chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: RV1
Symptoms: Rotavirus infection, Vaccination failure
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of rotavirus infection in a 32-month-old female subject who was vaccinated with live ROTARIX (GlaxoSmithKline). On 27 August 2010 and 27 October 2010 the subject received 1st dose and 2nd dose of ROTARIX (oral). Years after vaccination with ROTARIX, the subject experienced rotavirus infection and vaccination failure. The physician reported a "confirmed case of Rotavirus in a patient that received vaccination with ROTARIX." No further details were available at the time of reporting. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 years old patient (of an unknown gender) who on 15-OCT-2012 was vaccinated with ZOSTAVAX injection vial, 1 standard dose subcutaneous for shingles prevention. In October 2012 3-5 days later the patient experienced mild rash approximately 5-6 inches surrounding the ZOSTAVAX injection site. It was not specified if the patient sought medical attention. The outcome of mild rash approximately 5-6 inches surrounding at the injection site was reported as recovered on an unspecified date. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash pruritic
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a currently 60 years old female patient. On 27-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). The pharmacist reported that on an unknown date, "shortly thereafter vaccination", the patient broke out with itchy rash on her torso. The patient ignored the itchy rash as there were no other symptoms. The patient did not consult a physician for the itchy rash. The patient had her routine medical exam in February 2013. At this time her physician diagnosed her with a mild case of shingles and stated he did not think it was related to the vaccine. The outcome of mild case of shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from personnel from the Immunization Program referring to 2 patients of unknown gender and age. On an unknown date these patients were vaccinated with PNEUMOVAX23 (lot number and expiration date not specified) (dose and route not reported). On an unknown date the patients were diagnosed with cellulitis after the administration of PNEUMOVAX23. The outcome for cellulitis was unknown at the time of the report. No treatment information was reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age (no demographic details were provided). The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX. No further dosing information was provided. It was unknown if the patient took any concomitant medications and no other suspect medications were reported. On an unknown date, 5 days after administration of ZOSTAVAX, the patient presented with shingles. The outcome of shingles is unknown. The action taken with ZOSTAVAX was not applicable. The reporter provided no assessment for the causality between ZOSTAVAX and the shingles. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from an unknown source via company representative referred to a 53 year old male patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose not reported) (Batch# H019037, expiration date unknown). Concomitant medication, medical history and drug reaction/allergies were not reported. On an unknown date the patient developed a 22 cm x 19 cm whelp. The outcome of the event was unknown. The patient sought for medical attention, spoke with the original HCP. It was unknown if the patient received treatment. This is one of two reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4, MMR, PPV, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse who refers to an unknown number of patients (gender and age were unspecified). The reporter mentioned that an unknown number of patients might have received M-M-R II (lot # and exp date were unspecified) (Dose, route and frequency unspecified), GARDASIL (lot # and exp date were unspecified) (Dose, route and frequency unspecified), live, oral, ROTATEQ (lot # and exp date were unspecified) (Dose, route and frequency unspecified), PNEUMOVAX23 (lot # and exp date were unspecified) (Dose, route and frequency unspecified) or RECOMBIVAX HB (lot # and exp date were unspecified) (Dose, route and frequency unspecified); that was stored on 07-FEB-2013 at 9 degrees C for 24 hours and then on 08-FEB-2013 exposed to 9 degrees C for 72 hours and there was no stability data to support. The nurse is part of The Vaccine Program (VFC) at the health department and stated this happened at the two physicians office. No adverse effect reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from an unspecified reporter via company representative company representative referred to a 60 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose not reported) (Batch# H019037, expiration date unknown). Concomitant medication, medical history and drug reaction/allergies were not reported. On an unknown date the patient developed a 7cm x 10 cm whelp. The outcome of the event was unknown. The patient sought for medical attention, spoke with the original HCP. It was unknown if the patient received treatment. This is one of two reports received from the same source. Additional information is not expected.
Age: 67.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash pustular
Clinical narrative: Pharmacist administered ZOSTAVAX to this patient on 2/27/13. Patient came back to the pharmacy (4-5 days later) with a rash on his other arm.
Age: 67.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Pharmacist administered ZOSTAVAX to this patient on 2/27/13. Patient came back to the pharmacy (4-5 days later) with a rash on his other arm.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Severe muscle ache in right deltoid.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Patient has soreness around the injection site and the whole backside of the arm is red and swollen with patchy spots randomly placed throughout arm. The patient was told to take Benadryl and apply hydrocortisone cream to the area. This has been occurring for 2 days now and patient knows to call MD if size of area or condition worsens.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Laser therapy, Scar, Skin cosmetic procedure
Clinical narrative: Shingles on her left side of forehead and left side of face.
