chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: PATIENT EXPERIENCED SWELLING AND WARMTH TO SITE.
Age: 45.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Erythema, Pain, Sensation of heaviness, Skin warm, Swelling
Clinical narrative: RED, SWOLLEN, WARM TO TOUCH, VERY SORE, HEAVY FEELING.
Age: 1.29
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever 100.8 on 6/4/14, fever 102.4 6/5/14, no other symptoms.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Hyperhidrosis, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Severe swelling and extreme pain on upper right arm at place of injection. Dizziness, fever of 101*, sweating, light-headed.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Periorbital oedema, Swelling face
Clinical narrative: Periorbital edema. Seen in ER 24hrs after vaccines with severe periorbital edema and facial swelling. She was given Benadryl. Symptoms resolved within another 24hrs.
Sex: F
Vaccine: FLU3
Symptoms: Erythema multiforme
Clinical narrative: Initial case received on 30 May 2014 from a consumer. A female patient had received on 10 August 2010 an intramuscular left deltoid injection of FLUZONE, lot number U3575FA and an unspecified amount of time later after vaccination, experienced erythema multiforme over her entire body. Treatments and diagnostic testing were not reported. Outcome was unknown. Documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Contusion, Erythema, Nodule, Skin warm, Tenderness
Clinical narrative: Large red welt approx 2 inch long with knot and bruising.  Slightly hot to touch.  Painful to touch.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Large red welt approx 2 inch long with knot and bruising.  Slightly hot to touch.  Painful to touch.
Sex: U
Vaccine: PNC
Symptoms: Purpura fulminans
Clinical narrative: This is a spontaneous report from a contactable physician. A patient of unknown gender and age) received PREVNAR at 1 dosage form single; date and route of administration were unknown. The patient's medical history and concomitant medication were unknown. On an unknown date, the patient experienced severe Purpura fulminans after receiving PREVNAR. The reporting physician stated that although she was not sure she does not think that the event was due to PREVNAR. The clinical outcome of the event, severe Purpura fulminans, was unknown.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Headache, fever to 100F, flu-like body aches, diarrhea.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Joint swelling, Mobility decreased
Clinical narrative: Client states about 36 hours after Tdap was given in her right deltoid her right wrist was swollen and bruised. She also states she had trouble moving her right wrist and hand for 3 days. States no problems at the site of injection. States she did not seek medical care.
Age: 1.51
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site papule, Papule, Scab
Clinical narrative: Initial redness and erythema with 4 discrete erythematous papules at the site of injection. Within 48 h some of those papules had opened and crusted. She developed 10 other discrete papules on chest, buttocks, cheek over next 72h.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Swelling hot red and pain and the next day swelling to the left elbow inflammation and pain.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Swelling hot red and pain and the next day swelling to the left elbow inflammation and pain.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal, Basophil count normal, Bilirubin conjugated normal
Clinical narrative: Client said he received a pneumonia injection yesterday. This morning his left arm is swollen from close to his shoulder down to his elbow. The area is red, painful 8/10, and hot, and his temperature is 101. His mouth is dry, but, not swollen, client said. Client was advised the ER. 1/25/2014 Emergency Dept: cellulitis vs erysipelas, ROCEPHIN 1 gm in ED, TORADOL 60 mg IM for pain, follow up in ED in AM for further evaluation and care. 1/26/2014 Emergency Department: 74 year old male who presents to the Emergency Dept. for F/U cellulitis. Was seen in ER yesterday, received one dose ceftriaxone. Pt feeling much better, able to bend arm, no fever today. Still has pain. No drainage. No significant increase in redness. Cellulitis vs erysipelas. Condition on discharge: Stable. Plan/Instructions: - will treat with KEFLEX and BACTRIM. F/U with PCP in 3-4 days. 1/27/2014 Emergency Dept: pt was seen on 1/25 and given a gram of ROCEPHIN; returned 1/26 and started on KEFLEX and SEPTRA; pt denies any fever since 102 on Saturday, states that he can move the arm better than on Saturday; denies any itching or burning sensation. Admitted as inpatient for left upper arm pain/redness/swelling and fever since he received a pneumonia shot to his left deltoid last Friday. Temperature has been as high as 102 degrees F; patient has not taken any additional medication except for 50 mg of BENADRYL on Friday night. Patient states that area of erythema has been growing, ROM is limited in the affected arm. Current pain level is 5/10 with movement; there is no pain without it. He denies chest pain, dyspnea, difficulty swallowing, and other organic symptoms. Ceftriaxone 1 gm once, ketorolac tromethamine 60 mg once, cephalexin 500 mg QID.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Bilirubin urine, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium decreased
