chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Myalgia
Clinical narrative: Had Fluarix vaccine 11/14/05 in AM. On 11/15/05 while driving home noticed vaccinated arm felt tired. Better in AM but symptoms return as day progressed. Continued to have these symptoms.
Age: 14.0
Sex: F
Vaccine: FLU3, HEPA, MNQ
Symptoms: Tongue oedema, Urticaria
Clinical narrative: At 01:30, 16 1/2 hours after immunization, awoke with urticaria, generalized, and slight tongue swelling. Given Benadryl. Urticaria gave in AM. No respiratory symptoms.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Got progressively worse. Felt sleep, tired, fatigued, nausea, dizzy. By noon next day ached head to toe, fever close to 100 degrees; took aspirin.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Somnolence
Clinical narrative: Got progressively worse. Felt sleep, tired, fatigued, nausea, dizzy. By noon next day ached head to toe, fever close to 100 degrees; took aspirin.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Erythema, Throat tightness
Clinical narrative: Pt given flu vaccine in right deltoid. Pt arm turned red, pt c/o throat tightness and chest tightness. Benadryl 50 mg im gulln. Motrin 600mg PO gulln.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Oedema peripheral
Clinical narrative: Arm - shoulder to elbow swollen by 24 hrs after shot 2/3 of length. 1/4 width red, warm. RX with claritin 5mg, motrin, and cool compresses.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Abnormal behaviour, Discomfort
Clinical narrative: Discomfort at site of shots-Aggressive behavior which occurred 24-36 hours after admin and lasted 10-14 days
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Erythema, Swelling
Clinical narrative: Left arm  developed with swelling and redness. Tx 2d
Age: 3.0
Sex: F
Vaccine: HBHEPB, PNC, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Patient onset with rash on trunk anterior/posterior with itching. Taken to hospital (ER) on 11/11/05 and diagnosed with chickenpox.
Age: 36.0
Sex: F
Vaccine: DT
Symptoms: Hypokinesia, Injection site mass, Paraesthesia, Tenderness
Clinical narrative: 11/10/05 felt tingling down left arm, left arm felt dead. Unable to lift arm. Local reaction lump at injection site with tenderness. Was using Advil, is being sent for tests. Symptoms improved slightly.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Dysarthria, Dyspnoea, Fatigue, Hallucination
Clinical narrative: First Hep A vaccine on 10/05/2005. On 11/07/05 after vaccine felt light headed on 11/08 woke up with hallucinations, could see air, numbness of foot and leg, blurred vision like out of focus, tired, fatigued, slurred speech. By 5 pm friend arrived with Nyquil and noticed glassy eyes, was still having hallucination was seeing smoke like people figures. Taken to the ER, there had problems breathing, still had hallucinations. Given steroids and IV released by night and doctor mentioned that it was a severe allergic reaction. At home, at 11pm, began to hallucinate again, was seeing walls that were not there and curtains took shape of people. Breathing problems reoccurred. On 11/9 at 2-3am hallucinations stopped. Have been having night sweats, hearing went rot, and vision is blurry.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Hypersensitivity, Hypoacusis, Hypoaesthesia, Night sweats, Staring
Clinical narrative: First Hep A vaccine on 10/05/2005. On 11/07/05 after vaccine felt light headed on 11/08 woke up with hallucinations, could see air, numbness of foot and leg, blurred vision like out of focus, tired, fatigued, slurred speech. By 5 pm friend arrived with Nyquil and noticed glassy eyes, was still having hallucination was seeing smoke like people figures. Taken to the ER, there had problems breathing, still had hallucinations. Given steroids and IV released by night and doctor mentioned that it was a severe allergic reaction. At home, at 11pm, began to hallucinate again, was seeing walls that were not there and curtains took shape of people. Breathing problems reoccurred. On 11/9 at 2-3am hallucinations stopped. Have been having night sweats, hearing went rot, and vision is blurry.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Vision blurred
Clinical narrative: First Hep A vaccine on 10/05/2005. On 11/07/05 after vaccine felt light headed on 11/08 woke up with hallucinations, could see air, numbness of foot and leg, blurred vision like out of focus, tired, fatigued, slurred speech. By 5 pm friend arrived with Nyquil and noticed glassy eyes, was still having hallucination was seeing smoke like people figures. Taken to the ER, there had problems breathing, still had hallucinations. Given steroids and IV released by night and doctor mentioned that it was a severe allergic reaction. At home, at 11pm, began to hallucinate again, was seeing walls that were not there and curtains took shape of people. Breathing problems reoccurred. On 11/9 at 2-3am hallucinations stopped. Have been having night sweats, hearing went rot, and vision is blurry.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Joint range of motion decreased, Muscle fatigue, Oedema peripheral, Pain in extremity
