chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Feeling abnormal, Headache, Malaise
Clinical narrative: By 3:00pm. 10/7/10 pt began to feel a pressure on her chest & her throat felt thick. By 500pm. headache, fever, chills, body aches & scratchy throat - felt terrible all night till Fri. AM. Headache lingered & didn't feel well all Fri but felt better on Sat 10/9/10.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Throat irritation, Throat tightness
Clinical narrative: By 3:00pm. 10/7/10 pt began to feel a pressure on her chest & her throat felt thick. By 500pm. headache, fever, chills, body aches & scratchy throat - felt terrible all night till Fri. AM. Headache lingered & didn't feel well all Fri but felt better on Sat 10/9/10.
Age: 16.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4
Symptoms: Dry skin, Skin warm, Syncope, Unresponsive to stimuli
Clinical narrative: Pt received GARDASIL #3 - HepA #1 FLUMIST. At about 10 m. after immunization, pt developed a syncopal episode became unresponsive for about 2 m. placed on supine position skin warm & dry. BP 113/66 Pulse 82. Resp non labored. Pulse Ox 98% BS 90 mg/dl. after stimulation became responsive about 3:50 PM.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash to chest.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: Hives - generalized, pruritis, shortness of breath CLARITIN Steroids - SOLU-MEDROL then SOLU-MEDROL dose pack BENADRYL topical steroid cream.
Age: 23.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Redness to upper arm, warm to touch. Pt c/o redness since 19 Nov 10. Pt prescribed KEFLEX for cellulitis on 22 Nov 10.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Injection site discolouration, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: Patient reported severe swelling, skin discoloration, bruising with some pain in the inner aspect of the left upper arm extending the entire length of the arm. Reaction by history started approximately 48 hrs post vaccination. By patient history, the injection site was minimally involved. Patient was seen by his primary care physician who diagnosed the reaction as a response to the vaccine by patient's history.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain in extremity, Skin discolouration, Vaccination complication
Clinical narrative: Patient reported severe swelling, skin discoloration, bruising with some pain in the inner aspect of the left upper arm extending the entire length of the arm. Reaction by history started approximately 48 hrs post vaccination. By patient history, the injection site was minimally involved. Patient was seen by his primary care physician who diagnosed the reaction as a response to the vaccine by patient's history.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site discolouration, Injection site erythema, Injection site haemorrhage, Injection site pain
Clinical narrative: Left deltoid redness & pain noted 36 hrs after influenza vaccine administration; no fever; puncture site has scab & surrounding green hue or ecchymosis; beneath ecchymosis is a 5cm x 4cm red, warm, nontender patch.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site scab, Skin warm
Clinical narrative: Left deltoid redness & pain noted 36 hrs after influenza vaccine administration; no fever; puncture site has scab & surrounding green hue or ecchymosis; beneath ecchymosis is a 5cm x 4cm red, warm, nontender patch.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Pyrexia, Sleep disorder
Clinical narrative: Two days after Flu shot I came down with a fever. Then I got a severe cough. I had trouble breathing. My doctor had me get cough medicine and Azithromycin 250mg tablets 6 pak. After ten days I still was very sick so my doctor renewed my Azithromycin for another 10 days. This was on 10-21-10. On Nov 8th I went back to the doctor and she ordered a stronger antibiotic and cough medicine. On Nov 8th I started taking Amoxicillin 250mg capsules, this antibiotic did help me a little. It is now Nov 21st and I still have a cough. Since Oct. 2nd I have never been able to sleep all night. I wake up every 1 to 2 hours coughing and I have to get up and get a drink and cough drops. In all my life I have had many flu shots and never got sick. After this I will never get another flu shot.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Dysphonia, Dyspnoea, Eye discharge, Ocular hyperaemia
Clinical narrative: 3 hrs after shot, sore, throat, hoarse voice, tight feeling in neck, increased effort to swallow, white of eyes became redden and thick white drainage from both eyes. Increased difficulty breathing. Events occurred 11/2/2010.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Skin tightness
Clinical narrative: 3 hrs after shot, sore, throat, hoarse voice, tight feeling in neck, increased effort to swallow, white of eyes became redden and thick white drainage from both eyes. Increased difficulty breathing. Events occurred 11/2/2010.