Clinical narrative: Client said he received a pneumonia injection yesterday. This morning his left arm is swollen from close to his shoulder down to his elbow. The area is red, painful 8/10, and hot, and his temperature is 101. His mouth is dry, but, not swollen, client said. Client was advised the ER. 1/25/2014 Emergency Dept: cellulitis vs erysipelas, ROCEPHIN 1 gm in ED, TORADOL 60 mg IM for pain, follow up in ED in AM for further evaluation and care. 1/26/2014 Emergency Department: 74 year old male who presents to the Emergency Dept. for F/U cellulitis. Was seen in ER yesterday, received one dose ceftriaxone. Pt feeling much better, able to bend arm, no fever today. Still has pain. No drainage. No significant increase in redness. Cellulitis vs erysipelas. Condition on discharge: Stable. Plan/Instructions: - will treat with KEFLEX and BACTRIM. F/U with PCP in 3-4 days. 1/27/2014 Emergency Dept: pt was seen on 1/25 and given a gram of ROCEPHIN; returned 1/26 and started on KEFLEX and SEPTRA; pt denies any fever since 102 on Saturday, states that he can move the arm better than on Saturday; denies any itching or burning sensation. Admitted as inpatient for left upper arm pain/redness/swelling and fever since he received a pneumonia shot to his left deltoid last Friday. Temperature has been as high as 102 degrees F; patient has not taken any additional medication except for 50 mg of BENADRYL on Friday night. Patient states that area of erythema has been growing, ROM is limited in the affected arm. Current pain level is 5/10 with movement; there is no pain without it. He denies chest pain, dyspnea, difficulty swallowing, and other organic symptoms. Ceftriaxone 1 gm once, ketorolac tromethamine 60 mg once, cephalexin 500 mg QID.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Blood chloride normal, Blood creatinine increased, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: Client said he received a pneumonia injection yesterday. This morning his left arm is swollen from close to his shoulder down to his elbow. The area is red, painful 8/10, and hot, and his temperature is 101. His mouth is dry, but, not swollen, client said. Client was advised the ER. 1/25/2014 Emergency Dept: cellulitis vs erysipelas, ROCEPHIN 1 gm in ED, TORADOL 60 mg IM for pain, follow up in ED in AM for further evaluation and care. 1/26/2014 Emergency Department: 74 year old male who presents to the Emergency Dept. for F/U cellulitis. Was seen in ER yesterday, received one dose ceftriaxone. Pt feeling much better, able to bend arm, no fever today. Still has pain. No drainage. No significant increase in redness. Cellulitis vs erysipelas. Condition on discharge: Stable. Plan/Instructions: - will treat with KEFLEX and BACTRIM. F/U with PCP in 3-4 days. 1/27/2014 Emergency Dept: pt was seen on 1/25 and given a gram of ROCEPHIN; returned 1/26 and started on KEFLEX and SEPTRA; pt denies any fever since 102 on Saturday, states that he can move the arm better than on Saturday; denies any itching or burning sensation. Admitted as inpatient for left upper arm pain/redness/swelling and fever since he received a pneumonia shot to his left deltoid last Friday. Temperature has been as high as 102 degrees F; patient has not taken any additional medication except for 50 mg of BENADRYL on Friday night. Patient states that area of erythema has been growing, ROM is limited in the affected arm. Current pain level is 5/10 with movement; there is no pain without it. He denies chest pain, dyspnea, difficulty swallowing, and other organic symptoms. Ceftriaxone 1 gm once, ketorolac tromethamine 60 mg once, cephalexin 500 mg QID.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Blood urea increased, Blood urine absent, Body temperature increased, Carbon dioxide normal, Cellulitis
Clinical narrative: Client said he received a pneumonia injection yesterday. This morning his left arm is swollen from close to his shoulder down to his elbow. The area is red, painful 8/10, and hot, and his temperature is 101. His mouth is dry, but, not swollen, client said. Client was advised the ER. 1/25/2014 Emergency Dept: cellulitis vs erysipelas, ROCEPHIN 1 gm in ED, TORADOL 60 mg IM for pain, follow up in ED in AM for further evaluation and care. 1/26/2014 Emergency Department: 74 year old male who presents to the Emergency Dept. for F/U cellulitis. Was seen in ER yesterday, received one dose ceftriaxone. Pt feeling much better, able to bend arm, no fever today. Still has pain. No drainage. No significant increase in redness. Cellulitis vs erysipelas. Condition on discharge: Stable. Plan/Instructions: - will treat with KEFLEX and BACTRIM. F/U with PCP in 3-4 days. 1/27/2014 Emergency Dept: pt was seen on 1/25 and given a gram of ROCEPHIN; returned 1/26 and started on KEFLEX and SEPTRA; pt denies any fever since 102 on Saturday, states that he can move the arm better than on Saturday; denies any itching or burning sensation. Admitted as inpatient for left upper arm pain/redness/swelling and fever since he received a pneumonia shot to his left deltoid last Friday. Temperature has been as high as 102 degrees F; patient has not taken any additional medication except for 50 mg of BENADRYL on Friday night. Patient states that area of erythema has been growing, ROM is limited in the affected arm. Current pain level is 5/10 with movement; there is no pain without it. He denies chest pain, dyspnea, difficulty swallowing, and other organic symptoms. Ceftriaxone 1 gm once, ketorolac tromethamine 60 mg once, cephalexin 500 mg QID.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Chromaturia, Dry mouth, Eosinophil count normal, Eosinophil percentage, Glomerular filtration rate decreased