Age: 0.51
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Blood test, Cyanosis, Dyspnoea, Electrocardiogram, Electroencephalogram
Clinical narrative: My 6 month old son appeared to be struggling to breathe, his face turned red and pale, and his lips turned blue/purple.  This lasted for about 15 seconds and then he became really sleepy and fell asleep, this occurred a total of 7 times that day, we took him to the ER and were air lifted to a different hospital.
Age: 0.51
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Erythema, Pallor, Somnolence, Urine analysis, X-ray
Clinical narrative: My 6 month old son appeared to be struggling to breathe, his face turned red and pale, and his lips turned blue/purple.  This lasted for about 15 seconds and then he became really sleepy and fell asleep, this occurred a total of 7 times that day, we took him to the ER and were air lifted to a different hospital.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP
Symptoms: Rash erythematous
Clinical narrative: Parent reported rash after 4 mo set of vaccines; therefore only DTaP & Hep B were administered at 6 mo (since Hep B not given at 4 mo). Within 5 minutes of vaccine administration IM, pt began developing a red rash to neck and face but appeared different than rash at 4 months. Pt was given BENDARYL in office and told to give Q 6 hours until clear. Pt was seen 2 more times over the next 5 days.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: Doctor diagnosed acute disseminated encephalitis of left leg.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Blood test, Cough, Decreased appetite
Clinical narrative: 1-15-13 Body aches, hot/cold body temp., no appetite, complained of tiredness and weakness, lightheaded, dry cough, could not do daily self-care, personal hygiene got worse 1/23/13, nausea, vomit, fever. 2/25/13 Severe cough, diarrhea, dizziness - physical weakness.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Electrocardiogram, Fatigue, Feeling of body temperature change
Clinical narrative: 1-15-13 Body aches, hot/cold body temp., no appetite, complained of tiredness and weakness, lightheaded, dry cough, could not do daily self-care, personal hygiene got worse 1/23/13, nausea, vomit, fever. 2/25/13 Severe cough, diarrhea, dizziness - physical weakness.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Pyrexia, Urine analysis, Vomiting
Clinical narrative: 1-15-13 Body aches, hot/cold body temp., no appetite, complained of tiredness and weakness, lightheaded, dry cough, could not do daily self-care, personal hygiene got worse 1/23/13, nausea, vomit, fever. 2/25/13 Severe cough, diarrhea, dizziness - physical weakness.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Pemphigoid
Clinical narrative: This spontaneous report as received from a consumer refers to an approximately 82 (currently 84 year old) mother with being breast cancer with no known allergies and a medical history of cardiac stenting. On 25-AUG-2010 the patient was vaccinated with a dose of ZOSTAVAX. Route, lot number and expiration date not reported. Concomitant medication were not reported. Shortly after vaccination, on an unknown date, the patient was diagnosed with bullous pemphigoid. The consumer reported that on an unspecified date an unspecified dermatologist started the patient on unspecified doses of corticosteroids (manufacturer unknown) which led to the patient becaming very weak and almost falling down (MARRS 1303USA007082). The consumer reported that the weakness improved when the corticosteroids dosage was reduced, but that the corticosteroid therapy had not really improved the bullous pemphigoid (MARRS 1303USA007082). The outcome of bullous pemphigoid was reported as not recovered/not resolved. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: MU, RUB
Symptoms: Injection site pain, Injection site swelling, Rash generalised
Clinical narrative: Pain and swelling at the place where the vaccine is injected; mild rash over body, neck, and face.
Age: 20.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Injection site rash, Myalgia
Clinical narrative: I developed a rash on my left upper arm, around the injection site, that subsequently formed across part of my back and all of the front of my neck. It still remains today, 3/17/2013. I also had some muscle aches associated with the injection, but nothing to really complain about.
Age: 30.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood culture negative, Culture wound positive, Gangrene, Injection site erythema, Injection site oedema
Clinical narrative: Fever; increased white blood cell count; erythema, warmth, tenderness, edema at injection site.
Age: 30.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site warmth, Muscle necrosis, Myositis, Pathology test
Clinical narrative: Fever; increased white blood cell count; erythema, warmth, tenderness, edema at injection site.
Age: 30.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Staphylococcal infection, White blood cell count increased
Clinical narrative: Fever; increased white blood cell count; erythema, warmth, tenderness, edema at injection site.
Age: 1.03
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Red Bumps - Rash, Fever.
