completed by "yes" or "no".
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Hypersensitivity, Hypoaesthesia
Clinical narrative: Initial case was received on 11 June 2010 from a healthcare professional. A 44 year old male patient received a left arm intramuscular injection of ADACEL (lot number C3475AA) at 3:15 p.m. on 08 June 2010. At 4:48 p.m. on 08 June 2010 he experienced lightheadedness and numbness on the face. The patient had no illness at the time of the vaccination. He had no pre-existing medical conditions and no known allergies. There were no reported adverse events to prior vaccinations. The patient went to the emergency room (ER) and was treated with BENADRYL. At the time of this report it was unknown if the patient had recovered. Follow-up information was received on 17 June 2010 from a healthcare professional (who received information from the patient). Upon receipt of this information it was determined that the case meets seriousness criteria, and it has been upgraded to serious. After receiving the ADACEL vaccination on 08 June 2010 the patient waited 30 minutes as advised by the pharmacist. On his way home he began feeling lightheaded and a numb, tingling sensation on his right side from the cheek, down his arm to his hand. He felt that he might pass out. Upon arriving home, he laid down, began feeling worse and the numbness moved across his chest and throat. His chest felt tight and he had difficulty breathing. He was seen in the emergency room and the doctor told him he was having an allergic reaction. He was advised in the emergency room to "avoid tetanus shots in the future." The patient's treatment included Albuterol HFA oral inhaler 2 puffs each 6 hours for 1 week, prednisone 20 mg 3 orally every day for 5 days and BENADRYL 25 mg 2 every 6 hours as needed. The patient was to follow-up with his physician within two days. As of 16 June 2010, the patient still had some numbness on the right side of his face. Follow-up information received on 19 July 2010 from a pharmacist. The reporter tried on two different occasions to contact the patient to obtain further information regarding this case and the patient has not returned the phone calls. The reporter contacted the patient's primary care physician and was told the patient had not contacted them either. Documents held by sender: None.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia facial, Paraesthesia, Pharyngeal hypoaesthesia
Clinical narrative: Initial case was received on 11 June 2010 from a healthcare professional. A 44 year old male patient received a left arm intramuscular injection of ADACEL (lot number C3475AA) at 3:15 p.m. on 08 June 2010. At 4:48 p.m. on 08 June 2010 he experienced lightheadedness and numbness on the face. The patient had no illness at the time of the vaccination. He had no pre-existing medical conditions and no known allergies. There were no reported adverse events to prior vaccinations. The patient went to the emergency room (ER) and was treated with BENADRYL. At the time of this report it was unknown if the patient had recovered. Follow-up information was received on 17 June 2010 from a healthcare professional (who received information from the patient). Upon receipt of this information it was determined that the case meets seriousness criteria, and it has been upgraded to serious. After receiving the ADACEL vaccination on 08 June 2010 the patient waited 30 minutes as advised by the pharmacist. On his way home he began feeling lightheaded and a numb, tingling sensation on his right side from the cheek, down his arm to his hand. He felt that he might pass out. Upon arriving home, he laid down, began feeling worse and the numbness moved across his chest and throat. His chest felt tight and he had difficulty breathing. He was seen in the emergency room and the doctor told him he was having an allergic reaction. He was advised in the emergency room to "avoid tetanus shots in the future." The patient's treatment included Albuterol HFA oral inhaler 2 puffs each 6 hours for 1 week, prednisone 20 mg 3 orally every day for 5 days and BENADRYL 25 mg 2 every 6 hours as needed. The patient was to follow-up with his physician within two days. As of 16 June 2010, the patient still had some numbness on the right side of his face. Follow-up information received on 19 July 2010 from a pharmacist. The reporter tried on two different occasions to contact the patient to obtain further information regarding this case and the patient has not returned the phone calls. The reporter contacted the patient's primary care physician and was told the patient had not contacted them either. Documents held by sender: None.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Loss of consciousness, Pyrexia
