chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: On 09/30/11, patient came to report to me that after the flu shot she could not move (date of shot was 09/06/2011). She had called & report it. She is ok now.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt stated pain at injection site for 28 days.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Seizure after FLUZONE PF administered.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Feeling cold, Headache, Muscle twitching, Myalgia
Clinical narrative: About 30 minutes after receiving her 2nd HPV (10/11) vaccine so came back to the department. Patient laid down with legs elevated & observed for about 40 min. Patient left the clinic without any symptoms. Seen by MD 2 days later reporting head pressure the evening of the day she received her vaccine; on 10/12 woke up feeling exhausted & slept most of the day. Also noted frequent twitching in her legs & shoulders; mild muscle aches & cold feeling as well. Only had a low grade fever with her first HPV vaccine. No treatment.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Somnolence
Clinical narrative: About 30 minutes after receiving her 2nd HPV (10/11) vaccine so came back to the department. Patient laid down with legs elevated & observed for about 40 min. Patient left the clinic without any symptoms. Seen by MD 2 days later reporting head pressure the evening of the day she received her vaccine; on 10/12 woke up feeling exhausted & slept most of the day. Also noted frequent twitching in her legs & shoulders; mild muscle aches & cold feeling as well. Only had a low grade fever with her first HPV vaccine. No treatment.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Discomfort, Local swelling, Pruritus, Rash, Swelling face
Clinical narrative: Within 24 hours, son began to complain that he itched, especially head and neck. About 12 hours after that, he developed rash on face and neck, and both became very swollen. Then rash spread to extremities and abdomen. Lasted 10 days or so. Used BENADRYL, but he was very uncomfortable.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Chest discomfort, Dyspnoea, Electrocardiogram, Sensation of pressure
Clinical narrative: Began feeling SOB with chest pressure into throat. No wheezing. Taken to ED for evaluation. Neb trmts & steroids given. Admitted to hospital. D'cd 24 h later
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Admit 10/1/2011 to hospital for febrile seizures.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reaction at injection site, soreness, swelling, warmth over a 4 day period.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Injection site erythema, Nodule, Pain, Skin warm
Clinical narrative: Pain, redness, nodule, warmth to touch. Injection given Monday 9/24/11 at 10am. Noticed redness 9/27/11 which continued to progress from injection site down arm. Treated with Prednisone pak - 6 day course.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Rash generalised
Clinical narrative: Day after influenza vaccination client stated felt "punky" not great - noticed arm had "rash" - 48 hours after rash all over 60% - groin, under arms, sides of body (under arms) back of shoulders - not itchy.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Left deltoid site, redness, slight edema, noted pt. still c/o pain at injection site. (Soreness to touch). 2 cm x 2.5 cm size/side.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Infection, Oedema peripheral, Rash erythematous
Clinical narrative: Pt called on 10/5 in the morning complaining of red rash on her arm below the site of injections, arm was swollen to the elbow and difficult to move. Advised pt to see MD - she was seen and MD thought the condition was an infection and prescribed KEFLEX. She is to return to MD on 10/10/2011.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Pruritus
Clinical narrative: Pt reports a rash starting from the injection site (deltoid) to the elbow with severe itching at the palm of the hand. Pt was given authorization by her physician to get a flu shot. Pt. has an EPIPEN d/t previous rx to said products that caused swelling of tongue/throat. Rx subsiding with BENADRYL.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid area of upper arm, very hot, red & swollen. Not painful, but itchy. Given prescription for MOTRIN & BENADRYL.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased, Pain in extremity
Clinical narrative: Pt had pain in left arm and had problems moving it. Redness and swelling was seen at administration site. Cold compress was recommended with TYLENOL and BENADRYL prn.