Age: 1.94
Sex: M
Vaccine: HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Cough, Food allergy, Pyrexia, Rash generalised
Clinical narrative: Patient developed increasingly worse skin rashes over his entire body.  He also is running fevers on and off.  He has a raspy wet cough that won't go away.  He has mysterious stomach aches unrelated to eating.   He has become allergic to more foods with more severe reactions.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Over an hour after the vaccination the patient left arm became swollen, patient developed a high fever. Patient was treated by a physician.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old male patient. The patient had no known allergies. Pertinent medical history includes hypercholesterolemia and vasomotor rhinitis. On 27-FEB-2013 the patient was vaccinated with PNEUMOVAX23 (lot number reported as H015749) (0.5 ml, intramuscular). Several days after receiving PNEUMOVAX23, on 02-MAR-2013 the patient experienced redness, tenderness and warmth at injection site. The patient notified unspecified primary physician and was prescribed antibiotic, cephalexin. Patient visited an Urgent Care Facility for medical attention on 07-MAR-2013. Reason for visit was unspecified. The patient was treated for unspecified reasons by a physician. Patient currently prescribed simvastatin. Pharmacist stated that the patient was fully recovered at the time of report. There was no laboratory diagnostics study performed. Action taken for PNEUMOVAX23 and causality were not provided. This is one of several reports received from the same source. Additional information is not expected.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Cough, Induration, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a physician refers to a 9 year old male patient with asthma. The patient's medical history included respiratory infections. On 04-MAR-2013 the patient was vaccinated with PNEUMOVAX23 (lot # H010916, expired date 15-FEB-2014) (0.5 ml, intramuscular in the right arm). Concomitant medication was asthma medication. The patient was schedule to receive the PNEUMOVAX23 prior to an unspecified immune workup (titers were scheduled to be drawn approximately 4 weeks after the PNEUMOVAX23 was given). The patient did not have an acute illness at time of the administration of the PNEUMOVAX23. The patient had received PNEUMOVAX23 at 5 years old on an unspecified date and it was well tolerated. Initially on 04-MAR-2013 the patient was fine. The next morning, 05-MAR-2013, the patient complained of significant pain at injection site. On the night of 05-MAR-2013, approximately 24 hrs after receiving the PNEUMOVAX23, the unspecified patient complained about pain around injection site. There was slight redness at injection site and the patient had a low grade fever. The unspecified patient was seen in the physician's office on 07-MAR-2013 for medical attention, and the injection site was significantly red with swelling and pain. Physician diagnosed symptoms as cellulitis with induration. Patient had also experienced a fever of 104F on the night of 06-MAR-2013. Patient did not have a fever on 07-MAR-2013. Patient was coughing and wheezing as well. Patient had a history of asthma. Physician prescribed amoxicillin, AUGMENTIN for cellulitis and acetaminophen and ibuprofen as needed for discomfort as well as cool compresses on affected area. There was no laboratory diagnostics study performed. The outcome was unknown at the time of report. The action taken and causality were not provided. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia, Wheezing
Clinical narrative: This spontaneous report as received from a physician refers to a 9 year old male patient with asthma. The patient's medical history included respiratory infections. On 04-MAR-2013 the patient was vaccinated with PNEUMOVAX23 (lot # H010916, expired date 15-FEB-2014) (0.5 ml, intramuscular in the right arm). Concomitant medication was asthma medication. The patient was schedule to receive the PNEUMOVAX23 prior to an unspecified immune workup (titers were scheduled to be drawn approximately 4 weeks after the PNEUMOVAX23 was given). The patient did not have an acute illness at time of the administration of the PNEUMOVAX23. The patient had received PNEUMOVAX23 at 5 years old on an unspecified date and it was well tolerated. Initially on 04-MAR-2013 the patient was fine. The next morning, 05-MAR-2013, the patient complained of significant pain at injection site. On the night of 05-MAR-2013, approximately 24 hrs after receiving the PNEUMOVAX23, the unspecified patient complained about pain around injection site. There was slight redness at injection site and the patient had a low grade fever. The unspecified patient was seen in the physician's office on 07-MAR-2013 for medical attention, and the injection site was significantly red with swelling and pain. Physician diagnosed symptoms as cellulitis with induration. Patient had also experienced a fever of 104F on the night of 06-MAR-2013. Patient did not have a fever on 07-MAR-2013. Patient was coughing and wheezing as well. Patient had a history of asthma. Physician prescribed amoxicillin, AUGMENTIN for cellulitis and acetaminophen and ibuprofen as needed for discomfort as well as cool compresses on affected area. There was no laboratory diagnostics study performed. The outcome was unknown at the time of report. The action taken and causality were not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. It was reported that, on an unknown date, the patient may have received a dose of ZOSTAVAX (lot number, dose and route unspecified) that had expired on April 2012. This occurred with another unspecified pharmacist and the pharmacist was not sure if the patient did receive ZOSTAVAX or not. No concomitant medications were reported. The patient was not experiencing any known symptoms. Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Erythema, Fatigue, Injection site erythema, Injection site inflammation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 36 year old female patient with allergy to sulfa. The patient had anxiety IBS (Irritable bowel syndrome), acne, sexually transmitted disease and obesity. The patient was not pregnant. On 04-MAR-2013 the patient was vaccinated with PNEUMOVAX23 (lot number reported as H015749) (0.5 ml, intramuscular in the right arm). Concomitant medications included INSALENZA (manufacturer unknown) and a TDAP vaccine. The PNEUMOVAX23 was the only vaccine administered in the right arm. On 06-MAR-2013 the patient visited an Urgent Care Facility. She was treated by a physician. The right arm site of injection was red and inflamed on an unknown date in March 2013. It was a 29cm by 16 cm reddened patch on her right arm which was hot to touch. Patient also complained of fatigue and chills on an unknown date in March 2013. Physician prescribed cephalexin. The pharmacist stated that the patient was fully recovered at the time of report. There was no laboratory diagnostics study performed. Action taken and causality were not provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 36 year old female patient with allergy to sulfa. The patient had anxiety IBS (Irritable bowel syndrome), acne, sexually transmitted disease and obesity. The patient was not pregnant. On 04-MAR-2013 the patient was vaccinated with PNEUMOVAX23 (lot number reported as H015749) (0.5 ml, intramuscular in the right arm). Concomitant medications included INSALENZA (manufacturer unknown) and a TDAP vaccine. The PNEUMOVAX23 was the only vaccine administered in the right arm. On 06-MAR-2013 the patient visited an Urgent Care Facility. She was treated by a physician. The right arm site of injection was red and inflamed on an unknown date in March 2013. It was a 29cm by 16 cm reddened patch on her right arm which was hot to touch. Patient also complained of fatigue and chills on an unknown date in March 2013. Physician prescribed cephalexin. The pharmacist stated that the patient was fully recovered at the time of report. There was no laboratory diagnostics study performed. Action taken and causality were not provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient with penicillin allergy, sulfonamides allergy and thioridazine allergy. On 12-FEB-2013 the patient was vaccinated with ZOSTAVAX lot # H011426 expiry date 12-SEP-2013, subcutaneous at the pharmacy. The patient had no concomitant medication and no pertinent medical history. On an unspecified date in 2013 the patient was diagnosed with shingles by her unspecified physician. The patient was prescribed with ZOVIRAX for treatment. No lab test was done. The outcome of shingles was reported as not recovered/not resolved. The patient sought medical attention via office visit. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a consumer concerning her son of unknown age. On an unknown date, approximately in April 2012 (11 months ago), the patient was vaccinated with first dose of GARDASIL (lot number, expiry date, dose and route unspecified). The patient had received the first and second dosages of GARDASIL in accordance with the correct regimen, but did not get third dose of GARDASIL (missed his third dosage). No concomitant medications were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an healthcare worker refers to a patient of unknown age and unspecified gender. The reporter stated on an unknown date the patient was vaccinated with a dose of GARDASIL that past the recommended scheduled date. Lot# and administration route was unspecified. The reporter did not know if the patient was late for the second or the third dose. The reporter also didn't know the date of the vaccination. No adverse effect reported. Outcome of event was unknown. It was unspecified if the patient sought medical attention or not. 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 a registered nurse refers to a patient of unknown age. On 06-MAR-2013 the patient was vaccinated with PROQUAD (merck) (lot number not provided) 0.5 ml once, subcutaneous. The PROQUAD (merck) had been stored in the refrigerated at 4-5 degrees C. for 384 hours. No adverse effect reported. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Dyspnoea, Erythema, Lip swelling, Pruritus, Swelling face
Clinical narrative: Initial report was received from a consumer on 05 March 2013. A 19-year-old male patient, with past medical history of hay fever allergy, received dose two of a left deltoid injection of TYPHIM VI, sanofi pasteur SA, lot number G1542-1 (route not reported) and dose two of a left deltoid injection of YF VAX, sanofi pasteur Inc., lot number UH587AA (route not reported) on 15 February 2013 (also reported as "or 08 February 2013"). On same day, 15 February 2013 (also reported as "or 08 February 2013"), within 15 minutes, the patient developed full body hives and swollen lips. The patient was seen by base physician (MD), who sent patient to the hospital emergency room (ER), where he stayed for six hours. The patient was not admitted to the hospital. No laboratory or diagnostic testing was reported. Treatments included BENADRYL and Prednisone 50 milligram (mg), with second dose of prednisone the next day. The patient had no illness at time of vaccination. The patient was reported as recovered on an unspecified date. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Throat tightness