Clinical narrative: Initial report was received 26 July 2010 from a health care professional. A 55-year-old female patient had received an intramuscular right deltoid injection of ADACEL, lot number U3082AA on 06 July 2010 and four days later, she "blacked out" for two minutes, experienced a fever (temperature not recorded), and developed redness, swelling and blistering at the injection site. The events did not require medical intervention and the patient self medicated with unspecified pain killers. The patient was evaluated on 26 July 2010 (results not reported). The patient had last received a TD vaccination greater than 10 years ago and she had no illness at the time of vaccination. She had a past history of GERD (gastroesophageal reflux disease), low back pain, htn (hypertension), osteoporosis, "hyperlipidemia", insomnia and anxiety and she had been taking HCTZ, hydrococone, zanax, lopressor, lisinopril, boniva, nystat, previcid, "symbastatin" and ambien concomitantly. According to the reporter, the patient recovered. Follow-up information received from a health care professional on 07 September 2010. Patient information and responsible physician name were provided. No other relevant medically significant information was provided. Documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site reaction, Injection site swelling
Clinical narrative: Initial report received from a health care professional on 27 July 2010. An unknown patient had received a dose of ADACEL (lot number, route and site not reported) on an unspecified date. At an unspecified amount of time later, the patient experienced site reactions/excessive swelling on the injection site. No other information was provided. Recovery status was not reported. Follow-up information was received on 16 September 2010 from a health care professional. The patient was identified as a 65 year-old female who had received an intramuscular left deltoid injection of ADACEL, lot number C3487AA on 16 July 2010. On 18 July 2010 the patient experienced on her left upper arm a red, warm four inch size area with a small hard lump in the middle. No further information was available at the time of the report. The patient's outcome was reported as recovered (date not provided). Follow-up information was received from the healthcare professional on 22 November 2010. The patient was not ill at the time of vaccination, was not taking any concomitant medications, and had not received any other vaccines within 4 weeks of the event. Per the reporter, no additional information was available. Documents held by sender: VAERS.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: Initial report received from a health care professional on 27 July 2010. An unknown patient had received a dose of ADACEL (lot number, route and site not reported) on an unspecified date. At an unspecified amount of time later, the patient experienced site reactions/excessive swelling on the injection site. No other information was provided. Recovery status was not reported. Follow-up information was received on 16 September 2010 from a health care professional. The patient was identified as a 65 year-old female who had received an intramuscular left deltoid injection of ADACEL, lot number C3487AA on 16 July 2010. On 18 July 2010 the patient experienced on her left upper arm a red, warm four inch size area with a small hard lump in the middle. No further information was available at the time of the report. The patient's outcome was reported as recovered (date not provided). Follow-up information was received from the healthcare professional on 22 November 2010. The patient was not ill at the time of vaccination, was not taking any concomitant medications, and had not received any other vaccines within 4 weeks of the event. Per the reporter, no additional information was available. Documents held by sender: VAERS.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Injection site pain
Clinical narrative: Initial report was received 29 July 2010 from a health care professional. A 26-year-old female patient had received an intramuscular left deltoid injection of ADACEL, lot number U3082AA (sanofi pasteur Ltd lot number C3314) on 30 June 2010, and "since the date of vaccination", she experienced soreness at the left deltoid. There was no redness or swelling. At the time of the report, outcome was not recovered. Follow-up information was received 27 August 2010 from a health care professional. Based upon new  information received, it was determined this case meets seriousness criteria, and this case has been upgraded from non-serious to serious. According to the reporter, the patient continued to experience discomfort and was currently in physical therapy. No additional information was provided at the time of the report. Follow-up information was received from a health care professional on 29 October 2010 reported that the patient had no illness at the