Clinical narrative: 10/25/2005 Tuesday as flu vaccine was being administered, I complained of severe burning pain in my arm, By that evening my arm was painful and starting to swell. 10/26 in am my arm was more edematous and I felt more burning pain. 10/27 around 11:00am I went to ER. There was now edema from my elbow to my shoulder. Pain persisted. The ER doctor thought it was a local reaction and it would pass. 10/28 all symptoms were worse. 10/29 edema was not into the soft tissue in my back, under my arms and into my left breast. The pain was severe. It felt like nerve pain (burning)and as though my arm was constricting. The ER doctor prescribed Prednisone 40 mg for 4 days. He stated he had no idea what was happening. 10/30 by Sunday evening the generalized edema and pain was worse and there was now redness and heat at the injection site. I felt clammy and nauseated. I went to the ER. they started IV Vancomycin and admitted me. I was there for 10 days. 10/31 - Nov 3 labs and CT scan were negative. I believe staph was cultured from my nose. A second Iv Antibiotic was added. Dr discontinued the antibiotics on Nov 3, as I was not responding. During this time the edema worsened and the severe pain continued. Also the lymph nodes under my arms and in my groin were swollen and painful. He then thought it might be an allergic response. Solumedrol was started. 11/04 - 11/07 there was some improvement in the area of the lymph nodes (less swelling and pain) and the edema in my arm was slightly reduced but the pain remained. On Monday 11/07 Dr called in an allergist/immunologist. 11/08 an MRI was done it showed layers of fluid in the soft tissues. I also saw the allergist. her assessment was that this was not an allergic reaction by a atypical reaction to an irritant in the vaccine. 11/09 Put on PO Prednisone. 11/10 Discharged on Prednisone in declining dose for seven days. Follow up appointment with allergist. (not seen as yet). 11/15 Tuesday there has been some improvement in the generalized soft tissue edema. The edema in my arm is slightly improved. The burning pain also seems to be slowly resolving.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pyrexia, Skin warm
Clinical narrative: 10/25/2005 Tuesday as flu vaccine was being administered, I complained of severe burning pain in my arm, By that evening my arm was painful and starting to swell. 10/26 in am my arm was more edematous and I felt more burning pain. 10/27 around 11:00am I went to ER. There was now edema from my elbow to my shoulder. Pain persisted. The ER doctor thought it was a local reaction and it would pass. 10/28 all symptoms were worse. 10/29 edema was not into the soft tissue in my back, under my arms and into my left breast. The pain was severe. It felt like nerve pain (burning)and as though my arm was constricting. The ER doctor prescribed Prednisone 40 mg for 4 days. He stated he had no idea what was happening. 10/30 by Sunday evening the generalized edema and pain was worse and there was now redness and heat at the injection site. I felt clammy and nauseated. I went to the ER. they started IV Vancomycin and admitted me. I was there for 10 days. 10/31 - Nov 3 labs and CT scan were negative. I believe staph was cultured from my nose. A second Iv Antibiotic was added. Dr discontinued the antibiotics on Nov 3, as I was not responding. During this time the edema worsened and the severe pain continued. Also the lymph nodes under my arms and in my groin were swollen and painful. He then thought it might be an allergic response. Solumedrol was started. 11/04 - 11/07 there was some improvement in the area of the lymph nodes (less swelling and pain) and the edema in my arm was slightly reduced but the pain remained. On Monday 11/07 Dr called in an allergist/immunologist. 11/08 an MRI was done it showed layers of fluid in the soft tissues. I also saw the allergist. her assessment was that this was not an allergic reaction by a atypical reaction to an irritant in the vaccine. 11/09 Put on PO Prednisone. 11/10 Discharged on Prednisone in declining dose for seven days. Follow up appointment with allergist. (not seen as yet). 11/15 Tuesday there has been some improvement in the generalized soft tissue edema. The edema in my arm is slightly improved. The burning pain also seems to be slowly resolving.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cold sweat, Hypersensitivity, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: 10/25/2005 Tuesday as flu vaccine was being administered, I complained of severe burning pain in my arm, By that evening my arm was painful and starting to swell. 10/26 in am my arm was more edematous and I felt more burning pain. 10/27 around 11:00am I went to ER. There was now edema from my elbow to my shoulder. Pain persisted. The ER doctor thought it was a local reaction and it would pass. 10/28 all symptoms were worse. 10/29 edema was not into the soft tissue in my back, under my arms and into my left breast. The pain was severe. It felt like nerve pain (burning)and as though my arm was constricting. The ER doctor prescribed Prednisone 40 mg for 4 days. He stated he had no idea what was happening. 10/30 by Sunday evening the generalized edema and pain was worse and there was now redness and heat at the injection site. I felt clammy and nauseated. I went to the ER. they started IV Vancomycin and admitted me. I was there for 10 days. 10/31 - Nov 3 labs and CT scan were negative. I believe staph was cultured from my nose. A second Iv Antibiotic was added. Dr discontinued the antibiotics on Nov 3, as I was not responding. During this time the edema worsened and the severe pain continued. Also the lymph nodes under my arms and in my groin were swollen and painful. He then thought it might be an allergic response. Solumedrol was started. 