chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: International normalised ratio normal, Lip swelling, Local swelling, Metabolic function test normal, Neck pain
Clinical narrative: Patient AF reported receipt of annual influenza vaccine on Nov 5, 2012 (FLUZONE, Lot # UH713AA). Approximately 1 hour later her tongue was swelling with left sided facial swelling, her left arm was numb and hurt (flu shot given in left upper deltoid) and she had large bright red swollen area to her neck, upper chest/throat region with squeezing pain to neck and left upper chest. She did admit to some shortness of breath but was unsure if due to anxiety or chest pain. She presented to nearby ER, was given oral BENADRYL and 1 hour later all symptoms except mild puffiness to left side of face had resolved. She was observed for 6 hours without sequelae and resolution of all symptoms. Of interest was a note on 4/15/2013 where she presented to ER for chest pain with left arm heaviness and facial paresthesia while sitting at her desk. Pain lasted <6 minutes 3/10 pain scale with about 6 reoccurrences 24 hours after an upper body workout. She described the intermittent paresthesia to left cheek as swelling without other systemic symptoms. She was pain and paresthesia free on exam and diagnosed with possible musculoskeletal chest pain (spasm vs costochondritis) and anxiety. Follow up exam 4/19/2013 showed negative labs (CK, Troponin T, CKMB, B12, folate, BMP, Iron panel, ferritin, CBC Kw/diff, D-Dimer, PT-INR); normal EKG and CT head/brain w/o contrast. Prior to next flu vaccination, she was referred to allergy clinic on 12/31/2013 for skin prick test to FLUZONE (Lot# UH907AD). Provider's document normal spirometry and negative skin prick test and she was given full dose of FLUZONE, observed for 30 minutes and released. However she reported her face felt full on the left side similar to 2012 reaction (tingling and swelling sensation to tongue/left side face) and she was monitored for another 30 minutes in waiting room. She advised she self-treated herself with oral BENADRYL. Providers note she left after 1 hour without incidence. She was diagnosed with possible non-anaphylactic adverse reaction to flu vaccine and probably oral allergy syndrome. She was instructed to continue with ACIP/CDC guidelines for yearly flu vaccinations. (AHLTA note 12/31/2013). In April 2014 evaluation by allergy clinic for possible food allergies noted similar complaints of left facial numbness after eating black and white cookie and had had similar symptoms when turning her head to the side in March 2014. She reported randomly that her tongue or lips felt swollen and taste buds looked red with/without foot intake. She also noted blisters after taking combo pill of magnesium and Vit D supplement that eased with oral BENADRYL (see ALHTA note 4/29/2014). She was diagnosed with food reaction after food test allergy panel was negative and allergic rhinitis. To follow up for further allergy testing supplement ingredients. In 2014 she requested an exemption to influenza vaccine thru committee and referred to Immunization Healthcare Branch for further evaluation.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Oral allergy syndrome, Pain in extremity, Paraesthesia, Paraesthesia oral, Pharyngeal oedema
Clinical narrative: Patient AF reported receipt of annual influenza vaccine on Nov 5, 2012 (FLUZONE, Lot # UH713AA). Approximately 1 hour later her tongue was swelling with left sided facial swelling, her left arm was numb and hurt (flu shot given in left upper deltoid) and she had large bright red swollen area to her neck, upper chest/throat region with squeezing pain to neck and left upper chest. She did admit to some shortness of breath but was unsure if due to anxiety or chest pain. She presented to nearby ER, was given oral BENADRYL and 1 hour later all symptoms except mild puffiness to left side of face had resolved. She was observed for 6 hours without sequelae and resolution of all symptoms. Of interest was a note on 4/15/2013 where she presented to ER for chest pain with left arm heaviness and facial paresthesia while sitting at her desk. Pain lasted <6 minutes 3/10 pain scale with about 6 reoccurrences 24 hours after an upper body workout. She described the intermittent paresthesia to left cheek as swelling without other systemic symptoms. She was pain and paresthesia free on exam and diagnosed with possible musculoskeletal chest pain (spasm vs costochondritis) and anxiety. Follow up exam 4/19/2013 showed negative labs (CK, Troponin T, CKMB, B12, folate, BMP, Iron panel, ferritin, CBC Kw/diff, D-Dimer, PT-INR); normal EKG and CT head/brain w/o contrast. Prior to next flu vaccination, she was referred to allergy clinic on 12/31/2013 for skin prick test to FLUZONE (Lot# UH907AD). Provider's document normal spirometry and negative skin prick test and she was given full dose of FLUZONE, observed for 30 minutes and released. However she reported her face felt full on the left side similar to 2012 reaction (tingling and swelling sensation to tongue/left side face) and she was