Clinical narrative: Initial report was received from a consumer on 05 March 2013. A 19-year-old male patient, with past medical history of hay fever allergy, received dose two of a left deltoid injection of TYPHIM VI, sanofi pasteur SA, lot number G1542-1 (route not reported) and dose two of a left deltoid injection of YF VAX, sanofi pasteur Inc., lot number UH587AA (route not reported) on 15 February 2013 (also reported as "or 08 February 2013"). On same day, 15 February 2013 (also reported as "or 08 February 2013"), within 15 minutes, the patient developed full body hives and swollen lips. The patient was seen by base physician (MD), who sent patient to the hospital emergency room (ER), where he stayed for six hours. The patient was not admitted to the hospital. No laboratory or diagnostic testing was reported. Treatments included BENADRYL and Prednisone 50 milligram (mg), with second dose of prednisone the next day. The patient had no illness at time of vaccination. The patient was reported as recovered on an unspecified date. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Lip swelling, Urticaria
Clinical narrative: Initial report was received from a consumer on 05 March 2013. A 19-year-old male patient, with past medical history of hay fever allergy, received dose two of a left deltoid injection of TYPHIM VI, sanofi pasteur SA, lot number G1542-1 (route not reported) and dose two of a left deltoid injection of YF VAX, sanofi pasteur Inc., lot number UH587AA (route not reported) on 15 February 2013 (also reported as "or 08 February 2013"). On same day, 15 February 2013 (also reported as "or 08 February 2013"), within 15 minutes, the patient developed full body hives and swollen lips. The patient was seen by base physician (MD), who sent patient to the hospital emergency room (ER), where he stayed for six hours. The patient was not admitted to the hospital. No laboratory or diagnostic testing was reported. Treatments included BENADRYL and Prednisone 50 milligram (mg), with second dose of prednisone the next day. The patient had no illness at time of vaccination. The patient was reported as recovered on an unspecified date. Documents held by sender: None.
Age: 24.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Chills, Headache, Vomiting
Clinical narrative: Dx w/myopericarditis related to smallpx. Chest pain.
Age: 24.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Myopericarditis, Vaccination complication
Clinical narrative: Dx w/myopericarditis related to smallpx. Chest pain.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Anxiety, Blood creatine phosphokinase MB normal, Blood creatine phosphokinase normal, C-reactive protein normal, Differential white blood cell count normal
Clinical narrative: 25 year old male who received his primary smallpox vaccination (SPV) on 08 MAR. He had no preceding illness or complaint. He was well until the evening of 13MAR when while at work in the PICU, he noted a very brief sense of anxiousness (lasting seconds) without any other feelings/sensations. Approximately 4-5 hours later he was awakened at 0500 from sleep with "rigors"--he c/o a stiff/clenched jaw; bilateral upper extremities "shaking" and bilat. lower extremities "twitching" for 30 mins. The UE and LE sxs were relieved by "walking around". Although the shivering/shaking (rigors) ceased, a sense of anxiety (feeling of doom) and difficulty falling asleep due to 'his mind racing' remained. He was evaluated in the ER at which time VS, PE, and EKG were normal. While he had no chest pain, he did complain of mild dyspnea and tachycardia. While initially his anxiety was pervasive, over the past 3 days he feels it has lessened somewhat (from 100% to now 70%) and is intermittent rather than continuous. He still has difficulty falling asleep, ruminating about both the nature of this reaction and his upcoming deployment. There is no past personal or family history of anxiety disorders, depression, dysthymia, etc. His only medication is the Valium prescribed for sleep until two days ago. Once he falls asleep, he is able to sleep for hours. There are no intrusive thoughts or dreams. His SPV site is progressing as expected.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Full blood count normal, Insomnia, Metabolic function test normal, Muscle twitching, Pallor