11/04 - 11/07 there was some improvement in the area of the lymph nodes (less swelling and pain) and the edema in my arm was slightly reduced but the pain remained. On Monday 11/07 Dr called in an allergist/immunologist. 11/08 an MRI was done it showed layers of fluid in the soft tissues. I also saw the allergist. her assessment was that this was not an allergic reaction by a atypical reaction to an irritant in the vaccine. 11/09 Put on PO Prednisone. 11/10 Discharged on Prednisone in declining dose for seven days. Follow up appointment with allergist. (not seen as yet). 11/15 Tuesday there has been some improvement in the generalized soft tissue edema. The edema in my arm is slightly improved. The burning pain also seems to be slowly resolving.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling, Injection site warmth, Lymphadenopathy, Nausea, Skin burning sensation
Clinical narrative: 10/25/2005 Tuesday as flu vaccine was being administered, I complained of severe burning pain in my arm, By that evening my arm was painful and starting to swell. 10/26 in am my arm was more edematous and I felt more burning pain. 10/27 around 11:00am I went to ER. There was now edema from my elbow to my shoulder. Pain persisted. The ER doctor thought it was a local reaction and it would pass. 10/28 all symptoms were worse. 10/29 edema was not into the soft tissue in my back, under my arms and into my left breast. The pain was severe. It felt like nerve pain (burning)and as though my arm was constricting. The ER doctor prescribed Prednisone 40 mg for 4 days. He stated he had no idea what was happening. 10/30 by Sunday evening the generalized edema and pain was worse and there was now redness and heat at the injection site. I felt clammy and nauseated. I went to the ER. they started IV Vancomycin and admitted me. I was there for 10 days. 10/31 - Nov 3 labs and CT scan were negative. I believe staph was cultured from my nose. A second Iv Antibiotic was added. Dr discontinued the antibiotics on Nov 3, as I was not responding. During this time the edema worsened and the severe pain continued. Also the lymph nodes under my arms and in my groin were swollen and painful. He then thought it might be an allergic response. Solumedrol was started. 11/04 - 11/07 there was some improvement in the area of the lymph nodes (less swelling and pain) and the edema in my arm was slightly reduced but the pain remained. On Monday 11/07 Dr called in an allergist/immunologist. 11/08 an MRI was done it showed layers of fluid in the soft tissues. I also saw the allergist. her assessment was that this was not an allergic reaction by a atypical reaction to an irritant in the vaccine. 11/09 Put on PO Prednisone. 11/10 Discharged on Prednisone in declining dose for seven days. Follow up appointment with allergist. (not seen as yet). 11/15 Tuesday there has been some improvement in the generalized soft tissue edema. The edema in my arm is slightly improved. The burning pain also seems to be slowly resolving.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Swelling
Clinical narrative: 10/25/2005 Tuesday as flu vaccine was being administered, I complained of severe burning pain in my arm, By that evening my arm was painful and starting to swell. 10/26 in am my arm was more edematous and I felt more burning pain. 10/27 around 11:00am I went to ER. There was now edema from my elbow to my shoulder. Pain persisted. The ER doctor thought it was a local reaction and it would pass. 10/28 all symptoms were worse. 10/29 edema was not into the soft tissue in my back, under my arms and into my left breast. The pain was severe. It felt like nerve pain (burning)and as though my arm was constricting. The ER doctor prescribed Prednisone 40 mg for 4 days. He stated he had no idea what was happening. 10/30 by Sunday evening the generalized edema and pain was worse and there was now redness and heat at the injection site. I felt clammy and nauseated. I went to the ER. they started IV Vancomycin and admitted me. I was there for 10 days. 10/31 - Nov 3 labs and CT scan were negative. I believe staph was cultured from my nose. A second Iv Antibiotic was added. Dr discontinued the antibiotics on Nov 3, as I was not responding. During this time the edema worsened and the severe pain continued. Also the lymph nodes under my arms and in my groin were swollen and painful. He then thought it might be an allergic response. Solumedrol was started. 11/04 - 11/07 there was some improvement in the area of the lymph nodes (less swelling and pain) and the edema in my arm was slightly reduced but the pain remained. On Monday 11/07 Dr called in an allergist/immunologist. 11/08 an MRI was done it showed layers of fluid in the soft tissues. I also saw the allergist. her assessment was that this was not an allergic reaction by a atypical reaction to an irritant in the vaccine. 11/09 Put on PO Prednisone. 11/10 Discharged on Prednisone in declining dose for seven days. Follow up appointment with allergist. (not seen as yet). 11/15 Tuesday there has been some improvement in the generalized soft tissue edema. The edema in my arm is slightly improved. The burning pain also seems to be slowly resolving.