monitored for another 30 minutes in waiting room. She advised she self-treated herself with oral BENADRYL. Providers note she left after 1 hour without incidence. She was diagnosed with possible non-anaphylactic adverse reaction to flu vaccine and probably oral allergy syndrome. She was instructed to continue with ACIP/CDC guidelines for yearly flu vaccinations. (AHLTA note 12/31/2013). In April 2014 evaluation by allergy clinic for possible food allergies noted similar complaints of left facial numbness after eating black and white cookie and had had similar symptoms when turning her head to the side in March 2014. She reported randomly that her tongue or lips felt swollen and taste buds looked red with/without foot intake. She also noted blisters after taking combo pill of magnesium and Vit D supplement that eased with oral BENADRYL (see ALHTA note 4/29/2014). She was diagnosed with food reaction after food test allergy panel was negative and allergic rhinitis. To follow up for further allergy testing supplement ingredients. In 2014 she requested an exemption to influenza vaccine thru committee and referred to Immunization Healthcare Branch for further evaluation.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Prothrombin time normal, Rhinitis allergic, Serum ferritin normal, Skin test negative, Swelling face
Clinical narrative: Patient AF reported receipt of annual influenza vaccine on Nov 5, 2012 (FLUZONE, Lot # UH713AA). Approximately 1 hour later her tongue was swelling with left sided facial swelling, her left arm was numb and hurt (flu shot given in left upper deltoid) and she had large bright red swollen area to her neck, upper chest/throat region with squeezing pain to neck and left upper chest. She did admit to some shortness of breath but was unsure if due to anxiety or chest pain. She presented to nearby ER, was given oral BENADRYL and 1 hour later all symptoms except mild puffiness to left side of face had resolved. She was observed for 6 hours without sequelae and resolution of all symptoms. Of interest was a note on 4/15/2013 where she presented to ER for chest pain with left arm heaviness and facial paresthesia while sitting at her desk. Pain lasted <6 minutes 3/10 pain scale with about 6 reoccurrences 24 hours after an upper body workout. She described the intermittent paresthesia to left cheek as swelling without other systemic symptoms. She was pain and paresthesia free on exam and diagnosed with possible musculoskeletal chest pain (spasm vs costochondritis) and anxiety. Follow up exam 4/19/2013 showed negative labs (CK, Troponin T, CKMB, B12, folate, BMP, Iron panel, ferritin, CBC Kw/diff, D-Dimer, PT-INR); normal EKG and CT head/brain w/o contrast. Prior to next flu vaccination, she was referred to allergy clinic on 12/31/2013 for skin prick test to FLUZONE (Lot# UH907AD). Provider's document normal spirometry and negative skin prick test and she was given full dose of FLUZONE, observed for 30 minutes and released. However she reported her face felt full on the left side similar to 2012 reaction (tingling and swelling sensation to tongue/left side face) and she was monitored for another 30 minutes in waiting room. She advised she self-treated herself with oral BENADRYL. Providers note she left after 1 hour without incidence. She was diagnosed with possible non-anaphylactic adverse reaction to flu vaccine and probably oral allergy syndrome. She was instructed to continue with ACIP/CDC guidelines for yearly flu vaccinations. (AHLTA note 12/31/2013). In April 2014 evaluation by allergy clinic for possible food allergies noted similar complaints of left facial numbness after eating black and white cookie and had had similar symptoms when turning her head to the side in March 2014. She reported randomly that her tongue or lips felt swollen and taste buds looked red with/without foot intake. She also noted blisters after taking combo pill of magnesium and Vit D supplement that eased with oral BENADRYL (see ALHTA note 4/29/2014). She was diagnosed with food reaction after food test allergy panel was negative and allergic rhinitis. To follow up for further allergy testing supplement ingredients. In 2014 she requested an exemption to influenza vaccine thru committee and referred to Immunization Healthcare Branch for further evaluation.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue, Tongue disorder, Troponin T normal, Vitamin B12 normal