Clinical narrative: 25 year old male who received his primary smallpox vaccination (SPV) on 08 MAR. He had no preceding illness or complaint. He was well until the evening of 13MAR when while at work in the PICU, he noted a very brief sense of anxiousness (lasting seconds) without any other feelings/sensations. Approximately 4-5 hours later he was awakened at 0500 from sleep with "rigors"--he c/o a stiff/clenched jaw; bilateral upper extremities "shaking" and bilat. lower extremities "twitching" for 30 mins. The UE and LE sxs were relieved by "walking around". Although the shivering/shaking (rigors) ceased, a sense of anxiety (feeling of doom) and difficulty falling asleep due to 'his mind racing' remained. He was evaluated in the ER at which time VS, PE, and EKG were normal. While he had no chest pain, he did complain of mild dyspnea and tachycardia. While initially his anxiety was pervasive, over the past 3 days he feels it has lessened somewhat (from 100% to now 70%) and is intermittent rather than continuous. He still has difficulty falling asleep, ruminating about both the nature of this reaction and his upcoming deployment. There is no past personal or family history of anxiety disorders, depression, dysthymia, etc. His only medication is the Valium prescribed for sleep until two days ago. Once he falls asleep, he is able to sleep for hours. There are no intrusive thoughts or dreams. His SPV site is progressing as expected.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Red blood cell sedimentation rate normal, Tremor, Trismus, Troponin T normal, Urine analysis normal
Clinical narrative: 25 year old male who received his primary smallpox vaccination (SPV) on 08 MAR. He had no preceding illness or complaint. He was well until the evening of 13MAR when while at work in the PICU, he noted a very brief sense of anxiousness (lasting seconds) without any other feelings/sensations. Approximately 4-5 hours later he was awakened at 0500 from sleep with "rigors"--he c/o a stiff/clenched jaw; bilateral upper extremities "shaking" and bilat. lower extremities "twitching" for 30 mins. The UE and LE sxs were relieved by "walking around". Although the shivering/shaking (rigors) ceased, a sense of anxiety (feeling of doom) and difficulty falling asleep due to 'his mind racing' remained. He was evaluated in the ER at which time VS, PE, and EKG were normal. While he had no chest pain, he did complain of mild dyspnea and tachycardia. While initially his anxiety was pervasive, over the past 3 days he feels it has lessened somewhat (from 100% to now 70%) and is intermittent rather than continuous. He still has difficulty falling asleep, ruminating about both the nature of this reaction and his upcoming deployment. There is no past personal or family history of anxiety disorders, depression, dysthymia, etc. His only medication is the Valium prescribed for sleep until two days ago. Once he falls asleep, he is able to sleep for hours. There are no intrusive thoughts or dreams. His SPV site is progressing as expected.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Alanine aminotransferase normal, Anion gap normal, Anxiety, Aspartate aminotransferase normal, Basophil count normal
Clinical narrative: 25 year old male who received his primary smallpox vaccination (SPV) on 08 MAR. He had no preceding illness or complaint. He was well until the evening of 13MAR when while at work in the PICU, he noted a very brief sense of anxiousness (lasting seconds) without any other feelings/sensations. Approximately 4-5 hours later he was awakened at 0500 from sleep with "rigors"--he c/o a stiff/clenched jaw; bilateral upper extremities "shaking" and bilat. lower extremities "twitching" for 30 mins. The UE and LE sxs were relieved by "walking around". Although the shivering/shaking (rigors) ceased, a sense of anxiety (feeling of doom) and difficulty falling asleep due to 'his mind racing' remained. He was evaluated in the ER at which time VS, PE, and EKG were normal. While he had no chest pain, he did complain of mild dyspnea and tachycardia. While initially his anxiety was pervasive, over the past 3 days he feels it has lessened somewhat (from 100% to now 70%) and is intermittent rather than continuous. He still has difficulty falling asleep, ruminating about both the nature of this reaction and his upcoming deployment. There is no past personal or family history of anxiety disorders, depression, dysthymia, etc. His only medication is the Valium prescribed for sleep until two days ago. Once he falls asleep, he is able to sleep for hours. There are no intrusive thoughts or dreams. His SPV site is progressing as expected.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Basophil percentage decreased, Bilirubin urine, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal
Clinical narrative: 25 year old male who received his primary smallpox vaccination (SPV) on 08 MAR. He had no preceding illness or complaint. He was well until the evening of 13MAR when while at work in the PICU, he noted a very brief sense of anxiousness (lasting seconds) without any other feelings/sensations. Approximately 4-5 hours later he was awakened at 0500 from sleep with "rigors"--he c/o a stiff/clenched jaw; bilateral upper extremities "shaking" and bilat. lower extremities "twitching" for 30 mins. The UE and LE sxs were relieved by "walking around". Although the shivering/shaking (rigors) ceased, a sense of anxiety (feeling of doom) and difficulty falling asleep due to 'his mind racing' remained. He was evaluated in the ER at which time VS, PE, and EKG were normal. While he had no chest pain, he did complain of mild dyspnea and tachycardia. While initially his anxiety was pervasive, over the past 3 days he feels it has lessened somewhat (from 100% to now 70%) and is intermittent rather than continuous. He still has difficulty falling asleep, ruminating about both the nature of this reaction and his upcoming deployment. There is no past personal or family history of anxiety disorders, depression, dysthymia, etc. His only medication is the Valium prescribed for sleep until two days ago. Once he falls asleep, he is able to sleep for hours. There are no intrusive thoughts or dreams. His SPV site is progressing as expected.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blood calcium normal, Blood chloride normal, Blood creatine phosphokinase MB, Blood creatine phosphokinase normal, Blood creatinine normal