Clinical narrative: Client said he received a pneumonia injection yesterday. This morning his left arm is swollen from close to his shoulder down to his elbow. The area is red, painful 8/10, and hot, and his temperature is 101. His mouth is dry, but, not swollen, client said. Client was advised the ER. 1/25/2014 Emergency Dept: cellulitis vs erysipelas, ROCEPHIN 1 gm in ED, TORADOL 60 mg IM for pain, follow up in ED in AM for further evaluation and care. 1/26/2014 Emergency Department: 74 year old male who presents to the Emergency Dept. for F/U cellulitis. Was seen in ER yesterday, received one dose ceftriaxone. Pt feeling much better, able to bend arm, no fever today. Still has pain. No drainage. No significant increase in redness. Cellulitis vs erysipelas. Condition on discharge: Stable. Plan/Instructions: - will treat with KEFLEX and BACTRIM. F/U with PCP in 3-4 days. 1/27/2014 Emergency Dept: pt was seen on 1/25 and given a gram of ROCEPHIN; returned 1/26 and started on KEFLEX and SEPTRA; pt denies any fever since 102 on Saturday, states that he can move the arm better than on Saturday; denies any itching or burning sensation. Admitted as inpatient for left upper arm pain/redness/swelling and fever since he received a pneumonia shot to his left deltoid last Friday. Temperature has been as high as 102 degrees F; patient has not taken any additional medication except for 50 mg of BENADRYL on Friday night. Patient states that area of erythema has been growing, ROM is limited in the affected arm. Current pain level is 5/10 with movement; there is no pain without it. He denies chest pain, dyspnea, difficulty swallowing, and other organic symptoms. Ceftriaxone 1 gm once, ketorolac tromethamine 60 mg once, cephalexin 500 mg QID.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Glucose urine absent, Granulocyte count, Granulocyte percentage, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Client said he received a pneumonia injection yesterday. This morning his left arm is swollen from close to his shoulder down to his elbow. The area is red, painful 8/10, and hot, and his temperature is 101. His mouth is dry, but, not swollen, client said. Client was advised the ER. 1/25/2014 Emergency Dept: cellulitis vs erysipelas, ROCEPHIN 1 gm in ED, TORADOL 60 mg IM for pain, follow up in ED in AM for further evaluation and care. 1/26/2014 Emergency Department: 74 year old male who presents to the Emergency Dept. for F/U cellulitis. Was seen in ER yesterday, received one dose ceftriaxone. Pt feeling much better, able to bend arm, no fever today. Still has pain. No drainage. No significant increase in redness. Cellulitis vs erysipelas. Condition on discharge: Stable. Plan/Instructions: - will treat with KEFLEX and BACTRIM. F/U with PCP in 3-4 days. 1/27/2014 Emergency Dept: pt was seen on 1/25 and given a gram of ROCEPHIN; returned 1/26 and started on KEFLEX and SEPTRA; pt denies any fever since 102 on Saturday, states that he can move the arm better than on Saturday; denies any itching or burning sensation. Admitted as inpatient for left upper arm pain/redness/swelling and fever since he received a pneumonia shot to his left deltoid last Friday. Temperature has been as high as 102 degrees F; patient has not taken any additional medication except for 50 mg of BENADRYL on Friday night. Patient states that area of erythema has been growing, ROM is limited in the affected arm. Current pain level is 5/10 with movement; there is no pain without it. He denies chest pain, dyspnea, difficulty swallowing, and other organic symptoms. Ceftriaxone 1 gm once, ketorolac tromethamine 60 mg once, cephalexin 500 mg QID.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth, Local swelling
Clinical narrative: Client said he received a pneumonia injection yesterday. This morning his left arm is swollen from close to his shoulder down to his elbow. The area is red, painful 8/10, and hot, and his temperature is 101. His mouth is dry, but, not swollen, client said. Client was advised the ER. 1/25/2014 Emergency Dept: cellulitis vs erysipelas, ROCEPHIN 1 gm in ED, TORADOL 60 mg IM for pain, follow up in ED in AM for further evaluation and care. 1/26/2014 Emergency Department: 74 year old male who presents to the Emergency Dept. for F/U cellulitis. Was seen in ER yesterday, received one dose ceftriaxone. Pt feeling much better, able to bend arm, no fever today. Still has pain. No drainage. No significant increase in redness. Cellulitis vs erysipelas. Condition on discharge: Stable. Plan/Instructions: - will treat with KEFLEX and BACTRIM. F/U with PCP in 3-4 days. 1/27/2014 Emergency Dept: pt was seen on 1/25 and given a gram of ROCEPHIN; returned 1/26 and started on KEFLEX and SEPTRA; pt denies any fever since 102 on Saturday, states that he can move the arm better than on Saturday; denies any itching or burning sensation. Admitted as inpatient for left upper arm pain/redness/swelling and fever since he received a pneumonia shot to his left deltoid last Friday. Temperature has been as high as 102 degrees F; patient has not taken any additional medication except for 50 mg of BENADRYL on Friday night. Patient states that area of erythema has been growing, ROM is limited in the affected arm. Current pain level is 5/10 with movement; there is no pain without it. He denies chest pain, dyspnea, difficulty swallowing, and other organic symptoms. Ceftriaxone 1 gm once, ketorolac tromethamine 60 mg once, cephalexin 500 mg QID.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Lymphocyte count normal, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal
Clinical narrative: Client said he received a pneumonia injection yesterday. This morning his left arm is swollen from close to his shoulder down to his elbow. The area is red, painful 8/10, and hot, and his temperature is 101. His mouth is dry, but, not swollen, client said. Client was advised the ER. 1/25/2014 Emergency Dept: cellulitis vs erysipelas, ROCEPHIN 1 gm in ED, TORADOL 60 mg IM for pain, follow up in ED in AM for further evaluation and care. 1/26/2014 Emergency Department: 74 year old male who presents to the Emergency Dept. for F/U cellulitis. Was seen in ER yesterday, received one dose ceftriaxone. Pt feeling much better, able to bend arm, no fever today. Still has pain. No drainage. No significant increase in redness. Cellulitis vs erysipelas. Condition on discharge: Stable. Plan/Instructions: - will treat with KEFLEX and BACTRIM. F/U with PCP in 3-4 days. 1/27/2014 Emergency Dept: pt was seen on 1/25 and given a gram of ROCEPHIN; returned 1/26 and started on KEFLEX and SEPTRA; pt denies any fever since 102 on Saturday, states that he can move the arm better than on Saturday; denies any itching or burning sensation. Admitted as inpatient for left upper arm pain/redness/swelling and fever since he received a pneumonia shot to his left deltoid last Friday. Temperature has been as high as 102 degrees F; patient has not taken any additional medication except for 50 mg of BENADRYL on Friday night. Patient states that area of erythema has been growing, ROM is limited in the affected arm. Current pain level is 5/10 with movement; there is no pain without it. He denies chest pain, dyspnea, difficulty swallowing, and other organic symptoms. Ceftriaxone 1 gm once, ketorolac tromethamine 60 mg once, cephalexin 500 mg QID.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Mean platelet volume normal, Monocyte percentage increased, Nitrite urine absent, Pain, Platelet count normal
Clinical narrative: Client said he received a pneumonia injection yesterday. This morning his left arm is swollen from close to his shoulder down to his elbow. The area is red, painful 8/10, and hot, and his temperature is 101. His mouth is dry, but, not swollen, client said. Client was advised the ER. 1/25/2014 Emergency Dept: cellulitis vs erysipelas, ROCEPHIN 1 gm in ED, TORADOL 60 mg IM for pain, follow up in ED in AM for further evaluation and care. 1/26/2014 Emergency Department: 74 year old male who presents to the Emergency Dept. for F/U cellulitis. Was seen in ER yesterday, received one dose ceftriaxone. Pt feeling much better, able to bend arm, no fever today. Still has pain. No drainage. No significant increase in redness. Cellulitis vs erysipelas. Condition on discharge: Stable. Plan/Instructions: - will treat with KEFLEX and BACTRIM. F/U with PCP in 3-4 days. 1/27/2014 Emergency Dept: pt was seen on 1/25 and given a gram of ROCEPHIN; returned 1/26 and started on KEFLEX and SEPTRA; pt denies any fever since 102 on Saturday, states that he can move the arm better than on Saturday; denies any itching or burning sensation. Admitted as inpatient for left upper arm pain/redness/swelling and fever since he received a pneumonia shot to his left deltoid last Friday. Temperature has been as high as 102 degrees F; patient has not taken any additional medication except for 50 mg of BENADRYL on Friday night. Patient states that area of erythema has been growing, ROM is limited in the affected arm. Current pain level is 5/10 with movement; there is no pain without it. He denies chest pain, dyspnea, difficulty swallowing, and other organic symptoms. Ceftriaxone 1 gm once, ketorolac tromethamine 60 mg once, cephalexin 500 mg QID.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Protein total normal, Protein urine absent, Pyrexia, Red blood cell count decreased, Red cell distribution width normal
Clinical narrative: Client said he received a pneumonia injection yesterday. This morning his left arm is swollen from close to his shoulder down to his elbow. The area is red, painful 8/10, and hot, and his temperature is 101. His mouth is dry, but, not swollen, client said. Client was advised the ER. 1/25/2014 Emergency Dept: cellulitis vs erysipelas, ROCEPHIN 1 gm in ED, TORADOL 60 mg IM for pain, follow up in ED in AM for further evaluation and care. 1/26/2014 Emergency Department: 74 year old male who presents to the Emergency Dept. for F/U cellulitis. Was seen in ER yesterday, received one dose ceftriaxone. Pt feeling much better, able to bend arm, no fever today. Still has pain. No drainage. No significant increase in redness. Cellulitis vs erysipelas. Condition on discharge: Stable. Plan/Instructions: - will treat with KEFLEX and BACTRIM. F/U with PCP in 3-4 days. 1/27/2014 Emergency Dept: pt was seen on 1/25 and given a gram of ROCEPHIN; returned 1/26 and started on KEFLEX and SEPTRA; pt denies any fever since 102 on Saturday, states that he can move the arm better than on Saturday; denies any itching or burning sensation. Admitted as inpatient for left upper arm pain/redness/swelling and fever since he received a pneumonia shot to his left deltoid last Friday. Temperature has been as high as 102 degrees F; patient has not taken any additional medication except for 50 mg of BENADRYL on Friday night. Patient states that area of erythema has been growing, ROM is limited in the affected arm. Current pain level is 5/10 with movement; there is no pain without it. He denies chest pain, dyspnea, difficulty swallowing, and other organic symptoms. Ceftriaxone 1 gm once, ketorolac tromethamine 60 mg once, cephalexin 500 mg QID.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Specific gravity urine normal, Urine analysis normal, Urine ketone body absent, Urine leukocyte esterase, Urobilinogen urine increased