time of vaccination and was otherwise healthy. The patient had no history of injury to the shoulder. The ADACEL was indicated for a routine TDAP booster. No additional information was available at this time. This report involved one patient out of a cluster of two previously unidentified patients who experienced similar events. The other patient has been captured in case number 2010-03852. Follow-up information received from a physician on 06 December 2010. The case was reviewed by the reporter and there was no additional information available. Follow-up information was received 28 December 2010 from a health care professional. The reporter stated that the patient had not been evaluated in their office since 12 July 2010, so they presumed the event had resolved. No further information was provided. Follow-up information was received on 28 January 2011 from a health care professional. Patient demographic information was provided. No new medical information was reported. Documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site oedema, Injection site pain
Clinical narrative: Initial case was received on 13 September 2010 from a healthcare professional. A 26 year old female patient received on 01 September 2010, at left deltoid intramuscular injection of ADACEL (lot number C3448AA). She was seen at student health service on 03 September 2010 with a history of 24 hours of edema, erythema, and tenderness at the site of administration. Treatment included BENADRYL 25 mg by mouth (po) every 6 hours (q6) as needed (prn), ibuprofen 400 mg po three times a day (TID) prn and ice applied to site. The patient was seen again on 13 September 2010 and the left deltoid vaccination site was "2 cm, discolored yellowish, healing ecchymosis." The patient continued to take BENADRYL twice daily and started taking ADVIL for the tenderness at the vaccination site and applied ice. The patient had no illness at the time of the vaccination. Her medical history included a VICODIN allergy and seasonal allergies. Concomitant medications included ORTHOTRICYCLEN, VALTREX, ZOLOFT and multivitamin. The patient had no adverse event following prior vaccination. As of this report the patient was recovering. Follow-up information was received from a health care professional on 29 October 2010. The onset date for the event ecchymosis at the vaccination site was reported as 02 September 2010. The patient was last seen at the health center on the 13 September 2010 at which time she was fully recovered. The patient was informed to return if any symptoms returned. No further information was available. The outcome was reported as recovered. Follow-up information was received from a health care professional on 02 November 2010 reported that the patient's adverse event resolved on 17 September 2010 (previously reported as 13 September 2010). Documents held by sender: None.
Age: 32.0
Sex: M
Vaccine: SMALL, TDAP
Symptoms: Cellulitis, Full blood count, Impaired healing, Skin lesion, Vaccination complication
Clinical narrative: This case was received on 09 December 2010 via a QScan search on the VAERS database, under reference number 399501. A 32-year-old male patient received the following vaccinations on 08 September 2010: a percutaneous ACAM2000 (lot number VV04003A) and ADACEL, lot number C3486AA. The patient has a history of hypertension and takes hydrochlorothiazide (HCTZ). He has an allergy to penicillin. On 17 September 2010, the patient developed cellulitis (reported per VAERS), impaired healing and vaccination complication. The patient required an emergency visit where a complete blood count was performed (results not reported). The patient's smallpox (SM) vaccine site was healing with no discharge or signs of cellulitis noted. The satellite lesion was healing without signs of cellulitis. The outcome was reported as unknown. Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Feeling hot, Inflammation, Limb immobilisation, Muscular weakness
Clinical narrative: Initial report was received from a consumer who is also the patient on 29 October 2010. A 56 year-old female with a history of left breast cancer, right hand pain and weakness with overuse and allergies to penicillin (PCN), morphine and thimerosal, had received a first dose intramuscular right deltoid injection of ADACEL (lot number not reported) and an intradermal right forearm injection of TUBERSOL 5 TU (lot number not reported) on 13 October 2010 and "three days later", experienced pain in both her thumb joints. She reported her left thumb pain has decreased by "75%" however her right thumb pain continues and is also stiff and weak. No further information was available at the time of the report. The patient's out was not recovered. Follow-up information received from a health care professional on 13 January 2011 reported that the patient had no