Age: 91.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Swelling in arm, hands, fingers 1-2 days after she received shot lasted about 1 week.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Body temperature increased, Chills, Disorientation
Clinical narrative: Awoke w/terrible thirst - lasted approx 4 hrs developed chills w/temp 102 - aches and pains in legs and back. Very weak and disoriented - treatment Aspirin - lasted 24 hrs.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Thirst
Clinical narrative: Awoke w/terrible thirst - lasted approx 4 hrs developed chills w/temp 102 - aches and pains in legs and back. Very weak and disoriented - treatment Aspirin - lasted 24 hrs.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Fall, Rhinorrhoea, Staring, Unresponsive to stimuli
Clinical narrative: Initial report received from a health care professional on 22 November 2010. A 4-year-old child, with a medical history of respiratory infections, ear infections and a urinary abnormality which required surgery, received on 01 November 2010 a right deltoid intramuscular injection of FLUZONE, lot number U3743AA. The patient's concomitant medications included albuterol PRN, permethrin 1% shampoo, and MIRALAX. The patient had no illness at the time of vaccination and no other vaccinations within 4 weeks of FLUZONE. The patient had received several previous doses of flu vaccine. On 17 November 2010, the patient developed sniffles, an episode of staring and did not respond. He then crumpled to the floor and did not respond which lasted 30 minutes before he became himself again. The patient was taken to the Emergency Room (ER) where a computed tomography (CT) scan was performed and showed normal. The patient was hospitalized and kept overnight where no further episodes or symptoms were observed. The patient had used permethrin 1% shampoo (date and time not reported). The outcome was reported). The outcome was reported as recovered on 22 November 2010. Documents held by sender: None.
Age: 9.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pruritus, Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Initial report received from a health care professional on 23 November 2010. A 9-year-old female child received on 16 November 2010 at approximately 9:30 AM a 0.5 milliliter left deltoid intramuscular injection of FLUZONE SV, lot number U3744AA. The patient had no medical history and took no concomitant medications. She had no illness at the time of vaccination, no allergy to eggs and had no other vaccinations within 4 weeks of the FLUZONE. The patient had previously received in 2008 the flu vaccine and 2009-2010 the H1N1 vaccine. On the 17 November 2010 around 3:00 AM, the patient woke with hives and itching on the left arm injection site, trunk and legs. On 17 November 2010 the patient was taken to the Emergency Department (ED) where she received treatment with prednisone and BENADRYL. She was discharged from the ED with prescriptions for prednisone for 3 days, PEPCID for one week and diphenhydramine as needed. The patient returned to the ED on 18 November 2010 with itching and transient hives seen over body. She had no respiratory difficulty. The patient had started prednisone 10 milligrams (mg) on the 17 November 2010 and was given one dose in the AM on the 18 November 2010 as well as diphenhydramine. In the ED she had raised urticaria over entire body except for the face with some wheels in the form of hives which were widely distributed over the trunk and extremities. The patient was treated with 20 mg of prednisone, diphenhydramine and famotidine. She was discharged from the ED. On 22 November 2010 the patient was seen by her primary physician where her hives were noted as resolved. The physician was to speak with an allergist due to no clear etiology for the rash other the vaccine. The outcome was reported as recovered. Documents held by sender: None.
Age: 9.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Initial report received from a health care professional on 23 November 2010. A 9-year-old female child received on 16 November 2010 at approximately 9:30 AM a 0.5 milliliter left deltoid intramuscular injection of FLUZONE SV, lot number U3744AA. The patient had no medical history and took no concomitant medications. She had no illness at the time of vaccination, no allergy to eggs and had no other vaccinations within 4 weeks of the FLUZONE. The patient had previously received in 2008 the flu vaccine and 2009-2010 the H1N1 vaccine. On the 17 November 2010 around 3:00 AM, the patient woke with hives and itching on the left arm injection site, trunk and legs. On 17 November 2010 the patient was taken to the Emergency Department (ED) where she received treatment with prednisone and BENADRYL. She was discharged from the ED with prescriptions for prednisone for 3 days, PEPCID for one week and diphenhydramine as needed. The patient returned to the ED on 18 November 2010 with itching and transient hives seen over body. She had no respiratory difficulty. The patient had started prednisone 10 milligrams (mg) on the 17 November 2010 and was given one dose in the AM on the 18 November 2010 as well as diphenhydramine. In the ED she had raised urticaria over entire body except for the face with some wheels in the form of hives which were widely distributed over the trunk and extremities. The patient was treated with 20 mg of prednisone, diphenhydramine and famotidine. She was discharged from the ED. On 22 November 2010 the patient was seen by her primary physician where her hives were noted as resolved. The physician was to speak with an allergist due to no clear etiology for the rash other the vaccine. The outcome was reported as recovered. Documents held by sender: None.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site haematoma, Injection site induration
Clinical narrative: Bruising & redness to (R) upper arm at injection site with approx. 3.5 x 4cm induration. Oral antibiotics by PCP.
Age: 22.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Pt. presented with nausea and dizziness at 1310 taken to exam rm. Vital signs obtained. Doctor called to evaluate pt. Pt. was treated with O2, Epi, and BENADRYL. Pt. released to ambulance services, transported to hospital.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Son called and stated that his father had a seizure after receiving a flu vaccination. Son stated that father transported to ER by ambulance & is ok now.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Drug hypersensitivity, Pruritus
Clinical narrative: Pruritis - no rash - Prednisone taper, 3 day - 2 day. ALLEGRA 100mg, ATARAX 25mg.