Clinical narrative: Patient AF reported receipt of annual influenza vaccine on Nov 5, 2012 (FLUZONE, Lot # UH713AA). Approximately 1 hour later her tongue was swelling with left sided facial swelling, her left arm was numb and hurt (flu shot given in left upper deltoid) and she had large bright red swollen area to her neck, upper chest/throat region with squeezing pain to neck and left upper chest. She did admit to some shortness of breath but was unsure if due to anxiety or chest pain. She presented to nearby ER, was given oral BENADRYL and 1 hour later all symptoms except mild puffiness to left side of face had resolved. She was observed for 6 hours without sequelae and resolution of all symptoms. Of interest was a note on 4/15/2013 where she presented to ER for chest pain with left arm heaviness and facial paresthesia while sitting at her desk. Pain lasted <6 minutes 3/10 pain scale with about 6 reoccurrences 24 hours after an upper body workout. She described the intermittent paresthesia to left cheek as swelling without other systemic symptoms. She was pain and paresthesia free on exam and diagnosed with possible musculoskeletal chest pain (spasm vs costochondritis) and anxiety. Follow up exam 4/19/2013 showed negative labs (CK, Troponin T, CKMB, B12, folate, BMP, Iron panel, ferritin, CBC Kw/diff, D-Dimer, PT-INR); normal EKG and CT head/brain w/o contrast. Prior to next flu vaccination, she was referred to allergy clinic on 12/31/2013 for skin prick test to FLUZONE (Lot# UH907AD). Provider's document normal spirometry and negative skin prick test and she was given full dose of FLUZONE, observed for 30 minutes and released. However she reported her face felt full on the left side similar to 2012 reaction (tingling and swelling sensation to tongue/left side face) and she was monitored for another 30 minutes in waiting room. She advised she self-treated herself with oral BENADRYL. Providers note she left after 1 hour without incidence. She was diagnosed with possible non-anaphylactic adverse reaction to flu vaccine and probably oral allergy syndrome. She was instructed to continue with ACIP/CDC guidelines for yearly flu vaccinations. (AHLTA note 12/31/2013). In April 2014 evaluation by allergy clinic for possible food allergies noted similar complaints of left facial numbness after eating black and white cookie and had had similar symptoms when turning her head to the side in March 2014. She reported randomly that her tongue or lips felt swollen and taste buds looked red with/without foot intake. She also noted blisters after taking combo pill of magnesium and Vit D supplement that eased with oral BENADRYL (see ALHTA note 4/29/2014). She was diagnosed with food reaction after food test allergy panel was negative and allergic rhinitis. To follow up for further allergy testing supplement ingredients. In 2014 she requested an exemption to influenza vaccine thru committee and referred to Immunization Healthcare Branch for further evaluation.
Age: 29.0
Sex: M
Vaccine: FLUN4
Symptoms: Papule, Pseudofolliculitis barbae, Radioallergosorbent test, Rash, Rash pruritic
Clinical narrative: On 10/7/2014, he received his annual Influenza vaccination with FLUMIST. He denied any problems for the next two days. Approximately 48-72 hours after vaccination (day 2-3) he noticed a 1x2 inch pimply like flat rash under his left chest wall/breast area that itched. He is dark skinned so he was unsure if red or not. He denied any papules, vesicles or oozing from the site, no fever, myalgia, arthralgia, headaches, runny nose or any other systemic symptoms. He reported no trauma, new clothing, detergents, deodorants, lotions, creams, does not shave chest hair or used/exposed to any new foods or environmental exposures. He reported over next few days this itchy rash spread in patches to right side of chest, onto his back under right scapula, and onto right antecubital. He denied this rash spreading to his hands, feet or lower torso below waist or legs. He reported he was self-treating with topical coconut oil. He reported one provider thought he had PFB on his neck. He presented to medical on 10/21/2014 where provider documented skin eruption to his upper chest, back and abdomen as some flesh colored papules with no pustules or vesicles. He was diagnosed with "skin symptoms" and prescribed Triamcinolone and Cetirizine HCL and referred to Allergy clinic. Allergy clinic referred to IHB for further evaluation.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered
Clinical narrative: FLUARIX dose expired that was given to patient.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Brain oedema, Confusional state, Dizziness, Encephalitis, Eye swelling
Clinical narrative: Encephalitis, brain swollen, dizzy, confused, tired, headache, swollen face and eyes.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Swelling face
Clinical narrative: Encephalitis, brain swollen, dizzy, confused, tired, headache, swollen face and eyes.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered
Clinical narrative: FLUARIX dose expired that was given to pt.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Patient came in with hives. One at injection site and multiple all over body. Given BENADRYL in office, treated with prednisolone and ranitidine for hives.
Age: 1.44
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, PNC13
Symptoms: Blood glucose normal, Body temperature increased, Crying, Eye movement disorder, Somnolence
Clinical narrative: On 12/10 at around 0800 child had a 30 second tonic-clonic episode w/ eyes rolling back and afterwards was sleepy/drowsy. Paramedics were called and brought child to ER where she was crying and appropriate. Temp 38 degrees rectal, NL blood sugar. No other labs/tests. D/C home.