Clinical narrative: 25 year old male who received his primary smallpox vaccination (SPV) on 08 MAR. He had no preceding illness or complaint. He was well until the evening of 13MAR when while at work in the PICU, he noted a very brief sense of anxiousness (lasting seconds) without any other feelings/sensations. Approximately 4-5 hours later he was awakened at 0500 from sleep with "rigors"--he c/o a stiff/clenched jaw; bilateral upper extremities "shaking" and bilat. lower extremities "twitching" for 30 mins. The UE and LE sxs were relieved by "walking around". Although the shivering/shaking (rigors) ceased, a sense of anxiety (feeling of doom) and difficulty falling asleep due to 'his mind racing' remained. He was evaluated in the ER at which time VS, PE, and EKG were normal. While he had no chest pain, he did complain of mild dyspnea and tachycardia. While initially his anxiety was pervasive, over the past 3 days he feels it has lessened somewhat (from 100% to now 70%) and is intermittent rather than continuous. He still has difficulty falling asleep, ruminating about both the nature of this reaction and his upcoming deployment. There is no past personal or family history of anxiety disorders, depression, dysthymia, etc. His only medication is the Valium prescribed for sleep until two days ago. Once he falls asleep, he is able to sleep for hours. There are no intrusive thoughts or dreams. His SPV site is progressing as expected.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein normal
Clinical narrative: 25 year old male who received his primary smallpox vaccination (SPV) on 08 MAR. He had no preceding illness or complaint. He was well until the evening of 13MAR when while at work in the PICU, he noted a very brief sense of anxiousness (lasting seconds) without any other feelings/sensations. Approximately 4-5 hours later he was awakened at 0500 from sleep with "rigors"--he c/o a stiff/clenched jaw; bilateral upper extremities "shaking" and bilat. lower extremities "twitching" for 30 mins. The UE and LE sxs were relieved by "walking around". Although the shivering/shaking (rigors) ceased, a sense of anxiety (feeling of doom) and difficulty falling asleep due to 'his mind racing' remained. He was evaluated in the ER at which time VS, PE, and EKG were normal. While he had no chest pain, he did complain of mild dyspnea and tachycardia. While initially his anxiety was pervasive, over the past 3 days he feels it has lessened somewhat (from 100% to now 70%) and is intermittent rather than continuous. He still has difficulty falling asleep, ruminating about both the nature of this reaction and his upcoming deployment. There is no past personal or family history of anxiety disorders, depression, dysthymia, etc. His only medication is the Valium prescribed for sleep until two days ago. Once he falls asleep, he is able to sleep for hours. There are no intrusive thoughts or dreams. His SPV site is progressing as expected.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Carbon dioxide normal, Chills, Chromaturia, Dyspnoea, Electrocardiogram normal
Clinical narrative: 25 year old male who received his primary smallpox vaccination (SPV) on 08 MAR. He had no preceding illness or complaint. He was well until the evening of 13MAR when while at work in the PICU, he noted a very brief sense of anxiousness (lasting seconds) without any other feelings/sensations. Approximately 4-5 hours later he was awakened at 0500 from sleep with "rigors"--he c/o a stiff/clenched jaw; bilateral upper extremities "shaking" and bilat. lower extremities "twitching" for 30 mins. The UE and LE sxs were relieved by "walking around". Although the shivering/shaking (rigors) ceased, a sense of anxiety (feeling of doom) and difficulty falling asleep due to 'his mind racing' remained. He was evaluated in the ER at which time VS, PE, and EKG were normal. While he had no chest pain, he did complain of mild dyspnea and tachycardia. While initially his anxiety was pervasive, over the past 3 days he feels it has lessened somewhat (from 100% to now 70%) and is intermittent rather than continuous. He still has difficulty falling asleep, ruminating about both the nature of this reaction and his upcoming deployment. There is no past personal or family history of anxiety disorders, depression, dysthymia, etc. His only medication is the Valium prescribed for sleep until two days ago. Once he falls asleep, he is able to sleep for hours. There are no intrusive thoughts or dreams. His SPV site is progressing as expected.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Eosinophil count normal, Eosinophil percentage, Full blood count normal, Glucose urine absent, Haematocrit normal