Age: 0.58
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dysphonia, Dyspnoea, Heart rate increased, Pain
Clinical narrative: Patient experienced the following symptoms: paleness, chills, full body hives, vomiting, difficulty breathing, hoarseness/wheezing, 102.4 fever that wouldn't break, and rapid heartbeat. Also severe body aches and pains.
Age: 0.58
Sex: F
Vaccine: FLU3
Symptoms: Pallor, Pyrexia, Urticaria, Vomiting, Wheezing
Clinical narrative: Patient experienced the following symptoms: paleness, chills, full body hives, vomiting, difficulty breathing, hoarseness/wheezing, 102.4 fever that wouldn't break, and rapid heartbeat. Also severe body aches and pains.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Autism spectrum disorder, Cough, Developmental delay, Eyelid oedema, Pyrexia
Clinical narrative: High fever, cough, small red bumps all over her entire body and then turned into large whelps all over. then her right eye swelled shut.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Rash erythematous, Speech disorder, Urticaria
Clinical narrative: High fever, cough, small red bumps all over her entire body and then turned into large whelps all over. then her right eye swelled shut.
Age: 63.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms ache all over slight fever. All subsided after 12 hours then 12 hours later fever spiked and aches returned with vengence. On and off for 4 days now.
Age: 63.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Flu like symptoms ache all over slight fever. All subsided after 12 hours then 12 hours later fever spiked and aches returned with vengence. On and off for 4 days now.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: The patients mother states that the child care center called her to pick up the patient due to multiple patches of hives and rashes on his body. Hives are visible on legs, arms, torso, face.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: 2 days after flu shot was administered patient developed hives on chest, stomach and back. Pt has had flu shots before and also took MUCINEX during this time.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: Morning after receiving vaccination pt reported waking with extremely swollen face and widespread, itchy hives over arms, trunk, and more. Sought medical tmt, rec'd steroids and antihistamines.
Age: 3.0
Sex: F
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Blood immunoglobulin E, Injection site erythema, Injection site swelling
Clinical narrative: Bilateral erythema swelling 2 cm (L) arm 3 cm (R) arm.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Stated severe pain at site and surrounding area, lasting more than 24 hours. Used TYLENOL, VICODIN and ice.
Age: 1.41
Sex: U
Vaccine: FLU3, MMR, PNC13
Symptoms: Pyrexia, Rash generalised, Vomiting
Clinical narrative: Patient developed fever, vomiting, broke out in rash all over the body.
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Headache
Clinical narrative: Initial report received from a consumer on 17 November 2010. A female patient, with a birth date of 15 January 1952, received on an unknown date in 2009 (reported as last year) an injection site (route and site not reported) of INFLUENZA VACCINE, lot number not reported. The patient had a history of shingles and has had ongoing neuralgia. She had no illness at the time of vaccination and received a shingles vaccine prior to the FLUZONE but did not know how long before receiving flu vaccine. The patient's concomitant medications were unknown. On an unknown date last year, the patient developed breathing difficulty, headache, and extreme tiredness for at least three months after the vaccination. The patient was seen by a physician for treatment. The patient reported that the doctor did not think the reactions were related to last year's (2009) flu vaccine. The outcome was reported as recovered. Documents held by sender: None.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Itchiness, redness, hives for about 1 1/2 wks. All symptoms were around the area of the vaccination. Hive started 24 hours after injection.
Age: 7.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 11/21/10 2:20 PM Large erythematous, warm, indurated area surrounding where 2 immunizations given 11/19/10. Pt was seen in ED and given 1 dose of KEFLEX. Cephalexin 250 mg/5 ml, 7 1/2 ml every 12 hrs x 5 days ordered 11/21/10.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Instant extreme redness, about 6 inches long and all across my arm, heat, pain, swelling, redness lasted almost 2 weeks with gradual fading after about 8 days. It still hurts occasionally now. I have never had any problems in the past. I don't know if I will get again it still hurts. ODD.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenopia, Conjunctivitis allergic, Diplopia, Eyelid oedema, Fundoscopy normal
Clinical narrative: Initial report received on 18 November 2010 from a physician, who is also the patient. A 58-year-old female patient received an influenza vaccine in mid-October 2010 (exact date of vaccination, manufacturer, and lot number not reported). She had a history of well-controlled hypertension. On 04 November 2010, while outside, she reported that her eyes "felt heavy". Her husband, who was also a physician, noted that her eyelids were swollen and felt that she might be suffering from an allergy to grass. The following day the patient reported diplopia while driving, and was evaluated by an opthamologist. Visual acuity and fundoscopic exam were normal, and she was diagnosed with allergic conjunctivitis. She was seen by another opthamologist the next day, and was prescribed steroid drops. She consulted a neurologist, who thought that she might have cranial nerve involvement; however, an MRI was normal. At the time of the report, the symptoms had completely resolved. Additional documents held by sender: None.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging normal, Visual acuity tests normal
Clinical narrative: Initial report received on 18 November 2010 from a physician, who is also the patient. A 58-year-old female patient received an influenza vaccine in mid-October 2010 (exact date of vaccination, manufacturer, and lot number not reported). She had a history of well-controlled hypertension. On 04 November 2010, while outside, she reported that her eyes "felt heavy". Her husband, who was also a physician, noted that her eyelids were swollen and felt that she might be suffering from an allergy to grass. The following day the patient reported diplopia while driving, and was evaluated by an opthamologist. Visual acuity and fundoscopic exam were normal, and she was diagnosed with allergic conjunctivitis. She was seen by another opthamologist the next day, and was prescribed steroid drops. She consulted a neurologist, who thought that she might have cranial nerve involvement; however, an MRI was normal. At the time of the report, the symptoms had completely resolved. Additional documents held by sender: None.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Axillary pain, Breast pain, Pain in extremity