Age: 1.44
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, PNC13
Symptoms: Tonic clonic movements
Clinical narrative: On 12/10 at around 0800 child had a 30 second tonic-clonic episode w/ eyes rolling back and afterwards was sleepy/drowsy. Paramedics were called and brought child to ER where she was crying and appropriate. Temp 38 degrees rectal, NL blood sugar. No other labs/tests. D/C home.
Age: 77.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site plaque, Injection site pruritus
Clinical narrative: 3 x 9" pink, itchy plaque Lt upper arm.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pruritus, Urticaria, Vomiting
Clinical narrative: Urticaria pruritus and nausea/vomiting. Diphenhydramine, methylprednisolone.
Age: 72.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Drooling, Dyspnoea, Lip swelling, Swollen tongue
Clinical narrative: Pt's lips and tongue swelled up and pt had trouble breathing. Was drooling, pt had shots about noon, then took nap. Awoke 1630 with symptoms.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Rash, burning, swelling, pain radiates from upper arm to elbow. Patient reported this on 12/11/14 approx 6:30 pm.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Pain
Clinical narrative: Developed a headache that evening. Complained aboout everything hurting. Head still hurting next morning.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Epistaxis, Platelet count decreased
Clinical narrative: Nosebleed. Platelet loss.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient presented with a red swollen area about 3" x 5" with a raised light area 2" x 3" in the center. Slightly warm to the touch. Patient had marked outer areas to measure movement. Advised to use ice pack and OTC pain medication.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Adverse reaction at injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Local reaction, Tenderness
Clinical narrative: 2" x 3" injection site local reaction. Slightly raised and light pink. Patient reports sore to the touch 2 days after injection.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age and unknown gender. The patient's pertinent medical history was not reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored PROQUAD, (dose/frequency: 0.5 ml) subcutaneously (SQ). No adverse effects were reported. No product quality complaint (PQC) was reported for PROQUAD. This case is linked to case # 1412USA005653 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age and unknown gender. The patient's pertinent medical history was not reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored VARIVAX (Merck). No adverse effects were reported. No product quality complaint (PQC) was reported VARIVAX (Merck). This case is linked to case # 1412USA004781 (same reporter link). Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient with allergy to penicillin and allergy to sulfa. On 01-DEC-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K009874, expiration date 15-MAR-2016, dose and frequency not reported, intramuscularly). No concomitant therapy was reported. On 02-DEC-2014 the patient experienced redness and swelling of her left arm after receiving PNEUMOVAX 23 described as occurring on the opposite side of the arm from the injection site in a subcutaneous area despite the injection being given intramuscularly. The pharmacist additionally reported that the patient could hardly move the arm as a result on 02-DEC-2014. There was no treatment given for the events. The outcomes of the events were reported as not recovered. The patient sought medical attention by an unspecified physician office visit. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received 27-OCT-2014 from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received on 13-NOV-2014 from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 21-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unknown age and gender. The nurse reported that an unknown number of doses of VARIVAX (Merck) (dose, lot# and route not reported) that were improperly stored (outside of the range specified in the prescribing information) might have been administered. VARIVAX (Merck) was experienced freezer fluctuations of 7-9 F and possibly temperatures of 14-15F for 24 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: See attached.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Discomfort, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: See attached.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Swelling
Clinical narrative: See attached.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. On 29-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (Batch, Lot # reported as K008886, expiration date: 20-SEP-2015) .65 ml, subcutaneous. On 13-NOV-2014, 16 days after onset of therapy the patient developed a cold sore on her lip. The pharmacist stated that the patient would be treating the cold sore with an unspecified over the counter cold sore medication. No further information provided. None Lab Diagnostic Studies were performed. The outcome of cold sore on her lip was reported as not recovered. It was also reported that the patient was assessed by pharmacist. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Contusion, Platelet count decreased