Age: 1.01
Sex: M
Vaccine: HBHEPB, PNC, VARCEL
Symptoms: Autism
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 2 year old male patient who was diagnosed with pervasive developmental disorder. At 12 months of age, the patient received the fourth dose on Oct 9 2003. The patient also received the third dose of Comvax (haemophilus B conjugate vaccine hepatitis B vaccine) and the second dose of Varivax (varicella virus vaccine, live) on Oct 9 2003. Patient reported to be healthy other than PDD diagnosis. Indication for Prevnar was immunisation. Product was administered on Oct 9 2003. Dose regimen was 1 dose intramuscular. Additional suspect medication included Comvax, MMR, Polio vaccine, and Tripedia. Concomitant medication were not reported. The mother of the patient reported that her son, at age 2, was diagnosed with pervasive developmental disorder (autism spectrum disorder) in Oct 2004. No additional information was available at the time of this report.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope, Tremor, White blood cell count increased
Clinical narrative: (OMIC). Initial report received from a patients parent on Nov 7 2005. A 30 year old female patient with a medical history of asthma and an allergy to dog and cat dander received a left deltoid injection of Fluzone SV 2005-2006, lot number U1764AA, on Nov 4 2005. The route of administration was not reported. The patient had received no previous doses. Five to ten minutes following vaccination, the patient fainted. The patient was also shaking. She was examined in an emergency room and discharged. Per the reporter, an electrocardiogram was normal, and the patient had an elevated white blood cell count. There were no illness at the time of vaccination, although, the patient had an unspecified illness a week prior to vaccination. Other medications were birth control pills. At the time of this report, the recovery status was unknown.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphemia, Hyperaesthesia, Paraesthesia, Paralysis, Peripheral coldness
Clinical narrative: Initial report received from a health care provider on Nov 8 2005. A 49 year old female patient with a possible history of asthma or COPD received an intramuscular deltoid injection of Fluzone no preservative 2005 2006. lot number U1802BA, on Oct 25 2005. Eight days later, she developed sensitivity to touch and an alternate sensation of burning and cold to both lower extremities. On Nov 5 2005, these symptoms became worse with the additional onset of stuttering. On Nov 7 2005, the patient experienced decreased feeling, an inability to move both lower extremities and was hospitalized. Per the reporter, results are pending for an MRI of the brain without contrast and a lumbar puncture culture, VDRL, bacteria, virus, and fungal. At the time of this report, the diagnosis was unconfirmed. The patient was treated with prednisone starting on Nov 2 2005 and discontinued at the time of hospitalization. The patient denied illness at the time of vaccination, and other medications were not reported. Number of previous doses was reported as past years. At the time of this report, recovery status was not reported.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Sensory disturbance, Skin burning sensation
Clinical narrative: Initial report received from a health care provider on Nov 8 2005. A 49 year old female patient with a possible history of asthma or COPD received an intramuscular deltoid injection of Fluzone no preservative 2005 2006. lot number U1802BA, on Oct 25 2005. Eight days later, she developed sensitivity to touch and an alternate sensation of burning and cold to both lower extremities. On Nov 5 2005, these symptoms became worse with the additional onset of stuttering. On Nov 7 2005, the patient experienced decreased feeling, an inability to move both lower extremities and was hospitalized. Per the reporter, results are pending for an MRI of the brain without contrast and a lumbar puncture culture, VDRL, bacteria, virus, and fungal. At the time of this report, the diagnosis was unconfirmed. The patient was treated with prednisone starting on Nov 2 2005 and discontinued at the time of hospitalization. The patient denied illness at the time of vaccination, and other medications were not reported. Number of previous doses was reported as past years. At the time of this report, recovery status was not reported.
Age: 47.0
Sex: F
Vaccine: FLUN3
Symptoms: Chest discomfort, Dehydration, Fatigue, Headache, Nasal congestion
Clinical narrative: A 47 year old nurse, with prior history of asthma, reported that she began to experience chest tightness, wheezing, scratchy throat, tiredness, nasal congestion, headache, runny nose, body ache and dehydration, 3 days after she received FluMist on Oct 7 2005. She was seen by her primary physician and was given nebulization treatments for her wheezing. She was also prescribed an unspecified antibiotic which had to be changed to Avelox (moxifloxacin) and oral decongestants. She also received intravenous hydration as she felt dehydrated. As of Oct 28 2005, the patient continues to have nasal congestion, headache, runny nose, tiredness and body aches. All other symptoms have resolved. The patient also stated that other members in her family received FluMist but did not experience any adverse event. The reporter assessed the events as possibly related to FluMist.
Age: 47.0
Sex: F
Vaccine: FLUN3
Symptoms: Pain, Pharyngolaryngeal pain, Rhinorrhoea, Wheezing
Clinical narrative: A 47 year old nurse, with prior history of asthma, reported that she began to experience chest tightness, wheezing, scratchy throat, tiredness, nasal congestion, headache, runny nose, body ache and dehydration, 3 days after she received FluMist on Oct 7 2005. She was seen by her primary physician and was given nebulization treatments for her wheezing. She was also prescribed an unspecified antibiotic which had to be changed to Avelox (moxifloxacin) and oral decongestants. She also received intravenous hydration as she felt dehydrated. As of Oct 28 2005, the patient continues to have nasal congestion, headache, runny nose, tiredness and body aches. All other symptoms have resolved. The patient also stated that other members in her family received FluMist but did not experience any adverse event. The reporter assessed the events as possibly related to FluMist.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Pneumonia, Pyrexia
Clinical narrative: A pharmacist reported that a 7 year old male experienced pneumonia, fever and cough one day after receiving FluMist on Oct 21 2005. On Oct 22 2005, the patient developed a fever of 100 degrees F. On Oct 23 2005, he was brought to an urgent care center where he was prescribed oral Ceftin (Cefuroxime). On Oct 24 2005, the high grade fever persisted (temperature unrecalled) and the patient started to cough. On Oct 27 2005, a chest x ray showed pneumonia on the right upper lobe. He was seen at the doctors office, where he was given one dose of Rocephin (Ceftriaxone) via intramuscular injection. He was then sent home with prescription of oral Augmentin (co amoxiclav). The patient has not yet recovered from the adverse events at the time of this report. The reporter assessed the events as possibly related to FluMist. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Oedema, Pain, Paraesthesia
Clinical narrative: 12 hours later very painful, 24 hours whole left arm swollen, numbness down left arm from armpit to palm. 2 large red welts with itching. Extremely painful 72 hours left hand tingly and cooler than right side. 1 welt still visible 6" under injection site.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral coldness, Pruritus, Urticaria
Clinical narrative: 12 hours later very painful, 24 hours whole left arm swollen, numbness down left arm from armpit to palm. 2 large red welts with itching. Extremely painful 72 hours left hand tingly and cooler than right side. 1 welt still visible 6" under injection site.