Clinical narrative: On November 12 around noon, I received the flu shot in left arm and the next day I began to experience pain in armpit traveling to breast and down arm. Pain lasted til 11-19.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, No reaction on previous exposure to drug
Clinical narrative: Initial report received on 17 November 2010 from an investigator participating in a trial. A 5-year-old male subject (initials not collected), who had received a 0.25 mL injection of flu vaccine (trade name, manufacturer name, and lot number not reported) in 2005 with no problems, experienced accentuated injection-site reaction 17:16 hours after receiving a first intramuscular left deltoid injection of either, INFLUENZA VIRUS VACC QUAD A & B, or INFLUENZA VIRUS VACC NO PRESERV. TRIVAL A&B SV-U ALT-B, or FLUZONE No Preservative 2010-2011 on 11 November 2010. The lot number of the administered product was not reported. The subject's left arm from the elbow to the shoulder had severe swelling (that stopped on 16 November 2010), redness, hardness and was hot to touch the morning following vaccination. The subject was seen in the emergency room and diagnosed with allergic reaction to vaccine. Corrective treatment included BENADRYL prn, and KEFLEX for 10 days. The subject has not recovered. According to the investigator the event was related to the study vaccine, but not to the trial procedures. The investigator considered the event to be an "Other: important medical event" specified as: severe injection site swelling, redness, hardness and hot to the touch and the subject was seen at the emergency room and diagnosed with allergic reaction and treated with BENADRYL and cefalexin. The serious adverse event lead to the subject's termination from the clinical trial. Documents held by sender: None. Medical assessment: Transient severe local injection site reactions are expected after administration of different formulations of FLUZONE vaccine. The Investigator has not provided a final diagnosis, injection site reaction versus allergic reaction. Treatment with steroid was not required implying it was not a severe reaction. Also antibiotics were prescribed for treatments of the event, indicating some infectious process was suspected. It is not known if any diagnostics were performed to confirm or support the tentative diagnosis. Though a possible relation with vaccination is possible, more information will be requested to fully assess the case/make a causality assessment.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Initial report received on 17 November 2010 from an investigator participating in a trial. A 5-year-old male subject (initials not collected), who had received a 0.25 mL injection of flu vaccine (trade name, manufacturer name, and lot number not reported) in 2005 with no problems, experienced accentuated injection-site reaction 17:16 hours after receiving a first intramuscular left deltoid injection of either, INFLUENZA VIRUS VACC QUAD A & B, or INFLUENZA VIRUS VACC NO PRESERV. TRIVAL A&B SV-U ALT-B, or FLUZONE No Preservative 2010-2011 on 11 November 2010. The lot number of the administered product was not reported. The subject's left arm from the elbow to the shoulder had severe swelling (that stopped on 16 November 2010), redness, hardness and was hot to touch the morning following vaccination. The subject was seen in the emergency room and diagnosed with allergic reaction to vaccine. Corrective treatment included BENADRYL prn, and KEFLEX for 10 days. The subject has not recovered. According to the investigator the event was related to the study vaccine, but not to the trial procedures. The investigator considered the event to be an "Other: important medical event" specified as: severe injection site swelling, redness, hardness and hot to the touch and the subject was seen at the emergency room and diagnosed with allergic reaction and treated with BENADRYL and cefalexin. The serious adverse event lead to the subject's termination from the clinical trial. Documents held by sender: None. Medical assessment: Transient severe local injection site reactions are expected after administration of different formulations of FLUZONE vaccine. The Investigator has not provided a final diagnosis, injection site reaction versus allergic reaction. Treatment with steroid was not required implying it was not a severe reaction. Also antibiotics were prescribed for treatments of the event, indicating some infectious process was suspected. It is not known if any diagnostics were performed to confirm or support the tentative diagnosis. Though a possible relation with vaccination is possible, more information will be requested to fully assess the case/make a causality assessment.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Developed approx 2 inch swollen area at injection site. Was sore & warm to touch. Resolved without further problems.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Injection site erythema, Injection site warmth, Pain, Pyrexia
Clinical narrative: 24 hours after vaccine, began feeling bad. Fever 102. (R) deltoid red, warm to touch, body aches. Taking ADVIL/TYLENOL for fever and body aches.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None, no fever, flu vaccine given to 2 month old male Lot # UT3641CA
Age: 10.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Abdominal pain, Erythema, Skin warm
Clinical narrative: 11/19/2010 GMom called stated that child got var & flu shots on 11/17. States child's arm was warm had reddened area palm size. States did not run a fever. States started complaining about 5 pm - c/o mild abdominal cramping, no diarrhea, no vomiting. Thurs (11/18) app good.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Gave a 3rd dose of flu vaccine.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Kawasaki's disease
Clinical narrative: Kawasaki's Disease < 24 hours after receiving FLUMIST.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arm below deltoid was red, hot and swollen. Some bruising was evident. Advised that she see her PCP. Dr decided it was an allergic reaction. Tx: BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site induration
Clinical narrative: 8 x 8 cm indurated area to left upper arm after FLUARIX and HAVRIX given 2 days ago.