Clinical narrative: This spontaneous report as received from a patient's mother refers to the 17 year old female patient with penicillin allergy and no pertinent medical history. On 05-MAY-2014 the patient was vaccinated with the first dose of GARDASIL (lot # J013324, expiration date 12-FEB-2016), route unspecified. On an unknown date in 2014 the patient was vaccinated with the second dose of GARDASIL (lot # K001500, expiration date 06-NOV-2016), route unspecified. No concomitant medication. On approximately 19-MAY-2014 (within first two weeks of first dose) the patient experienced multiple areas of bruising including on her legs, ankles and arms. The patient was diagnosed with Immune thrombocytopenic purpura (ITP) or "idiopathic thrombocytopenia" on 20-AUG-2014 when she went for a normal check-up before going off to college. The patient's doctor said the patient's "platelets were dangerously low". It was the patient's mother's decision not to have her daughter receive the last dose of GARDASIL on 11-JUL-2014. The patient's mother said the patient did not have any of the above issues before being injected with GARDASIL. The patient received high dose prednisone as treatment. The patient now "must have weekly blood work done" and must go to the hematologist weekly. The events outcome was unknown. Upon internal review, ITP or "idiopathic thrombocytopenia" was considered to be medically significant. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Contusion, Immune thrombocytopenic purpura, Incomplete course of vaccination, Platelet count decreased
Clinical narrative: This spontaneous report as received from a patient's mother refers to the 17 year old female patient with penicillin allergy and no pertinent medical history. On 05-MAY-2014 the patient was vaccinated with the first dose of GARDASIL (lot # J013324, expiration date 12-FEB-2016), route unspecified. On an unknown date in 2014 the patient was vaccinated with the second dose of GARDASIL (lot # K001500, expiration date 06-NOV-2016), route unspecified. No concomitant medication. On approximately 19-MAY-2014 (within first two weeks of first dose) the patient experienced multiple areas of bruising including on her legs, ankles and arms. The patient was diagnosed with Immune thrombocytopenic purpura (ITP) or "idiopathic thrombocytopenia" on 20-AUG-2014 when she went for a normal check-up before going off to college. The patient's doctor said the patient's "platelets were dangerously low". It was the patient's mother's decision not to have her daughter receive the last dose of GARDASIL on 11-JUL-2014. The patient's mother said the patient did not have any of the above issues before being injected with GARDASIL. The patient received high dose prednisone as treatment. The patient now "must have weekly blood work done" and must go to the hematologist weekly. The events outcome was unknown. Upon internal review, ITP or "idiopathic thrombocytopenia" was considered to be medically significant. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood test, Burning sensation, Erythema, Headache, Injected limb mobility decreased
Clinical narrative: Redness, warmth, tenderness, swelling to left deltoid. Treated with IV antibiotics for cellulitis.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site pain, Pruritus, Pyrexia, Swelling, Ultrasound scan
Clinical narrative: Redness, warmth, tenderness, swelling to left deltoid. Treated with IV antibiotics for cellulitis.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, tenderness, swelling to left deltoid. Treated with IV antibiotics for cellulitis.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Ultrasound scan
Clinical narrative: Redness, warmth, tenderness, swelling to left deltoid. Treated with IV antibiotics for cellulitis.
Sex: U
Vaccine: RV5, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 02-DEC-2014, the patient was vaccinated with ROTATEQ suspension, 2 ml/ once, oral (lot number and expiration date were not reported). Medical assistant reported that patient received an expired dose of ROTATEQ suspension. No adverse events were reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure fluctuation, Headache
Clinical narrative: Pt. reported hospitalization - reported to manufacturer.
Age: 78.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Unevaluable event
Clinical narrative: Pt. reported hospitalization - reported to manufacturer.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: Left shoulder 11/25 given seasonal influenza vaccine by ER manager to left deltoid high on the deltoid.  Severe pain with injection.  Pain progressively getting worse x3 weeks with decreased ROM. As of 12/11/14 unable to lift left arm up to do my hair.  To date pain unrelieved by Motrin and Voltaren cream. 12/11/14 Notified employee health and risk manager of symptoms and pain from vaccine adverse reaction. No forms filled out. Discussed with ER manager my symptoms and pain.  Per ER manager she too thought she had given the vaccine high up on my deltoid. X-ray 4view left shoulder order by Dr. was normal. MRI without contrast left shoulder was order by Dr. showing edema in the supraspinatus and infraspinatus muscle bodies left shoulder. US left shoulder (quick view) performed no report Consult with Dr. and exam by Dr.  Followed by Kenalog injection to left shoulder which provided minimal relief. Arranged fu appt for 12/12/14 with Dr.  Placed on Medrol dose pak and Aleve. Pain 8/10 at night 12/11/14 causing me not to be able to sleep. Unable to fully perform job duties, care for my young children 12/12/14.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Insomnia, Muscle oedema, Nuclear magnetic resonance imaging abnormal, Ultrasound scan, X-ray limb normal