Age: 14.0
Sex: F
Vaccine: FLU3, MNQ, PPV
Symptoms: Erythema, Feeling hot, Headache, Injection site induration, Nausea
Clinical narrative: Left upper arm became red, warm to touch swollen and sore. pt had also developed nausea, vomiting, and headache. Red area 5 inches x 7 inches indurated.
Age: 14.0
Sex: F
Vaccine: FLU3, MNQ, PPV
Symptoms: Oedema, Pain, Vomiting
Clinical narrative: Left upper arm became red, warm to touch swollen and sore. pt had also developed nausea, vomiting, and headache. Red area 5 inches x 7 inches indurated.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Pain, Pruritus
Clinical narrative: Received flu vaccine 10:30am noticed itching 10 mins after then hot and aching after 30 minutes. Returned to health dept 11:15am referred to MD.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Dry skin, Injection site nodule, Injection site swelling, Pruritus
Clinical narrative: Pt stated he noted a bump at injection site after receiving a flu shot 2 weeks ago. Added he did not look at area but started scratching it through his shirt. Denies redness, swelling or pain. During assessment of site by medical director it was noted to be a dry, raised area the size of 1 x 0.9 cm. No signs of infection was noted and director advised pt to keep area clean and if it becomes reddened or swollen to return.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Hot flush, Hyperhidrosis, Nausea, Stomach discomfort
Clinical narrative: Upset stomach, nausea, felt hot, sweaty no fever.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Dry mouth, Heart rate irregular, Hypersensitivity
Clinical narrative: Lightheadedness about 1 1/2 hour after injection, BP increased, HR irregular, felt faint, dry mouth, overall achiness. PCP diagnosed allergic reaction.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Lightheadedness about 1 1/2 hour after injection, BP increased, HR irregular, felt faint, dry mouth, overall achiness. PCP diagnosed allergic reaction.
Age: 1.02
Sex: M
Vaccine: FLU3, HIBV, IPV, MMR, PNC
Symptoms: Hypersensitivity, Injection site reaction, Injection site urticaria
Clinical narrative: Urticaria at site of RVL immunization given Prevnar seen by MD at health dept Dx allergic reaction right upper thigh at site of immunization 4th dose of Prevnar given at that site.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, HEP, IPV
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site reaction
Clinical narrative: Foster mom reports 2" redness and 1" diameter lump in area of IPOL site. LA SQ. DTaP given in Left deltoid.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Severe piercing pain rippling from left side of pelvis to right side occurring 5 minutes after vaccination (Flu) to left deltoid muscle.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased
Clinical narrative: Within 5 minutes I had of the flu shot, a fast heart beat. It lasted 1 hour.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Injection site rash, Pityriasis rosea, Rash pruritic
Clinical narrative: Pruritic erythematous Trunk, thigh rash 2 weeks after Menactra. Coincided with out of doors lake exposure minimal response to steroids and antihistamines. No herald patch. Gradually resolved after about 3-7 weeks. Was also treated with Elimite. Doubt relation, but unclear etiology ratio. Additional notes attached from DR. Student with raised chiggeretic itching rash to thighs, buttocks and abdomen minimal excoriation. No gross cellulitis. No definite herald patch identified. Chest clear no respiratory distress. No definite mites or scabies identified. Chest and shoulders free of rash. Rash now of one month duration. Unresponsive to Loratadine and 1% Hydrocortisone. Student with Menactra injection development of rash approximately two weeks after injection rash developed also correlating with fishing out of doors exposure. I think it is more likely that this represents a rash secondary to exposure on the creek bank than a reaction to the vaccine. Though I don't see definite mites in the finger webs or on the feet, will treat with Elimite Cream as recommended. As the majority of the rash is in the areas covered by layers of clothing, I anticipate that being cool, clean and dry will result in reduction of symptoms. Pityriasis remains a possibility, but no definite herald patch identified.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Large reddened 60 mm area round.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fall, Movement disorder
Clinical narrative: < 24 hours after Flu immunization, had complete loss of function of legs, falling, extreme weakness. That slowly resolved over 24 - 36 hours.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot
Clinical narrative: Left upper arm red and warm to touch, non indurated. Approx 22 x 12 cm erythema. TX antibiotic, antihistamine.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pruritus, Rash
Clinical narrative: Feeling of being light headed, dizziness, itching then rash.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Malaise, Pharyngolaryngeal pain
Clinical narrative: Enlarged lymph node in supraclavicular area in same side as vaccine was given. No pain, no fever. Malaise, sore throat 11/10/2005 4:00 am.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Eye discharge, Eye pain, Eye swelling, Ocular hyperaemia, Pain
Clinical narrative: Developed fever, body aches, but the most unusual, unexpected reaction was intense red color in both eyes, discharge swollen eyes, with pain, symptoms lasted into the second day. cleared on 3rd day.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Developed fever, body aches, but the most unusual, unexpected reaction was intense red color in both eyes, discharge swollen eyes, with pain, symptoms lasted into the second day. cleared on 3rd day.