Clinical narrative: Client said he received a pneumonia injection yesterday. This morning his left arm is swollen from close to his shoulder down to his elbow. The area is red, painful 8/10, and hot, and his temperature is 101. His mouth is dry, but, not swollen, client said. Client was advised the ER. 1/25/2014 Emergency Dept: cellulitis vs erysipelas, ROCEPHIN 1 gm in ED, TORADOL 60 mg IM for pain, follow up in ED in AM for further evaluation and care. 1/26/2014 Emergency Department: 74 year old male who presents to the Emergency Dept. for F/U cellulitis. Was seen in ER yesterday, received one dose ceftriaxone. Pt feeling much better, able to bend arm, no fever today. Still has pain. No drainage. No significant increase in redness. Cellulitis vs erysipelas. Condition on discharge: Stable. Plan/Instructions: - will treat with KEFLEX and BACTRIM. F/U with PCP in 3-4 days. 1/27/2014 Emergency Dept: pt was seen on 1/25 and given a gram of ROCEPHIN; returned 1/26 and started on KEFLEX and SEPTRA; pt denies any fever since 102 on Saturday, states that he can move the arm better than on Saturday; denies any itching or burning sensation. Admitted as inpatient for left upper arm pain/redness/swelling and fever since he received a pneumonia shot to his left deltoid last Friday. Temperature has been as high as 102 degrees F; patient has not taken any additional medication except for 50 mg of BENADRYL on Friday night. Patient states that area of erythema has been growing, ROM is limited in the affected arm. Current pain level is 5/10 with movement; there is no pain without it. He denies chest pain, dyspnea, difficulty swallowing, and other organic symptoms. Ceftriaxone 1 gm once, ketorolac tromethamine 60 mg once, cephalexin 500 mg QID.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count normal, pH urine normal
Clinical narrative: Client said he received a pneumonia injection yesterday. This morning his left arm is swollen from close to his shoulder down to his elbow. The area is red, painful 8/10, and hot, and his temperature is 101. His mouth is dry, but, not swollen, client said. Client was advised the ER. 1/25/2014 Emergency Dept: cellulitis vs erysipelas, ROCEPHIN 1 gm in ED, TORADOL 60 mg IM for pain, follow up in ED in AM for further evaluation and care. 1/26/2014 Emergency Department: 74 year old male who presents to the Emergency Dept. for F/U cellulitis. Was seen in ER yesterday, received one dose ceftriaxone. Pt feeling much better, able to bend arm, no fever today. Still has pain. No drainage. No significant increase in redness. Cellulitis vs erysipelas. Condition on discharge: Stable. Plan/Instructions: - will treat with KEFLEX and BACTRIM. F/U with PCP in 3-4 days. 1/27/2014 Emergency Dept: pt was seen on 1/25 and given a gram of ROCEPHIN; returned 1/26 and started on KEFLEX and SEPTRA; pt denies any fever since 102 on Saturday, states that he can move the arm better than on Saturday; denies any itching or burning sensation. Admitted as inpatient for left upper arm pain/redness/swelling and fever since he received a pneumonia shot to his left deltoid last Friday. Temperature has been as high as 102 degrees F; patient has not taken any additional medication except for 50 mg of BENADRYL on Friday night. Patient states that area of erythema has been growing, ROM is limited in the affected arm. Current pain level is 5/10 with movement; there is no pain without it. He denies chest pain, dyspnea, difficulty swallowing, and other organic symptoms. Ceftriaxone 1 gm once, ketorolac tromethamine 60 mg once, cephalexin 500 mg QID.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Paraesthesia, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to approximately 66 year old female patient. The patients medical history included prior case of shingles. There was no drug reactions/ allergies included. On 08-MAY-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, one dose, subcutaneous (anatomical location, lot# not reported). No concomitant medications reported. The pharmacist reported that today (date of report that is 22-MAY-2014) came into the pharmacy with a rash on her forehead, experienced approximately on 20-MAY-2014 (calculated based on date adverse event first reported from that subtracted 2 days, because it was also reported as couple of days ago by the reporter). The patient also stated that the rash was also tingling, and therefore patient believed that it may be the shingles. The patient sought medical attention (contacted pharmacist). There was no treatment for the adverse event given. The outcome of rash was also tingling and rash on her forehead was reported as not recovered/not resolved. The outcome of patient believed that it may be the shingles was unknown. The patient was not hospitalized due to experience. The experience was not life threatening. There was no persistent or significant incapacity. No death. Intervention to prevent serious criteria was not required. Product quality complaint was not involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site rash, Paraesthesia, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to approximately 66 year old female patient. The patients medical history included prior case of shingles. There was no drug reactions/ allergies included. On 08-MAY-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, one dose, subcutaneous (anatomical location, lot# not reported). No concomitant medications reported. The pharmacist reported that today (date of report that is 22-MAY-2014) came into the pharmacy with a rash on her forehead, experienced approximately on 20-MAY-2014 (calculated based on date adverse event first reported from that subtracted 2 days, because it was also reported as couple of days ago by the reporter). The patient also stated that the rash was also tingling, and therefore patient believed that it may be the shingles. The patient sought medical attention (contacted pharmacist). There was no treatment for the adverse event given. The outcome of rash was also tingling and rash on her forehead was reported as not recovered/not resolved. The outcome of patient believed that it may be the shingles was unknown. The patient was not hospitalized due to experience. The experience was not life threatening. There was no persistent or significant incapacity. No death. Intervention to prevent serious criteria was not required. Product quality complaint was not involved. Additional information has been requested.