Clinical narrative: Left shoulder 11/25 given seasonal influenza vaccine by ER manager to left deltoid high on the deltoid.  Severe pain with injection.  Pain progressively getting worse x3 weeks with decreased ROM. As of 12/11/14 unable to lift left arm up to do my hair.  To date pain unrelieved by Motrin and Voltaren cream. 12/11/14 Notified employee health and risk manager of symptoms and pain from vaccine adverse reaction. No forms filled out. Discussed with ER manager my symptoms and pain.  Per ER manager she too thought she had given the vaccine high up on my deltoid. X-ray 4view left shoulder order by Dr. was normal. MRI without contrast left shoulder was order by Dr. showing edema in the supraspinatus and infraspinatus muscle bodies left shoulder. US left shoulder (quick view) performed no report Consult with Dr. and exam by Dr.  Followed by Kenalog injection to left shoulder which provided minimal relief. Arranged fu appt for 12/12/14 with Dr.  Placed on Medrol dose pak and Aleve. Pain 8/10 at night 12/11/14 causing me not to be able to sleep. Unable to fully perform job duties, care for my young children 12/12/14.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Influenza virus test negative, Muscle twitching, Pyrexia, Streptococcus test negative, Vomiting
Clinical narrative: Extremely high fever (105.8), twitching, vomiting.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Confusional state, Crying, Lethargy, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Fever, crying, stiffness, confusion and lethargy.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness at injection site. Slight tenderness to touch.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pain, Paraesthesia oral, Photosensitivity reaction, Vomiting
Clinical narrative: Complaining of acute onset photosensitivity, body aches, nausea, and one episode of vomiting and tingling around his lips and mouth. No signs or symptoms of hives or swelling at site. No complaints of difficulty breathing or dizziness. Patient refused administration of epinephrine or calling emergency.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot
Clinical narrative: Participant stated she was warm and dizzy. BP 135, P 65. Denied difficulty breathing and vitals monitored.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness, Skin reaction
Clinical narrative: Participant had skin reaction. Fingers are numb and arm feels like jello per participant. No respiratory issues. She took Tylenol and Benadryl at facility.
Age: 40.0
Sex: M
Vaccine: FLUN4, MMR
Symptoms: Urticaria
Clinical narrative: Hives on chest & thighs.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Fall, Hyperhidrosis, Nervousness, Pallor
Clinical narrative: Vaccinated - 15-20 minutes later participant fell to the floor. Witness witnessed a few seconds of seizure. Participant states he felt nervous and saw "black sparkles." Pulse 75, slightly sweaty, pale. Gave 500 ml Gatorade, cold pack to back of head. After 15 minutes pulse was 70 and strong. He was less sweaty.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: Vaccinated - 15-20 minutes later participant fell to the floor. Witness witnessed a few seconds of seizure. Participant states he felt nervous and saw "black sparkles." Pulse 75, slightly sweaty, pale. Gave 500 ml Gatorade, cold pack to back of head. After 15 minutes pulse was 70 and strong. He was less sweaty.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain
Clinical narrative: Patient was given injection at 10:35am. He returned to work and then reported back at 1:30pm, stating he had soreness from site where injection was given and that it traveled up his neck and stopped at the site right behind his ear. Patient had stated he had received vaccine in the past with no reactions. Patient did not present with any itching, shortness of breath, redness, or swollen. He was able to move it side to side
Age: 18.0
Sex: M
Vaccine: YF
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient given Yellow Fever vaccine 4 days following administration of a Varicella vaccine.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Disturbance in attention
Clinical narrative: Soreness at right side prior to flu shot. Hard to concentrate when doing computer work. Applied ice to shoulder for 30 minutes. No Epi administered. Had Patient move head side to side successfully. No redness, itching, and swallowness at site. Participant states symptoms have subsided by 3:00 PM. Feeling fine.