Age: 1.16
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Feeling hot, Injection site oedema, Pyrexia
Clinical narrative: Received DPaT in right upper thigh on 11/09/2005, had fever first night (Tactile), Resolved. Today has warm swollen local reaction 5 x 5 cm. NO fever, eating well. No systemic SXS, no red streaks.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Hypokinesia, Injection site oedema, Injection site reaction, Pain
Clinical narrative: Left upper extremity swollen swollen and painful on moving blotch the size of a silver dollar. Cool compress, Tylenol for pain. Discomfort 2-3 days at site of pneumococcal injection site.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash macular
Clinical narrative: Left upper extremity swollen swollen and painful on moving blotch the size of a silver dollar. Cool compress, Tylenol for pain. Discomfort 2-3 days at site of pneumococcal injection site.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Hyperaesthesia, Injection site reaction, Skin discolouration
Clinical narrative: Pt reports that by 11/11/2005 in the evening hours she had area patch that was warm to the touch about 7cm long a small orange size per pt. By Saturday 11/12/2005, pat reported redness had spread down her arm further, was very sensitive to the touch and had a darker center right around where shot was given. Pt is here on 11/14/2005 and arm is still red. Almost circumferential about 15-30cm in size. Given PRX of Keflex 500 mg QID x 7 days on 11/14/2005. The redness was around where pt was given Pneumovax vaccine.
Age: 0.11
Sex: F
Vaccine: HEP
Symptoms: Agitation, Crying
Clinical narrative: Excessive crying.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Pruritus, Rash, Rash macular
Clinical narrative: A blotch red ring developed around the upper arm. The rash had localized pain and itching. painful for 2 days. Treated with Tylenol, Motrin, and Benadryl tabs.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site induration, Pain, Pruritus
Clinical narrative: 2 1/2 x 3 inches, Knot on inner right thigh erythematous, warm to touch, painful, pruritic, no arthralgia/fever, 4 year immunizations given 1 day prior at another clinic. DTap, MMR right leg, IPV left leg.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema, Oedema
Clinical narrative: Vaccines given 11/08/2005 seen in office 11/10/2005 redness and edema, bilateral thigh. TX with Keflex PO.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Edema below deltoid to about 2 inches from elbow slight red, painful x 2 days. TX cool compresses, Benadryl PO PRN.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis left upper arm.
Age: 1.0
Sex: F
Vaccine: HIBV, IPV, VARCEL
Symptoms: Erythema, Injection site hypersensitivity, Injection site oedema, Injection site reaction, Oedema
Clinical narrative: Received vaccines 11/07/2005 mom states red and swollen at site of varicella vaccine starting 11/08/2005 am and 11/08/2005 pm, generalized rash and red, swollen arm.
Age: 1.0
Sex: F
Vaccine: HIBV, IPV, VARCEL
Symptoms: Rash
Clinical narrative: Received vaccines 11/07/2005 mom states red and swollen at site of varicella vaccine starting 11/08/2005 am and 11/08/2005 pm, generalized rash and red, swollen arm.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Feeling hot, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Evening of 11/08 area around injection site swelled, red, and hot, painful. Day of 11/09 further swelling, erythema, heat and discomfort entire upper arm. Advised in Pm to take Benadryl, apply ice for 15-20 mins Q3-4H, Tylenol for Discomfort. 11/10 am advised to continue the same, increase fluids 5pm symptoms decreased.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Oedema
Clinical narrative: Evening of 11/08 area around injection site swelled, red, and hot, painful. Day of 11/09 further swelling, erythema, heat and discomfort entire upper arm. Advised in Pm to take Benadryl, apply ice for 15-20 mins Q3-4H, Tylenol for Discomfort. 11/10 am advised to continue the same, increase fluids 5pm symptoms decreased.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Pruritus, Urticaria
Clinical narrative: Vaccines given approx noon 11/07/2005 by that evening left arm became red, hot to touch, itching. Treated with hydrocortisone cream with partial improvement but still itchy. Exam showed urticarial rash, no swelling. Treated with oral Benadryl. Hydrocortisone cream with good results.
Age: 0.21
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Hypersensitivity, Irritability, Oedema peripheral, Rash macular, Skin discolouration
Clinical narrative: Pt had immunizations in office 11/10/2005 am, mom called our office after hrs and spoke with DR. Mom stated she is in car with child and his legs have blue splotches and legs and feet swollen and he started fussing. Mom took pt to ER for eval per DR orders per mom PT DX possible vaccine reaction. Tylenol given ant legs massaged after 40 minutes pt did better.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema
Clinical narrative: Pt received DTap IM and IPV SQ on left deltoid. Area became erythematous and deltoid slightly firmer as compared to right deltoid.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema
Clinical narrative: Arm Swollen 13x 12cm redness, swelling streaking around inner part of upper arm. Give Keflex 200 mg, Benadryl and RTC 11/15.
Age: 12.0
Sex: M
Vaccine: TD, VARCEL
Symptoms: Feeling hot, Injection site oedema, Injection site reaction, Pruritus, Pyrexia
Clinical narrative: 1 day after varicella, arm got warm, itchy and swollen at injection site. Had temp 100.3 10/18/2005.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: 40-50 spots a few on face, axilla but mostly on trunk.
Age: 17.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Abdominal pain upper, Erythema, Feeling hot, Headache, Hypokinesia
Clinical narrative: High fever of (102.8 degrees) head hurt, arm was red, hot, swollen, and could not lift, hurt underarm along the arm pit and left lung area, vomiting pain in stomach, sic for 4 days could not even stand. Head, arm and lung area hurts so bad! Sick for 4 days in bed, went to ER gave fluid 3 liters, 2 bags of antibiotics (IV), 2 days in a row. Hospital said I had (Cellulitis) given (Keflex antibiotics) due to shot. Arm where the vaccination was given still is tender at times-And he has lost 56 lbs. for what I don't know.