Clinical narrative: 25 year old male who received his primary smallpox vaccination (SPV) on 08 MAR. He had no preceding illness or complaint. He was well until the evening of 13MAR when while at work in the PICU, he noted a very brief sense of anxiousness (lasting seconds) without any other feelings/sensations. Approximately 4-5 hours later he was awakened at 0500 from sleep with "rigors"--he c/o a stiff/clenched jaw; bilateral upper extremities "shaking" and bilat. lower extremities "twitching" for 30 mins. The UE and LE sxs were relieved by "walking around". Although the shivering/shaking (rigors) ceased, a sense of anxiety (feeling of doom) and difficulty falling asleep due to 'his mind racing' remained. He was evaluated in the ER at which time VS, PE, and EKG were normal. While he had no chest pain, he did complain of mild dyspnea and tachycardia. While initially his anxiety was pervasive, over the past 3 days he feels it has lessened somewhat (from 100% to now 70%) and is intermittent rather than continuous. He still has difficulty falling asleep, ruminating about both the nature of this reaction and his upcoming deployment. There is no past personal or family history of anxiety disorders, depression, dysthymia, etc. His only medication is the Valium prescribed for sleep until two days ago. Once he falls asleep, he is able to sleep for hours. There are no intrusive thoughts or dreams. His SPV site is progressing as expected.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Haemoglobin normal, Haemoglobin urine absent, Initial insomnia, Joint stiffness, Lymphocyte count normal
Clinical narrative: 25 year old male who received his primary smallpox vaccination (SPV) on 08 MAR. He had no preceding illness or complaint. He was well until the evening of 13MAR when while at work in the PICU, he noted a very brief sense of anxiousness (lasting seconds) without any other feelings/sensations. Approximately 4-5 hours later he was awakened at 0500 from sleep with "rigors"--he c/o a stiff/clenched jaw; bilateral upper extremities "shaking" and bilat. lower extremities "twitching" for 30 mins. The UE and LE sxs were relieved by "walking around". Although the shivering/shaking (rigors) ceased, a sense of anxiety (feeling of doom) and difficulty falling asleep due to 'his mind racing' remained. He was evaluated in the ER at which time VS, PE, and EKG were normal. While he had no chest pain, he did complain of mild dyspnea and tachycardia. While initially his anxiety was pervasive, over the past 3 days he feels it has lessened somewhat (from 100% to now 70%) and is intermittent rather than continuous. He still has difficulty falling asleep, ruminating about both the nature of this reaction and his upcoming deployment. There is no past personal or family history of anxiety disorders, depression, dysthymia, etc. His only medication is the Valium prescribed for sleep until two days ago. Once he falls asleep, he is able to sleep for hours. There are no intrusive thoughts or dreams. His SPV site is progressing as expected.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal
Clinical narrative: 25 year old male who received his primary smallpox vaccination (SPV) on 08 MAR. He had no preceding illness or complaint. He was well until the evening of 13MAR when while at work in the PICU, he noted a very brief sense of anxiousness (lasting seconds) without any other feelings/sensations. Approximately 4-5 hours later he was awakened at 0500 from sleep with "rigors"--he c/o a stiff/clenched jaw; bilateral upper extremities "shaking" and bilat. lower extremities "twitching" for 30 mins. The UE and LE sxs were relieved by "walking around". Although the shivering/shaking (rigors) ceased, a sense of anxiety (feeling of doom) and difficulty falling asleep due to 'his mind racing' remained. He was evaluated in the ER at which time VS, PE, and EKG were normal. While he had no chest pain, he did complain of mild dyspnea and tachycardia. While initially his anxiety was pervasive, over the past 3 days he feels it has lessened somewhat (from 100% to now 70%) and is intermittent rather than continuous. He still has difficulty falling asleep, ruminating about both the nature of this reaction and his upcoming deployment. There is no past personal or family history of anxiety disorders, depression, dysthymia, etc. His only medication is the Valium prescribed for sleep until two days ago. Once he falls asleep, he is able to sleep for hours. There are no intrusive thoughts or dreams. His SPV site is progressing as expected.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Monocyte count normal, Monocyte percentage, Muscle twitching, Neutrophil count normal, Neutrophil percentage
Clinical narrative: 25 year old male who received his primary smallpox vaccination (SPV) on 08 MAR. He had no preceding illness or complaint. He was well until the evening of 13MAR when while at work in the PICU, he noted a very brief sense of anxiousness (lasting seconds) without any other feelings/sensations. Approximately 4-5 hours later he was awakened at 0500 from sleep with "rigors"--he c/o a stiff/clenched jaw; bilateral upper extremities "shaking" and bilat. lower extremities "twitching" for 30 mins. The UE and LE sxs were relieved by "walking around". Although the shivering/shaking (rigors) ceased, a sense of anxiety (feeling of doom) and difficulty falling asleep due to 'his mind racing' remained. He was evaluated in the ER at which time VS, PE, and EKG were normal. While he had no chest pain, he did complain of mild dyspnea and tachycardia. While initially his anxiety was pervasive, over the past 3 days he feels it has lessened somewhat (from 100% to now 70%) and is intermittent rather than continuous. He still has difficulty falling asleep, ruminating about both the nature of this reaction and his upcoming deployment. There is no past personal or family history of anxiety disorders, depression, dysthymia, etc. His only medication is the Valium prescribed for sleep until two days ago. Once he falls asleep, he is able to sleep for hours. There are no intrusive thoughts or dreams. His SPV site is progressing as expected.