Age: 0.58
Sex: F
Vaccine: FLUX
Symptoms: Abnormal behaviour, Decreased eye contact, Muscle twitching, Pyrexia
Clinical narrative: 103° fever very hard to bring down. Twitching. Fussy. Odd, distant behavior. Fever lasted 3 days. Behavior continues to be odd, won't look when called or make eye contact. Tylenol and Advil were used.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Dry skin, Heart rate increased, Immediate post-injection reaction, Musculoskeletal stiffness
Clinical narrative: Participant immediately stiffened in chair, eyes open, pulse rapid. Moved to floor with assistance of two co-workers. Remained conscious. Ice applied to forehead and neck, legs elevated, BP 140/80, P 100. Skin - cool and clammy. Participant remained conscious, color pale. After 15 minutes, sat up and drank some water. Color improved, pink, skin warm and dry. After 20 minutes, assisted to chair, drank an Element H20. Requested some food. At 1 bite of bar and vomited 3 x @ 40 minutes. After initial incident, continued to observe. Patient did relate that this has occurred several times in past. BP 140/90, P 80 @ 12:15 PM. Alert and oriented- active- desired to return to work.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor, Skin warm, Vomiting
Clinical narrative: Participant immediately stiffened in chair, eyes open, pulse rapid. Moved to floor with assistance of two co-workers. Remained conscious. Ice applied to forehead and neck, legs elevated, BP 140/80, P 100. Skin - cool and clammy. Participant remained conscious, color pale. After 15 minutes, sat up and drank some water. Color improved, pink, skin warm and dry. After 20 minutes, assisted to chair, drank an Element H20. Requested some food. At 1 bite of bar and vomited 3 x @ 40 minutes. After initial incident, continued to observe. Patient did relate that this has occurred several times in past. BP 140/90, P 80 @ 12:15 PM. Alert and oriented- active- desired to return to work.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness
Clinical narrative: Numbness and weakness both legs. Start in feet up to knees. Cleared on 4-5 days. Guillain-Barre syndrome diagnosed by hospitalist.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Local swelling, Pyrexia
Clinical narrative: Pt described fever and swelling of extremities for 2-3 days.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Stymptoms: Vomiting. Course: About 3 hours beginning approx. midnight of day of vaccination. Treatment: None.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: Blisters and pain, went to hospital and doctor sait it was shingles caused from shot. Dr gave Motrin and antiviral acyclovir and will pick up gabapentin today.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: C/O stiffness, sharp shooting paints that started minutes to hours after injection, pain has continued since. There is no swelling or redness. Area just posterior to deltoid is painful to touch.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety disorder, Bipolar disorder, Depression, Sensation of heaviness
Clinical narrative: Participant received a flu shot and while waiting for the reaction, started complaining of heaviness in both arms. Call made to EMS waited for the ambulance, participant stated "feeling better." Monitored by nurse, EMS took vitals BP 130/80, P 85 reported. Bipolar, depression, axienty disorders. Glucose 88 mg/dL, less than 2 second capillary refill.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Client states she felt dizzy and sat on the bathroom floor. BP 110/76, P 58, Resp. 18. Alert and oriented and talking to staff. No sign of distress noted. Client offered fluid. Call made to site contact and notified. 14:30 PM site contact called EMS.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Large, red patch a couple inches in diameter around injection site.  Physician diagnosed as cellulitis.  Patient started Bactrim DS 1bid x10d on 12/12/2014.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Apnoea, Erythema
Clinical narrative: Dupp nea, well circumscribed local redness.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: L arm persistent pain that radiates and causes immobility.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: L arm persistent pain that radiates and causes immobility.
Age: 0.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, MNQ
Symptoms: Contusion, Erythema, Gait disturbance, Pyrexia, Swelling
Clinical narrative: Fever 102; swelling/redness/bruising to leg; won't walk on leg.
Age: 2.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Chest X-ray, Cough, Pyrexia
Clinical narrative: Dry nighttime cough followed by fever 3 days later. Cough has now become chronic (6+ weeks) with no other symptoms. Multiple examinations have shown nothing. Chest xrays are being done today.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Mobility decreased, Pain
Clinical narrative: Extreme pain. Unable to move arm. Redness at site of injection.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: No date or time onset for adverse reaction used time of vaccine administration date and time.
Age: 1.34
Sex: M
Vaccine: FLU3, HIBV, MMRV
Symptoms: Rash maculo-papular
Clinical narrative: Extensive macular popular rash 1 1/2 days afrer receiving vaccine. Mom says it happened once before, has gotten HIB both times.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain in right upper arm (injection site)
Age: 0.23
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Now has ileo-ileo intussusception. Home today or tomorrow. Dx Abd U/S.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pruritus, Pyrexia, Urticaria, Wheezing
Clinical narrative: Hives and itching, wheezing, fever, sore throat. Took Benadryl OTC. Returned to clinic one week later (12/11/2014) for treatment.  Given Kenalog 40 mg IM and Prednisone dosepak.  Reported on 12/11/14 visit she was allergic to egg. Prior to this visit, she had reported NKA.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Altered state of consciousness, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: Dizziness, nausea, sweating, headache, felt like she was going to consciousness.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Peripheral swelling
Clinical narrative: On 12/8/14 Patient contacted the office to complain that her left deltoid is very sore and red and warm to the touch. On 12/11/14 Patient called again to inform the office that her left arm is swollen and still red.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: No date or time onset for adverse reaction. Under-dose or possible second dose was given. Vaccination error.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Fatigue, Inflammation, Injection site pain