Age: 17.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Oedema, Pyrexia, Vomiting
Clinical narrative: High fever of (102.8 degrees) head hurt, arm was red, hot, swollen, and could not lift, hurt underarm along the arm pit and left lung area, vomiting pain in stomach, sic for 4 days could not even stand. Head, arm and lung area hurts so bad! Sick for 4 days in bed, went to ER gave fluid 3 liters, 2 bags of antibiotics (IV), 2 days in a row. Hospital said I had (Cellulitis) given (Keflex antibiotics) due to shot. Arm where the vaccination was given still is tender at times-And he has lost 56 lbs. for what I don't know.
Age: 17.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Anorexia, Cellulitis, Cough, Dehydration, Erythema
Clinical narrative: High fever of (102.8 degrees) head hurt, arm was red, hot, swollen, and could not lift, hurt underarm along the arm pit and left lung area, vomiting pain in stomach, sic for 4 days could not even stand. Head, arm and lung area hurts so bad! Sick for 4 days in bed, went to ER gave fluid 3 liters, 2 bags of antibiotics (IV), 2 days in a row. Hospital said I had (Cellulitis) given (Keflex antibiotics) due to shot. Arm where the vaccination was given still is tender at times-And he has lost 56 lbs. for what I don't know.
Age: 17.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Headache, Injection site warmth, Pain, Pharyngitis, Pyrexia
Clinical narrative: High fever of (102.8 degrees) head hurt, arm was red, hot, swollen, and could not lift, hurt underarm along the arm pit and left lung area, vomiting pain in stomach, sic for 4 days could not even stand. Head, arm and lung area hurts so bad! Sick for 4 days in bed, went to ER gave fluid 3 liters, 2 bags of antibiotics (IV), 2 days in a row. Hospital said I had (Cellulitis) given (Keflex antibiotics) due to shot. Arm where the vaccination was given still is tender at times-And he has lost 56 lbs. for what I don't know.
Age: 17.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Rhinitis, Swelling
Clinical narrative: High fever of (102.8 degrees) head hurt, arm was red, hot, swollen, and could not lift, hurt underarm along the arm pit and left lung area, vomiting pain in stomach, sic for 4 days could not even stand. Head, arm and lung area hurts so bad! Sick for 4 days in bed, went to ER gave fluid 3 liters, 2 bags of antibiotics (IV), 2 days in a row. Hospital said I had (Cellulitis) given (Keflex antibiotics) due to shot. Arm where the vaccination was given still is tender at times-And he has lost 56 lbs. for what I don't know.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Ecchymosis, Injection site hypersensitivity, Nausea, Oedema
Clinical narrative: Nausea, local redness, edema and ecchymosis, dizziness that evening until 11/15/05.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pruritus, Stridor, Urticaria
Clinical narrative: Pneumovax given 11-10-05 developed redness around injection site, hives chest, neck, stridor, itching eyes, nose, throat. Pt self medicated with Benadryl. Seen 11/11/05 at PCH. Rx Medrol dose pack.
Sex: M
Vaccine: HEP
Symptoms: Abdominal discomfort, Abdominal pain, Fat tissue increased, Hyperkalaemia, Infection
Clinical narrative: This case was reported by a physician and described the occurrence of abdominal infection in a male subject of unspecified age who was vaccinated with hepatitis b vaccine (Engerix B) for prophylaxis. The subjects history included abdominal abscess, appendicitis, enterocutaneous fistula, ischemic colitis, lymphadenitis, post surgical wound infection and wound evisceration. Previous or concurrent vaccination included Engerix B vaccine intramuscular given on Feb 8 2005, march 10 2005 and August 16 2005. On June 2 2005 the subject received 3rd dose of Engerix B 40 mcg, intramuscular. On Aug 5 2005, 2 months after vaccination, the subject developed hyperpotassemia and was hospitalized and and was discharged on Aug 13-14 2005. On Aug 6 2005, the subject developed abdominal pain. On the same day, he was admitted in the hospital for a study. On Aug 6 2005. leucocytosis was objectified. An abdominal CT scan was performed and showed mesenteric fat infiltration in the region of the ileocolic anastomosis, with unspecified thickness of the wall of the colic side of the anastomosis. The subject was treated with ciprofloxacin IV every 8 hours from Aug 6 to 10 2005 an till Aug 17 continued with ciprofloxacin PO. On Aug 8 2005, the abdominal pain abated, the subject recovered and was discharges from hospital. The investigator updated the patient status and Engerix dosing schedule. On June 20 2005, the subject attended a scheduled protocol visit and did not receive Engerix B. The fourth and last dose of Engerix B was administered on Aug 16 2005. The patient did not attend the protocol visit schedule for mid Sept 2005. On Sept 21 2005 the subject died of abdominal infection and septic shock. The investigator considered the event not related to study drug. Further information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Leukocytosis, Sepsis, Shock, White blood cell count increased
Clinical narrative: This case was reported by a physician and described the occurrence of abdominal infection in a male subject of unspecified age who was vaccinated with hepatitis b vaccine (Engerix B) for prophylaxis. The subjects history included abdominal abscess, appendicitis, enterocutaneous fistula, ischemic colitis, lymphadenitis, post surgical wound infection and wound evisceration. Previous or concurrent vaccination included Engerix B vaccine intramuscular given on Feb 8 2005, march 10 2005 and August 16 2005. On June 2 2005 the subject received 3rd dose of Engerix B 40 mcg, intramuscular. On Aug 5 2005, 2 months after vaccination, the subject developed hyperpotassemia and was hospitalized and and was discharged on Aug 13-14 2005. On Aug 6 2005, the subject developed abdominal pain. On the same day, he was admitted in the hospital for a study. On Aug 6 2005. leucocytosis was objectified. An abdominal CT scan was performed and showed mesenteric fat infiltration in the region of the ileocolic anastomosis, with unspecified thickness of the wall of the colic side of the anastomosis. The subject was treated with ciprofloxacin IV every 8 hours from Aug 6 to 10 2005 an till Aug 17 continued with ciprofloxacin PO. On Aug 8 2005, the abdominal pain abated, the subject recovered and was discharges from hospital. The investigator updated the patient status and Engerix dosing schedule. On June 20 2005, the subject attended a scheduled protocol visit and did not receive Engerix B. The fourth and last dose of Engerix B was administered on Aug 16 2005. The patient did not attend the protocol visit schedule for mid Sept 2005. On Sept 21 2005 the subject died of abdominal infection and septic shock. The investigator considered the event not related to study drug. Further information has been requested.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pain
Clinical narrative: Employee states after receiving flu shot at 11:30 am 11/15/05 she felt fine until 6pm or 7pm. Then she ached all over and had trouble exhaling. This lasted 1 hr. She took a sleeping pill and when she woke, she was fine.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Oral intake reduced, Pyrexia
Clinical narrative: High fever, reduced by mouth intake, increased fussiness since receiving the shots.