Age: 15.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Computerised tomogram normal, Migraine, Nuclear magnetic resonance imaging brain, Paraesthesia, Photophobia
Clinical narrative: Patient reported migraine-like headache, photophobia, difficulty with speech and tingling of fingers in both hands which began 4d post vaccination.  Denied fever.  No previous migraine hx.
Age: 15.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Scan brain, Speech disorder
Clinical narrative: Patient reported migraine-like headache, photophobia, difficulty with speech and tingling of fingers in both hands which began 4d post vaccination.  Denied fever.  No previous migraine hx.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Pain
Clinical narrative: 2 days after seasonal flu shot (thimerosol free because I was 8 months pregnant) Chills, Nausea, achiness all over body, Achiness and nausea lasted 2 days.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Pyrexia, Rash, Swelling face
Clinical narrative: Pt noticed fevers and generally feeling unwell.  Then developed swelling in his face around the bridge of his nose.  Presented to the ER 11/20/2010.  Re-presented to the ER 11/26/2010 c/o rash.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Grand mal convulsion
Clinical narrative: Information has been received from a nurse practitioner and a registered nurse that a female who in 2007 was vaccinated with the first dose of GARDASIL (lot number not provided), in 2008 was vaccinated with the second dose of GARDASIL (lot number not provided), in 2009 was vaccinated with the third dose of GARDASIL (lot number not provided). It was reported that the patient had received the GARDASIL vaccinations at another physician's office. On 16-AUG-2010 the patient experienced the first grand mal seizure. The registered nurse stated that the patient has had a "bad year". The patient was a junior in high school and was "pretty much homebound at this time", per the patient's mother. The patient has seen a neurologist and a cardiologist (name of physicians were unknown to the reporter). At time of the report, the patient's outcome was unknown. Grand mal seizure was considered to be disabling by the reporter. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Dysphemia, Rash, Speech disorder
Clinical narrative: Information has been received from a consumer concerning her 32 month old, also reported as 24 months, daughter with no pertinent medical history, drug reactions or allergies reported, who on 25-OCT-2009 was vaccinated with a 0.5 mL first dose of RECOMBIVAX HB "in the leg, not SQ like the live vaccines but a regular injection" (lot # unknown). No concomitant medication reported. The consumer reported that "14 days after vaccination", on 08-DEC-2009, the patient experienced a rash on the hands. An unspecified dermatologist who said that the rash could have been eczema or contact dermatitis. The consumer stated that around that time, the patient was also stuck in a couple of words and her mother was not sure if the patient was going through a stage with her talking. The consumer reported that the patient had been playing in the leaves so the rash experienced possibly could have been from the leaves. The consumer reported that there was no fever or hives. No lab diagnostic studies performed. The patient sought medical attention in the dermatologist's office. It was reported that "1-2 weeks after rash occurred", on approximately 22-DEC-2009, the patient recovered from the rash on the hands which could have been eczema or contact dermatitis. At the time of the report, the status of the stuck on word was unknown. Follow up information has been received from a consumer concerning her 32 month old daughter with reactions to ATTENUVAX and MERUVAX. Consumer stated that "when her daughter was given RECOMBIVAX HB (lot # unknown), she had trouble getting her words out and was stuttering". Consumer also stated that her daughter was not going to finish the series for RECOMBIVAX HB. The patient was also vaccinated with a 0.5 ml dose of VARIVAX (Merck) (WAES#1001USA01886) and was diagnosed with pneumonia after vaccination. Upon internal review she was stuck in a couple of words/had trouble getting her words out was considered to be other important medical event. No further information is available. This is a consolidation of two reports concerning the same patient. It has been determined that WAES # 1011USA00486 is a duplicate of WAES # 1001USA00713. Therefore, WAES # 1011USA00486 is being deleted from our files and the reports consolidated into WAES # 1001USA00713.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Computerised tomogram head, Computerised tomogram normal, Convulsion, Electroencephalogram normal, Full blood count normal