illness at the time of vaccination. The patient had received greater than 16 previous doses of TUBERSOL in the past. The patient had a sensitivity reaction to the (dose 1) H1N1 vaccine, CSL O0249611A at age 56-years. The patient received ADACEL, sanofi pasteur Ltd. lot number C3448AA and TUBERSOL 5 TU, sanofi pasteur Ltd. lot number C3510AA. On 16 October 2010, the patient developed bilateral thumb joints that were very painful, hot, inflamed and difficult to move. She began taking NSAIDs with minimal pain relief and continued taking NSAIDS throughout the week. On 26 October 2010, she reported to the Occupational Health nurse via phone that her pain in the left thumb joint began to subside somewhat but had no change in the right thumb joint. On 29 October 2010, the patient spoke with a representative of sanofi pasteur that stated that "underlying conditions can experience a "flare-up" from ADACEL." On the 12 November 2010, the patient updated the Occupational Health Service (OHS) via e-mail. The patient was treated with NAPROSYN, and started using a thumb immobilizer on 13 November 2010. She also received occupational therapy (OT). The patient has been wearing the thumb immobilizer around the clock except to shower with no improvement noted in the right thumb joint. The left thumb joint has become aggravated from increased use. The etiology of the event was reported as unknown and adverse reaction. The diagnosis was "tenosynovitis secondary to T-DAP vac". The patient has not recovered and remains under medical care. Follow-up information was received from the health care professional on 16 March 2011. Since reporting the adverse event, the patient had 5 appointments with an occupational physician, and had 12 occupational therapy sessions. She continued to use keneiso tape to help alleviate tenosynovitis in her right thumb and hand. Her last therapy session was 23 February 2011, and last doctor's appointment was 01 March 2011; no further appointments were scheduled. No diagnostic test were ordered. The event was still ongoing at the time of the report. Documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pain in extremity, Tenosynovitis
Clinical narrative: Initial report was received from a consumer who is also the patient on 29 October 2010. A 56 year-old female with a history of left breast cancer, right hand pain and weakness with overuse and allergies to penicillin (PCN), morphine and thimerosal, had received a first dose intramuscular right deltoid injection of ADACEL (lot number not reported) and an intradermal right forearm injection of TUBERSOL 5 TU (lot number not reported) on 13 October 2010 and "three days later", experienced pain in both her thumb joints. She reported her left thumb pain has decreased by "75%" however her right thumb pain continues and is also stiff and weak. No further information was available at the time of the report. The patient's out was not recovered. Follow-up information received from a health care professional on 13 January 2011 reported that the patient had no illness at the time of vaccination. The patient had received greater than 16 previous doses of TUBERSOL in the past. The patient had a sensitivity reaction to the (dose 1) H1N1 vaccine, CSL O0249611A at age 56-years. The patient received ADACEL, sanofi pasteur Ltd. lot number C3448AA and TUBERSOL 5 TU, sanofi pasteur Ltd. lot number C3510AA. On 16 October 2010, the patient developed bilateral thumb joints that were very painful, hot, inflamed and difficult to move. She began taking NSAIDs with minimal pain relief and continued taking NSAIDS throughout the week. On 26 October 2010, she reported to the Occupational Health nurse via phone that her pain in the left thumb joint began to subside somewhat but had no change in the right thumb joint. On 29 October 2010, the patient spoke with a representative of sanofi pasteur that stated that "underlying conditions can experience a "flare-up" from ADACEL." On the 12 November 2010, the patient updated the Occupational Health Service (OHS) via e-mail. The patient was treated with NAPROSYN, and started using a thumb immobilizer on 13 November 2010. She also received occupational therapy (OT). The patient has been wearing the thumb immobilizer around the clock except to shower with no improvement noted in the right thumb joint. The left thumb joint has become aggravated from increased use. The etiology of the event was reported as unknown and adverse reaction. The diagnosis was "tenosynovitis secondary to T-DAP vac". The patient has not recovered and remains under medical care. Follow-up information was received from the health care professional on 16 March 2011. Since reporting the adverse event, the patient had 5 appointments with an occupational physician, and had 12 occupational therapy sessions. She continued to use keneiso tape to help alleviate tenosynovitis in her right thumb and hand. Her last therapy session was 23 February 2011, and last doctor's appointment was 01 March 2011; no further appointments were scheduled. No diagnostic test were ordered. The event was still ongoing at the time of the report. Documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bordetella test, Bordetella test positive, Cough, Pertussis, Productive cough