Age: 1.08
Sex: F
Vaccine: HIBV, PNC, VARCEL
Symptoms: Crying, Irritability, Lethargy, Pyrexia, Screaming
Clinical narrative: Elevated temp 104.2 after 2 hours, 102 48-72 hours, lethargic, fussy, screamed 72 hours, vomited x 3.
Age: 1.08
Sex: F
Vaccine: HIBV, PNC, VARCEL
Symptoms: Vomiting
Clinical narrative: Elevated temp 104.2 after 2 hours, 102 48-72 hours, lethargic, fussy, screamed 72 hours, vomited x 3.
Age: 0.34
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever to 103.7;seizure
Age: 53.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site inflammation
Clinical narrative: Patient called on 11/3 in the AM reporting redness, inflammation and warmth to touch in RA at site of PPV23 injection.  Admits never received PPV23 before.  Instructed by RN to come to the health department for assessment or make an appointment with private MD.  RN did not see or assess patient.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Insomnia, Nausea, Pain
Clinical narrative: 11/9/2005:  Patient states about 6 hours after receiving injection she began hurting under her arm and having nausea.  Took Darvocet for pain.  Was unable to sleep.  Still complained of soreness and nausea today.  Denies arm being red or hot to the touch.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Lymphadenopathy
Clinical narrative: rash at the site of injection  axillary lymph node swelling
Age: 11.0
Sex: F
Vaccine: FLUX
Symptoms: Convulsion
Clinical narrative: Focal seizure  2 hours after vaccine given... partial seizure 24 hours after give
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Pruritus, Rash, Swelling
Clinical narrative: The Flu Shot was given on 11/9/05 @ 10:00 AM in the Left Deltoid muscle without difficulty. That evening client reported she had ichy skin in left ear lobe and left side of neck under the chin. Then the next day awaken with a swollen left earlobe and non-raised rash in left nesk area the size of a 50 cent piece and complains of itchyness in this area.I administered 25 mg of Benadryl and sent her back to work. Two hours later I called her to see how she was doing and she informed me she was going home because she was to tired to work. That night she reports that the entire left ear became swoollen and ichy. Her rash also got larger. She applied a cream to the ear and took a motrin tablet her friend gave her. She does not remember what the name of the cream was.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patfient received the PPV23 vaccine on 11/14/05 sc left arm;  site became extremely red and painful the evening of 11/16/05.  Pt says she put ice on it yesterday.  This is patients second pneumococcal vaccine.  The first was given greater than 5 years ago.  The flu shot was also given at the same time IM, left arm also, as patient had surgery in the right arm.  Patient not in any acute distress.  She was concerned about the redness since she has never had any problems from receiving the flu shot every year.  She will continue cool compresses, take alleve as needed.  Recommended to call her PCP if redness worsens.
Age: 2.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Convulsion, Rash
Clinical narrative: Approximately 24 hours after receiving flu vaccine patient had a seizure lasting 20 seizures.  It was a full tonic-clonic seizure.  At the hospital the Pediatrician noticed a rash on patient's trunk and hand (I observed this also).  She did a throat culture for strep and stated that this was not an adverse reaction to the vaccine.  Additionally a resident at the ER indicated it was not an adverse reaction to the vaccine and the patient's pediatrician stated it was not an expected reaction but that it would be reported to FDA/CDC.
Age: 2.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Convulsion
Clinical narrative: Approximately 24 hours after receiving flu vaccine patient had a seizure lasting 20 seizures.  It was a full tonic-clonic seizure.  At the hospital the Pediatrician noticed a rash on patient's trunk and hand (I observed this also).  She did a throat culture for strep and stated that this was not an adverse reaction to the vaccine.  Additionally a resident at the ER indicated it was not an adverse reaction to the vaccine and the patient's pediatrician stated it was not an expected reaction but that it would be reported to FDA/CDC.