Clinical narrative: This female subject was enrolled in the prophylactic study. On 18 November 2010, she received the 1st dose of Sanofi Pasteur's ACTHIB (IM R thigh), PEDIARIX (IM L thigh), Wyeth's PREVENAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 18 November 2010, on the same day after the 1st dose of ACTHIB, on the same day after the 1st dose of PEDIARIX, on the same day after the 1st dose of ROTARIX, on the same day after the 1st dose of PREVENAR 13, this one-month-old subject developed possible seizure. The subject was hospitalised. The subject was treated with acyclovir, ampicillin trihydrate, cefotaxime and paracetamol. The event resolved on 20 November 2010. The investigator considered that there was a reasonable possibility that the possible seizure may have been caused by ACTHIB, PEDIARIX, ROTARIX and PREVENAR 13. Subject was randomized to the study on 18NOV2010. Primary physician notified the clinic that subject experienced a seizure last evening and was hospitalized. Update 22Nov2010. Medical records obtained. Had spinal tap, CBC, head CT scan, EEG, all within normal limits. Neurology consult impression felt that this was a "blue episode" related to a passage of stool. Parents feel that this episode was a seizure or event of significance. Principal investigator confirms that this should be regarded as a possible seizure and possibly related to study vaccine.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Lumbar puncture normal
Clinical narrative: This female subject was enrolled in the prophylactic study. On 18 November 2010, she received the 1st dose of Sanofi Pasteur's ACTHIB (IM R thigh), PEDIARIX (IM L thigh), Wyeth's PREVENAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 18 November 2010, on the same day after the 1st dose of ACTHIB, on the same day after the 1st dose of PEDIARIX, on the same day after the 1st dose of ROTARIX, on the same day after the 1st dose of PREVENAR 13, this one-month-old subject developed possible seizure. The subject was hospitalised. The subject was treated with acyclovir, ampicillin trihydrate, cefotaxime and paracetamol. The event resolved on 20 November 2010. The investigator considered that there was a reasonable possibility that the possible seizure may have been caused by ACTHIB, PEDIARIX, ROTARIX and PREVENAR 13. Subject was randomized to the study on 18NOV2010. Primary physician notified the clinic that subject experienced a seizure last evening and was hospitalized. Update 22Nov2010. Medical records obtained. Had spinal tap, CBC, head CT scan, EEG, all within normal limits. Neurology consult impression felt that this was a "blue episode" related to a passage of stool. Parents feel that this episode was a seizure or event of significance. Principal investigator confirms that this should be regarded as a possible seizure and possibly related to study vaccine.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Erythema, Eye irritation, Throat irritation, Urticaria
Clinical narrative: dry cough, throat burn, eyes burning, face red, few hives on back
Age: 3.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Asthenia, Gait disturbance, Injection site pain, Paralysis, X-ray
Clinical narrative: Grandparents state child complained of right leg hurting after getting vaccination and going home.  State within a few days child was stumbling and is just got worse by getting weaker and weaker.  The paralysis progressed up to the right arm and today child states her right eye hurts.  Child is unable to move either extremity on right side.  Grandfather states they took child to facility and were told it was a virus and there was nothing they could do.  Grandparents took child to another facility and they did take an x-ray and are to be seen today again at clinic at 1330.  Child is alert and Grandfather states she has been eating well.  There is no redness or swelling to left leg where vaccination was given.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pruritus
Clinical narrative: Itching, started arms & legs, head during the night. The injection site was just a little sore, no redness or swelling.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain at injection site Described as "sore" Symptoms said to have persisted since initial vaccination date (10/14/10)
Age: 40.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Chills, Malaise, Pain, Pyrexia, Rash
Clinical narrative: Pt. c/o achiness, chills, fever of 101.2 and malaise - day 2 had mild rash on forearms. By day 3 all symptoms gone, only treatment was Advil for fever and achiness.
Age: 4.0
Sex: F
Vaccine: DTAP, DTP, IPV, VARCEL
Symptoms: Erythema, Inflammation, Pruritus, Pyrexia, Urticaria
Clinical narrative: Woke up, body was covered 90% with hives, red and inflammed.  Fever and itching. She had Benadryl, Tylenol and oatmeal baths...Sunday 11/29/2010 hives covering only a small portion of her legs to feet.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anxiety, Back pain, Blood pressure increased, Flushing, Musculoskeletal pain
Clinical narrative: Abrupt onset severe bilateral back and buttocks pain, facial flushing, anxiety, elevated blood pressure with no hypertension history.