Clinical narrative: Initial report was received from a health care professional on 24 January 2011. A 13 year-old patient with no reported past medical history, had received ADACEL, lot number U3051CA (sanofi pasteur Ltd lot number CC3312, route and site of administration not reported) on 14 July 2010 and approximately six months later on 18 January 2011, had a positive B pertussis IgM Ab of 1.3 (minimal and maximum values that establish the normal range were not reported). No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received on 07 March 2011 from a health care professional who provided the normal range values of B pertussis IgM Ab which were a negative of less than 1.0 and a positive of greater than 1.1. The patient's B pertussis IgM Ab was 1.3. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious. The female patient who had no reported illness at the time of vaccination, had received a left deltoid injection of ADACEL on 14 July 2010. She presented with a persistent productive cough for six weeks on 10 January 2011. She had a confirmed positive B pertussis IgM Ab result on 18 January 2011. She was treated with Cefdinir, MYTUSSIN AC, Prednisone and Fluticasone. Concomitant medications were listed as none. Her vaccine history included: Five doses of DTaP (30/Jun/1997, 15/Aug/1997, 29/Oct/1997, 01/May/1998, 23/Jul/2002); Four doses of OPV or IPV (30/Jun/1997, 15/Aug/1997, 29/Oct/1997, 23/Jul/2002); Two doses of MMR (01/May/1998, 23/Jul/2002); Four doses of HIB (30/Jun/1997, 15/Aug/1997, 29/Oct/1997, 01/May/1998); Three doses of Hepatitis B (28/Apr/1997, 30/Jun/1997, 29/Oct/1997) and a dose of Varicella (01/May/1998). No further information was provided at the time of this report. The patient's outcome was reported as recovered. Follow-up information was received on 04 April 2011 from a health care professional. Lot numbers were provided for the five doses of DTaP as follows: TRIPEDIA dose one, lot number 6K71127; TRIPEDIA dose two, lot number 6F81445; TRIPEDIA dose three, lot number 7L81673; TRIPEDIA dose four, lot number 7G81491 and dose five, lot number APC3474AA. Route was not reported. The patient was "ok" to return to school on 27 January 2011. No further information was provided at the time of the report. Follow-up information was received 22 April 2011 from a health care professional who provided a copy of the patient's ADACEL immunization report. The reporter confirmed that ADACEL had been administered as an intramuscular 0.5 mL dose. No additional information was provided. Documents held by sender: Immunization report.
Age: 32.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Axillary pain, Lymph node pain, Lymphadenopathy, Oedema peripheral
Clinical narrative: Initial report was received on 18 February 2011 from a consumer, who is also the patient. A 32 year-old female patient with a history of high blood pressure, hyperthyroidism and allergies to morphine and iodine had received a right arm injection of ADACEL (lot number and route of administration not reported) on 16 February 2011 and experienced that day, soreness at injection site and throbbing, soreness in the arm pit. Treatments included MOTRIN. Concomitant medications were COREG, LOESTRIN, LEXAPRO, SYNTHROID, Fish oil and multivitamins. The patient had no illness at the time of vaccination. No further information was available at the time of the report. The patient's outcome was unknown. Follow-up information was received from a health care professional on 05 April 2011. The patient's pain and swelling started on 17 February 2011 (previously reported on 16 February 2011. It was confirmed that the patient took MOTRIN and everything resolved on 20 February 2011. The patient received the ADACEL intramuscularly. The outcome was reported as recovered. Follow-up information was received from a health care professional on 03 May 2011. The patient received ADACEL, lot number U2969AA (sanofi pasteur ltd. lot number C3171). No further information was provided at the time of the report. The patient's outcome remained recovered. Documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Axillary pain, Injection site pain, Pain, Swelling