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an 89 year old male patient. The patient's pertinent medical history and drug reactions/allergies were not reported. On 21-MAY-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml (route and lot # not reported). The patient was then prescribed a 5 days course of prednisone (manufacturer unknown) beginning with a 50 mg dose on 30-MAY-2014 for an unspecified reason. The patient had not begun prednisone (manufacturer unknown) yet. The outcome of the event was unknown. The relationship between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from other health professional refers to a patient of unknown age and gender. Medical history was not reported. On 28-APR-2014 the patient was vaccinated with PROQUAD (Merck) (subcutaneous, dose number, frequency, anatomical locations, lot number was not reported). Concomitant medications were not reported. The reporter stated that the patient was administered PROQUAD which was out of range for 108 hours reaching -14 degree Celsius. The vaccines were supported. No adverse effects reported. This report is linked another MARRS # 1405USA011156 (Same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from other health professional refers to a patient of unknown age and gender. Medical history was not reported. On 23-APR-2014 the patient was vaccinated with PROQUAD (subcutaneous, dose number, frequency, anatomical locations, lot number was not reported). Concomitant medications were not reported. The reporter stated that the patient was administered PROQUAD which was out of range for 108 hours reaching -14 degree Celsius. The vaccines were supported. No adverse effects reported. This report is linked with another MARRS # 1405USA011991 (same reporter link). Additional information has been requested.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 76 year old patient of unknown gender. On 21-May-2014 the patient was vaccinated by the pharmacist with ZOSTAVAX (lot # J001698, expiry date: 08-MAY-2014, 0.65 ml once, subcutaneously). No adverse events were reported. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Therapeutic response unexpected
Clinical narrative: This spontaneous report as received from a 56 year old male patient with recurrent respiratory papilloma (RRPP) refers to himself. The patient had no pertinent medical history and drug reactions or allergies. About a year ago, in June 2013, the patient was vaccinated with GARDASIL (dose, number, dose, frequency, route and lot number not reported). The patient completed the 3 dose series of doctor's office, actual dates unspecified. There were no concomitant medications. The patient ws outside age indication for GARDASIL as he had a condition called recurrent respiratory papilloma (RRPP). The patient stated: "RRPP is the same virus, HPV, but affects vocal cords, requires periodic surgeries." The patient discussed taking GARDASIL with physicians in order to prevent reoccurrence and minimize need for surgery. The patient stated that ever since he took GARDASIL, condition had not flared up. The patient had seen specialist doctor twice, the doctor checked patient's condition periodically with certain instruments to take pictures of vocal cords and there was not much growth. The patient stated he was doing fine now and would see the doctor again over the summer for follow up evaluation. Additional information has been requested,
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Maternal exposure before pregnancy, Viral titre decreased
Clinical narrative: This spontaneous retrospective pregnancy report as received from a female pharmacist refers to herself as a patient. The patient had no concomitant medication, pertinent medical history and drug allergies/reactions. The patient was vaccinated with two doses of VARIVAX (Merck) (dose, route and lot# were not provided) on unspecified dates in the year of 2011. The patient reported that her gynecologist drew titers on an unspecified date in 2011 and the results showed a low titer. She also reported that at the time the titers were drawn in 2011 she was pregnant. The last menstrual period (LMP) and expected date of delivery (EDD) were unknown. The pregnancy outcome was unknown, but she stated that she was not pregnant at the time of the report. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer (reported as patient's husband) refers to a 60 year old female patient with no pertinent medical history and drug reactions or allergies. On 08-MAY-2014 the patient was vaccinated with ZOSTAVAX, vial (lot# and expiration date not provided) (dose not reported), route reported as "injection". Concomitant therapies included unspecified vitamins (manufacturer unknown). On 12-MAY-2014, the patient noticed an unspecified amount of red circles on her skin on her right inner thigh. The circles had a darker red core. There were 4 additional red spots in the same area. They were searched what that could be and had diagnosed it as shingles. The red circles did not itch or hurt. No diagnostic tests were reported. The patient did not seek medical attention. The outcome of the event of shingles was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site. Treated with Keflex.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Pt c/o dizziness after receiving Hep B vaccine.  Pt put down on floor w/ supervisor assistance.  At 1445, bp: 123/73, HR: 50.  MD and supervisor was notified.  At 1450, BP: 119/67, HR: 56.  Pt denied any discomfort at this time, was able to eat and drink.  Pt left ward w/o assistance at 1505.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: AT SITE OF INJECTION:  3 INCH X 3 INCH RED, SWOLLEN, ITCHY AT SITE.