Age: 55.0
Sex: M
Vaccine: MNQ
Symptoms: Bacterial infection, Lymph node pain, Lymphadenopathy, Oedema mouth, Oral pain
Clinical narrative: Left lymph node swollen and tender 1 hour after vaccine.  Tenderness inside mouth on L side. Swelled to size of golf ball when eating on Thursday and Friday.  Saw a PCP who diagnosed bacterial infection in gland and prescribed antibiotics.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Fainted after receiving Menactra at mass vaccination clinic. EMS attended clinic and evaluated her care.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Urticaria
Clinical narrative: PT NOTICED FEELING HOT APPROX 1/2 HOUR AFTER VACCINATION- PT THEN NOTICED HIVES ON LEFT ARM AND TRUNK AREA.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Pruritus, Skin warm, Swelling
Clinical narrative: Red and itchy, warm and swollen Topical Steroid
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Blood glucose normal, Dizziness, Presyncope
Clinical narrative: Near Syncope, felt dizzy and lightheaded after Menactra given at mass vaccination clinic. States he passes out with needle procedures ie vaccines and blood draws.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: COMPLAINTS OF PRURITIS AROUND SHOULDERS AND CHEST. NO SIGN OF RASH OR HIVES.
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: Blood glucose normal, Loss of consciousness, Syncope
Clinical narrative: Syncopal episode approximately 1 minute post vaccination.  Loss of consciousness 15 seconds.  No injury.
Age: 42.0
Sex: F
Vaccine: FLUX, FLUX(H1N1), PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Left thigh swelling with pain (9/10).
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Syncope, out a few seconds, following vaccination.  No injury, assisted fall.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Pain, Pain in extremity
Clinical narrative: Sore arm, which I attributed to the usual pain from a vaccine. I have the flu shot every year, so I wasn't concerned. However, pain continued and even increased as time went on. I can't lift my arm without severe pain, and the entire shoulder region is affected. My doctor believes that the shot was incorrectly put into my bursa cavity instead of the muscle. I did think that she administered the shot higher on my arm than usual. I've received physical therapy to try and help the pain, which has greatly affected my quality of life. My 90-year old grandmother also received her shot at the same time, and, fortunately, she is OK.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR
Symptoms: Rash papular
Clinical narrative: Red papules in clusters
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram, Guillain-Barre syndrome, Laboratory test, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Ascending paralysis and paresthsias of the upper and lower extremeties
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging thoracic, Paraesthesia
Clinical narrative: Ascending paralysis and paresthsias of the upper and lower extremeties
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Blood heavy metal normal, CSF protein increased, Lumbar puncture abnormal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Acute sensory neuropathy.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Peripheral sensory neuropathy, Treponema test negative
Clinical narrative: Acute sensory neuropathy.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal pain, Barium double contrast, Endoscopy, Intussusception, Ultrasound scan abnormal
Clinical narrative: Intussusception.  Abdominal pain started afternoon of 11-29.  Seen at ER, diagnosed by ultrasound, tried to reduce with air enema, but ultimately needed endoscopic reduction.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Urinary system X-ray
Clinical narrative: Intussusception.  Abdominal pain started afternoon of 11-29.  Seen at ER, diagnosed by ultrasound, tried to reduce with air enema, but ultimately needed endoscopic reduction.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: Any food that I put into my mouth tasted unpleasantly bitter.  I first noticed this at dinner a few hours after the injection.  The effect increased throughout the following day, and then tapered off the day after that. The total effect lasted about 36 - 48 hours.  Everything returned to normal.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Guillain-Barre syndrome, Immunoglobulin therapy, Influenza like illness
Clinical narrative: Flu like symptoms (2 days), joint pain & weakness (3 days) followed by diagnosis of Guillain Barre in emergency room & ICU (4 weeks)
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Intensive care, Laboratory test, Lumbar puncture, Mechanical ventilation, Plasmapheresis
Clinical narrative: Flu like symptoms (2 days), joint pain & weakness (3 days) followed by diagnosis of Guillain Barre in emergency room & ICU (4 weeks)
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Anaemia, Blood iron decreased, Chest pain, Computerised tomogram, Dyspnoea
Clinical narrative: Exhaustion, fatigue, chest pain, difficulty breathing over 2 days ER visit 3rd day with admit to hospital
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Haemoglobin decreased, Occult blood, Urine analysis, X-ray
Clinical narrative: Exhaustion, fatigue, chest pain, difficulty breathing over 2 days ER visit 3rd day with admit to hospital
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Mobility decreased, Pain, Sleep disorder
Clinical narrative: Shortly after receiving injection, my arm was very achey.  Took 600mg ibuprofen that evening, woke up the next morning with same pain.  Weeks later, it still hurts.  Can't raise my arm, twist to put on jacket, sleep on arm, lift any weight.  Disrupts my sleep several times a night.  Experience lots of pain while driving.  Can't hold my kids with that arm. I know, wa wa wa, I am a baby, but it really hurts!
Age: 30.0
Sex: F
Vaccine: DT, MMR, TD
Symptoms: Blood test normal, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging normal, Tremor
Clinical narrative: Resting tremor in the vaccinated left arm. Progressed to the left leg in May and the right arm/trunk/neck in November. Diagnosed with resting tremor in November.