Clinical narrative: Pain at injection site. Inflammation, pain in joints, loss of mobility, muscle wasting, weakness, extreme tiredness.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Muscle atrophy
Clinical narrative: Pain at injection site. Inflammation, pain in joints, loss of mobility, muscle wasting, weakness, extreme tiredness.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Dizziness, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Dizziness, nausea, chilled, sweating, hot; though instructed to notify any nurse at shot clinic for any adverse reactions, patient did not report symptoms until following day; patient had been instructed to remain at clinic for a min of 15 minutes following vaccination since patient had never received a flu shot before.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: No date or time onset for adverse reaction. Under-dose or possible second dose was given. Vaccination error.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination error
Clinical narrative: No date or time onset for adverse reaction. Under-dose or possible second dose was given. Vaccination error.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Local swelling, Soft tissue mass
Clinical narrative: Noticed swelling/ soft tissue mass on left arm developing over the last week. Denies any trauma and only significant event to the affected area was the flu shot administered on 10/27/14.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Dysphagia, Electromyogram, Guillain-Barre syndrome
Clinical narrative: Progressively difficulty swallowing, weakness in left hand and arm, left leg weakness, then right leg weekness. Dr said has Guillain Barre Syndrome. Treatment plasmapherisis x 5.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging, Plasmapheresis
Clinical narrative: Progressively difficulty swallowing, weakness in left hand and arm, left leg weakness, then right leg weekness. Dr said has Guillain Barre Syndrome. Treatment plasmapherisis x 5.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Biopsy site unspecified abnormal, Dizziness, Headache, Myofascitis
Clinical narrative: Vomiting, body ache, dizziness, upper body itching, joint pain that started on the wrists and continued afterwards to every joint. Occasional headaches.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Positron emission tomogram abnormal, Pruritus, Vomiting
Clinical narrative: Vomiting, body ache, dizziness, upper body itching, joint pain that started on the wrists and continued afterwards to every joint. Occasional headaches.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: No date or time onset for adverse reaction. Under-dose or possible second dose was given. Vaccination error.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: PT HAS PAIN IN ARM AND TROUBLE LIFTING HER ARM.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dyspnoea, Lip swelling, Nausea, Pain
Clinical narrative: Body aches, chills, nausea, vomiting, lip swelling, shortness of breath, throat swelling.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal oedema, Vomiting
Clinical narrative: Body aches, chills, nausea, vomiting, lip swelling, shortness of breath, throat swelling.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Ran fever of 101, now site is red, swollen, and feverish.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Head injury, Immediate post-injection reaction, Joint injury, Loss of consciousness, Pain
Clinical narrative: Almost immediately after vaccine she had swelling and pain which is a common side effect.  But later on that day/night she experienced pain and passed out in her hallway and hit her head and elbow and needs to get xrays.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Almost immediately after vaccine she had swelling and pain which is a common side effect.  But later on that day/night she experienced pain and passed out in her hallway and hit her head and elbow and needs to get xrays.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Child developed mild case of chicken pox.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: 12 CM raised area around the injection site, fever, body aches.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Blood test, Hypersensitivity, Immunology test abnormal, Rash generalised, Streptococcus test
Clinical narrative: Left Forearm broke out with full body rash the next morning following a hep B vaccination. 3 days later patient went to urgent care to be evaluated. She was precribed Zantec, Hydroxyzine and Loratadine. The patient took the medications as prescribed. 14Apr14, the patient's condition had worsened and was seen again at an urgent care clinic. They took a blood draw, urine sample, and strep culture. She was given a 80mg steriod shot and presribed methylprednisolone tablets. The following day 15Apr14, the patients rash and swelling got much worse overnight. 16Apr14, the patient was seen by an on base physician and a referral was to a dermatology clinic. She was seen by a dermatology clinic on 17Apr14 and had 2 biopsies done. She was prescribed: Prednisone Taper, Clobetasol, Hydroyzine, Loratadine, Ranitadine. 28 Apr she was informed by the derm clinic that the biopsies were positive for allergic reaction.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Swelling, Type IV hypersensitivity reaction, Urine analysis
Clinical narrative: Left Forearm broke out with full body rash the next morning following a hep B vaccination. 3 days later patient went to urgent care to be evaluated. She was precribed Zantec, Hydroxyzine and Loratadine. The patient took the medications as prescribed. 14Apr14, the patient's condition had worsened and was seen again at an urgent care clinic. They took a blood draw, urine sample, and strep culture. She was given a 80mg steriod shot and presribed methylprednisolone tablets. The following day 15Apr14, the patients rash and swelling got much worse overnight. 16Apr14, the patient was seen by an on base physician and a referral was to a dermatology clinic. She was seen by a dermatology clinic on 17Apr14 and had 2 biopsies done. She was prescribed: Prednisone Taper, Clobetasol, Hydroyzine, Loratadine, Ranitadine. 28 Apr she was informed by the derm clinic that the biopsies were positive for allergic reaction.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site on left arm.