Age: 0.85
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Electroencephalogram, Full blood count normal, Grand mal convulsion, Metabolic function test normal, Muscle contracture
Clinical narrative: Infant developed high fever approximately 3 hours after vaccine given. Fever got up to 105 and infant was brought to ER. Infant had generalized tonic clonic seizure while at ER. 1st seizure lasted about 1 minute and a dose of Valium was given. Continued contracture of hands and feet, so 2nd dose of Valium given. Total episode lasted approximately 15 minutes. Has been hospitalized x 24 hours thus far. Temp down to 100.7 as of approximately 3:00 PM on 6-5-14.
Age: 0.85
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Infant developed high fever approximately 3 hours after vaccine given. Fever got up to 105 and infant was brought to ER. Infant had generalized tonic clonic seizure while at ER. 1st seizure lasted about 1 minute and a dose of Valium was given. Continued contracture of hands and feet, so 2nd dose of Valium given. Total episode lasted approximately 15 minutes. Has been hospitalized x 24 hours thus far. Temp down to 100.7 as of approximately 3:00 PM on 6-5-14.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: Pt woke up at night with extreme itching on both legs and arms. Pt took Benadryl with some relief.  Sxs came back next morning.
Age: 60.0
Sex: F
Vaccine: YF, YF
Symptoms: Clumsiness, Confusional state, Gait disturbance, Headache, Muscular weakness
Clinical narrative: Acute onset of L leg weakness and difficulty walking. Following day had onset of acute febrile episode with myalgia, headache.  Started on prednisone with improvement in muscle function.  Weaning off steroids had onset of headache, confusion, hand tremor and clumsiness, decreased visual acuity.
Age: 60.0
Sex: F
Vaccine: YF, YF
Symptoms: Myalgia, Pyrexia, Tremor, Visual acuity reduced
Clinical narrative: Acute onset of L leg weakness and difficulty walking. Following day had onset of acute febrile episode with myalgia, headache.  Started on prednisone with improvement in muscle function.  Weaning off steroids had onset of headache, confusion, hand tremor and clumsiness, decreased visual acuity.
Age: 60.0
Sex: F
Vaccine: YF, YF
Symptoms: Arthralgia, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: Acute onset of L leg weakness and difficulty walking. Following day had onset of acute febrile episode with myalgia, headache.  Started on prednisone with improvement in muscle function.  Weaning off steroids had onset of headache, confusion, hand tremor and clumsiness, decreased visual acuity.
Age: 60.0
Sex: F
Vaccine: YF, YF
Symptoms: Clumsiness, Confusional state, Gait disturbance, Headache, Muscular weakness
Clinical narrative: Client states: c/o left leg weakness. Dx: Lumbosacral plexitis. C/O slight febrile; muscle and joint pain. Hx of chronic immunosuppressive condition, off Rx 3 months before YF given. Neurologist suggests these symptoms began after YF administered.
Age: 60.0
Sex: F
Vaccine: YF, YF
Symptoms: Myalgia, Pyrexia, Tremor, Visual acuity reduced
Clinical narrative: Client states: c/o left leg weakness. Dx: Lumbosacral plexitis. C/O slight febrile; muscle and joint pain. Hx of chronic immunosuppressive condition, off Rx 3 months before YF given. Neurologist suggests these symptoms began after YF administered.
Age: 60.0
Sex: F
Vaccine: YF, YF
Symptoms: Arthralgia, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: Client states: c/o left leg weakness. Dx: Lumbosacral plexitis. C/O slight febrile; muscle and joint pain. Hx of chronic immunosuppressive condition, off Rx 3 months before YF given. Neurologist suggests these symptoms began after YF administered.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Swelling, Tenderness
Clinical narrative: Noticed a bump above L clavicle that was tender; when checking injection site on L deltoid, noticed it was red and slightly tender.