Age: 0.65
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Irritability, Pyrexia, Rash generalised
Clinical narrative: FEVER AFTER 3 DAYS, RASH ON BODY AND FUSSY
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Pt was immunized with Influenza on 11-23 and on the next day 11-24 she was taken to the ED. There site was described as 3cc diameter area of redness with tenderness. MD states cellulitis. Tx with KEFLEX.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site induration, Injection site pain
Clinical narrative: Immediately after vaccine was administered, complained of pain at the site. The area was hard and became ecchymotic immediately.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: First pain at sight - but instead of going away after a few days - 3 wks. later still sore if touched. Also I can't lift arm straight above head without a shooting pain or some side movements trigger a pain as well. Slightly better this last week.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: HIV test, Hepatitis B virus test, Hepatitis C virus test, Injury associated with device
Clinical narrative: After giving patient a flu shot; pharmacist pushed plunger down until clicking however it did not retract and needle scrapped left thumb. Pharmacist did not notice injury until removing gloves. Reported injury after noticing the stick.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Hyperhidrosis, Injected limb mobility decreased, Injection site pain
Clinical narrative: Cough, chills, cannot lift arm without pain, nauseous, severe headache. Could not get out of bed last night. Went to facility this morning. Sore arm at time of shot. Felt ok until 4-5 hours after shot. Probably feverish, sweating all night but no thermometer.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Tenderness
Clinical narrative: Cough, chills, cannot lift arm without pain, nauseous, severe headache. Could not get out of bed last night. Went to facility this morning. Sore arm at time of shot. Felt ok until 4-5 hours after shot. Probably feverish, sweating all night but no thermometer.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt given IM influenza vaccine. On 11-2-10. Pt was previously vaccinated with nasal vaccine 9-27-10. Therefore pt received 2 influenza vaccines and for this season and 1 influenza vaccine 5-12-10.
Age: 52.0
Sex: M
Vaccine: FLU3, TDAP, TYP
Symptoms: Arthralgia, Rash
Clinical narrative: Patient complaining of achiness in joints the day after receiving vaccinations. Pt. also complained of rash on left arm and trunk. Denied shortness of breath, fever, or any respiratory symptoms.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Chills, Ear pain, Feeling abnormal, Influenza like illness
Clinical narrative: Patient called office to report reaction to Flu shot. Has been to doctor 3x and been on 3 rounds of antibiotics. Had lump in arm at injection site and felt bad that night and the next day. Lump went away and felt better but 2 wks later lumps returned and had major flu like symptoms. Achy all over body, arm hurt to move, pains all over body. Went to doctor put on antibiotics and felt better. Few days later started feeling bad again, chills, achy, lumps in neck at Adams apple, lymph nodes inflammed. Antibiotics again. Felt better but is still not up to par - Still has aches all over body lump in neck, on antibiotics till just before Thanksgiving. Ear hurts. Eyes water.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Neck mass, Pain, Thyroid function test normal
Clinical narrative: Patient called office to report reaction to Flu shot. Has been to doctor 3x and been on 3 rounds of antibiotics. Had lump in arm at injection site and felt bad that night and the next day. Lump went away and felt better but 2 wks later lumps returned and had major flu like symptoms. Achy all over body, arm hurt to move, pains all over body. Went to doctor put on antibiotics and felt better. Few days later started feeling bad again, chills, achy, lumps in neck at Adams apple, lymph nodes inflammed. Antibiotics again. Felt better but is still not up to par - Still has aches all over body lump in neck, on antibiotics till just before Thanksgiving. Ear hurts. Eyes water.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Cellulitis, Erythema, Injected limb mobility decreased, Injection site pain
Clinical narrative: 5 d after IM FLUZONE, pt. developed pain and tightness LUA progressing to LFA and LH. Pain 6/10. Unable to put coat on or raise LA above shoulder. 5d later LUA improved but unable to internally rotate without pain LAFA. Unable to type, Sore red area LAFA distal LAC NTTP. Went to Urgent Care - dx'd Cellulitis. Tx BACTRIM NOS. No lab tests done. 11/29/10 Saw Orthopedist who stated no bone infection/X-ray. Gave pt. Rx for PT, MRI. Pt. states arm improving.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Pain in extremity, Skin tightness, X-ray normal
Clinical narrative: 5 d after IM FLUZONE, pt. developed pain and tightness LUA progressing to LFA and LH. Pain 6/10. Unable to put coat on or raise LA above shoulder. 5d later LUA improved but unable to internally rotate without pain LAFA. Unable to type, Sore red area LAFA distal LAC NTTP. Went to Urgent Care - dx'd Cellulitis. Tx BACTRIM NOS. No lab tests done. 11/29/10 Saw Orthopedist who stated no bone infection/X-ray. Gave pt. Rx for PT, MRI. Pt. states arm improving.