Clinical narrative: Initial report was received on 18 February 2011 from a consumer, who is also the patient. A 32 year-old female patient with a history of high blood pressure, hyperthyroidism and allergies to morphine and iodine had received a right arm injection of ADACEL (lot number and route of administration not reported) on 16 February 2011 and experienced that day, soreness at injection site and throbbing, soreness in the arm pit. Treatments included MOTRIN. Concomitant medications were COREG, LOESTRIN, LEXAPRO, SYNTHROID, Fish oil and multivitamins. The patient had no illness at the time of vaccination. No further information was available at the time of the report. The patient's outcome was unknown. Follow-up information was received from a health care professional on 05 April 2011. The patient's pain and swelling started on 17 February 2011 (previously reported on 16 February 2011. It was confirmed that the patient took MOTRIN and everything resolved on 20 February 2011. The patient received the ADACEL intramuscularly. The outcome was reported as recovered. Follow-up information was received from a health care professional on 03 May 2011. The patient received ADACEL, lot number U2969AA (sanofi pasteur ltd. lot number C3171). No further information was provided at the time of the report. The patient's outcome remained recovered. Documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: Initial report was received 31 March 2011 from a health care professional, who also reported the event to VAERS (temporary VAERS E-Report Number: not reported). This report contains information for one patient, out of a cluster of two patients, who experienced adverse events after receiving ADACEL, lot number C3540AA. A 36-year-old female patient who had a history of penicillin allergy and who was two days post vaginal delivery of a full term infant, had received an intramuscular right deltoid injection of ADACEL, lot number C3540AA and an intramuscular left deltoid injection of FLUVIRIN (manufacturer Novartis, lot number 111694) on 16 February 2011 at 10:00 AM. An unspecified amount of time later, the patient developed migratory pain from the deltoid (right or left not specified) to the trapezius muscle. The patient also complained of right arm soreness and pain whenever she moved the arm, and arm weakness. There was no redness or nodule noted at the right deltoid injection site. The patient reported these symptoms to her health care provider during a follow-up visit on 31 March 2011. Laboratory and diagnostic testing had not been performed. The patient had no concurrent illness at the time of vaccination and she not received any other vaccines within four weeks of ADACEL and FLUVIRIN. She had not experienced any adverse events following prior vaccinations. Concomitant medications consisted of AMBIEN. According to the reporter, the patient had not recovered. Follow-up information was received from the healthcare professional on 09 May 2011. The patient recovered on an unspecified date. Per the reporter, no additional information was available at this time. The reporter for this case is the same as for case number 2011-02010. Documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Injection site pain, Muscular weakness, Myalgia, Pain, Pain in extremity
Clinical narrative: Initial report was received 31 March 2011 from a health care professional, who also reported the event to VAERS (temporary VAERS E-Report Number: not reported). This report contains information for one patient, out of a cluster of two patients, who experienced adverse events after receiving ADACEL, lot number C3540AA. A 36-year-old female patient who had a history of penicillin allergy and who was two days post vaginal delivery of a full term infant, had received an intramuscular right deltoid injection of ADACEL, lot number C3540AA and an intramuscular left deltoid injection of FLUVIRIN (manufacturer Novartis, lot number 111694) on 16 February 2011 at 10:00 AM. An unspecified amount of time later, the patient developed migratory pain from the deltoid (right or left not specified) to the trapezius muscle. The patient also complained of right arm soreness and pain whenever she moved the arm, and arm weakness. There was no redness or nodule noted at the right deltoid injection site. The patient reported these symptoms to her health care provider during a follow-up visit on 31 March 2011. Laboratory and diagnostic testing had not been performed. The patient had no concurrent illness at the time of vaccination and she not received any other vaccines within four weeks of ADACEL and FLUVIRIN. She had not experienced any adverse events following prior vaccinations. Concomitant medications consisted of AMBIEN. According to the reporter, the patient had not recovered. Follow-up information was received from the healthcare professional on 09 May 2011. The patient recovered on an unspecified date. Per the reporter, no additional information was available at this time. The reporter for this case is the same as for case number 2011-02010. Documents held by sender: none.