Age: 0.52
Sex: M
Vaccine: HEP
Symptoms: Convulsion
Clinical narrative: Seizure.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Chills, Dizziness, Malaise, Nausea
Clinical narrative: Body aches, malaise, mild fever, vertigo, light headedness, abdominal pain, 6/10 pain at vaccination site, tachycardia, chills, nausea.  All symptoms still ongoing at time of report.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Tachycardia, Vaccination site pain, Vertigo
Clinical narrative: Body aches, malaise, mild fever, vertigo, light headedness, abdominal pain, 6/10 pain at vaccination site, tachycardia, chills, nausea.  All symptoms still ongoing at time of report.
Age: 29.0
Sex: F
Vaccine: TYP
Symptoms: Dyspnoea, Headache, Urticaria
Clinical narrative: Hives, Difficulty breathing, headache.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site mass, Muscular weakness, Nerve conduction studies, Pain in extremity
Clinical narrative: Patient experienced weakness in the right hand, with pain, tension from the shoulder all the way down the arm, in a line through the elbow to the hand. Patient also had a localized lump at the injection site. He had some difficulty flexing his right upper extremity and has some shakiness in it when he did so.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Tension, Tremor
Clinical narrative: Patient experienced weakness in the right hand, with pain, tension from the shoulder all the way down the arm, in a line through the elbow to the hand. Patient also had a localized lump at the injection site. He had some difficulty flexing his right upper extremity and has some shakiness in it when he did so.
Age: 17.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Induration, Local swelling
Clinical narrative: Local redness and swelling to about 5cm of firm induration. No discharge. No evidence of abscess.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Convulsion, Laboratory test, Pyrexia
Clinical narrative: Fever, seizure.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a patient of unknown age. On 27-MAY-2014 the patient received expired M-M-R II (lot number H009781; expired date 15-MAY-2014) (dose, route and indication were not reported). The healthcare worker did not specify which dose number this was in the M-M-R II series. No adverse symptoms reported. The healthcare worker stated that M-M-R II in question has not had any previous temperature excursions. The outcome and action taken were not provided. It was not specified if the patient sought any medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse who reported that an unspecified patient on an unspecified date was vaccinated with ZOSTAVAX (lot#J014812, expiry date: 20-FEB-2015; dose and route not reported) that was stored at -5C for six hours (temperature outside of the prescribing information). No adverse events were reported. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash macular
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 66 year old male patient with no drug reactions/allergies. Within the last 42 days on approximately 15-APR-2014 the patient was vaccinated with a dose of ZOSTAVAX. The patient presented to the E.R. department on 27-MAY-2014 with a "macular rash which appears to be shingles, present on all four extremities and trunk". Pharmacist stated that "the patient will not be admitted to the hospital and will be released soon". No treatment given for the AE. The outcome of the adverse event was reported as not recovered/not resolved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old patient of unknown gender. Medical history was not reported. On 27-MAY-2014 the patient was vaccinated with M-M-R II (0.5 ml, subcutaneously, dose number, anatomical location, lot number was not reported). Other suspect therapies included PROQUAD. Concomitant medications were not reported. On 27-MAY-2014 the patient was inadvertently administered a 0.5 ml dose of experienced inadvertently administered a 0.5 ml dose of PROQUAD and a 0.5 ml dose of M-M-R II. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 23-MAY-2014 the patient was vaccinated with PNEUMOVAX23, 0.5 ml, intramuscular, lot # h018944, expiration date 01-MAR-2014; location of administration was not reported. The patient received expired dose of PNEUMOVAX23 on 23-MAY-2014. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect dose administered, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 27-MAY-2014, the patient was vaccinated with the third dose of VARIVAX, intramuscularly, 0.5 ml (lot # and expiration date were not provided). Nurse stated that on 27-MAY-2014, she had administered the third dose of VARIVAX via the intramuscular route. No adverse effect was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker via company representative refers to a 69 year old male patient. In 2008, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose, lot number and expiry date not reported) and then received ZOSTAVAX subcutaneous (dose, lot number and expiry date not reported) on 30-MAY-2014. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a female patient of unknown age. On 14-SEP-2012, the patient was vaccinated with first dose of GARDASIL (0.5 ml) intramuscular. The nurse reported that on 03-JUN-2013, the patient was currently in the office to receive her second dose of GARDASIL. No adverse effect reported. No further information was provided. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix abnormal, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 22 years old female patient without any pertinent medical history, drug reactions or allergies. On an unknown date, the patient was vaccinated with GARDASIL (dose, strength and route were not reported). Secondary therapies were not reported. There was no concomitant medication. Medical assistant reported that patient that received GARDASIL on an unspecified date had a pap smear in March 2014 and the result of her pap smear was "abnormal" and positive to HPV. Medical assistant stated that the patient had a biopsy done on 03-APR-2014 and the result showed the patient was "high risk HPV". No treatment was given for the adverse event. It was reported that the patient sought medical attention by seeing the physician. Medical assistant reports that the patient will be having a repeat pap smear in "three months from March 2014". Additional information has been requested.