Age: 27.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Rash erythematous, Vaccination complication
Clinical narrative: Patient was seen on 31 May with complaints of red spots on chest and back. Received smallpox vaccine two weeks prior. Pt noticed mild red lesions on chest & back. Provider stated it was a mild reaction from smallpox vaccine & prescribed antihistamine for itch.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Muscular weakness, Pain in extremity
Clinical narrative: Swollen, red knot at site of injection, radiating pain down arm, limited ability in arm PM. Patient given injection of corticosteroid at ER, MEDROL dose pak, BACTRIM DS, and VICOPROFEN.
Age: 55.0
Sex: U
Vaccine: FLU3
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting, diarrhea.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The patient presented to the pharmacy on 10-4-11 and underneath where the PNEUMOVAX was administered arm was red and swollen.
Age: 69.0
Sex: U
Vaccine: FLU3
Symptoms: Chills, Cough, Delusion, Dyspnoea, Feeling abnormal
Clinical narrative: Chills, shaking, heart palpitations, delusions - lasted all night long. Actually felt as it were dying. Dry cough, shortness of breath.
Age: 69.0
Sex: U
Vaccine: FLU3
Symptoms: Palpitations, Tremor
Clinical narrative: Chills, shaking, heart palpitations, delusions - lasted all night long. Actually felt as it were dying. Dry cough, shortness of breath.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Prolonged pain/muscle tenderness at injection site using heat to area.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Red area noted on (R) thigh evening of 10/4 worse on morning of 10/5. Brought to office. (R) thigh with large reddened area starting around DTaP injection site & progressing medially on thigh. Measurement of redness/induration: 3 1/4" x 1 3/4". Non-tender. Treated with KEFLEX.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Heart rate increased, Heart rate irregular, Malaise
Clinical narrative: Rapid, irregular heart rate; dizziness; syncope; malaise; headache; nausea. Symptoms started about 2h post-dose and remained intense overnight for about 12h; subsided 48h post dose.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Syncope, Vaccine positive rechallenge
Clinical narrative: Rapid, irregular heart rate; dizziness; syncope; malaise; headache; nausea. Symptoms started about 2h post-dose and remained intense overnight for about 12h; subsided 48h post dose.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Rash generalised, Upper extremity mass
Clinical narrative: Pt received both Influenza & Pneumonia vaccine. State Tues AM (next day) arm was sore & looked at it. It was all red with a lump. The underside of arm was swollen & red. She had a rash that developed over body. Went to MD & was given antibiotics for red/swollen arm. It is getting better but not fully resolved.
Age: 11.0
Sex: M
Vaccine: FLUN3, MNQ, TDAP
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Swelling, pain, redness 6 x 8 cm (R) deltoid.
Age: 1.03
Sex: M
Vaccine: FLU3, HEPA, PNC13, VARCEL
Symptoms: Inflammation, Injection site rash
Clinical narrative: Shots given 9/23/11 (VARIVAX & flu shot). Rash (local inflammatory reaction) on (R) thigh developed about 7-8 days later.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Induration, Mass
Clinical narrative: Patient's arm immediately formed a large hard knot. Rph hit a capillary.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Back pain, Injection site discomfort, Injection site joint movement impairment, Injection site pain, Injection site warmth
Clinical narrative: Shoulder was very sore to the touch & had very limited movement during the 1st 24 hrs. I could not sleep the 1st night. The effected area grew to include entire upper arm, upper back on left side, & the shoulder. Discomfort lasted almost an entire week. Arm & back were hot. This was only the left arm, where the PNEUMOVAX 23 was given.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Insomnia, Skin warm
Clinical narrative: Shoulder was very sore to the touch & had very limited movement during the 1st 24 hrs. I could not sleep the 1st night. The effected area grew to include entire upper arm, upper back on left side, & the shoulder. Discomfort lasted almost an entire week. Arm & back were hot. This was only the left arm, where the PNEUMOVAX 23 was given.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Confusional state, Pyrexia
Clinical narrative: Flu vaccine administered on 9/22/11. Spouse called on 9/23/11 reporting fever of 104.0 degree F axillary. Reports fever started at 1100 that morning and was 100.0 degree F axillary. Pt noted to have increase confusion and fidgeting.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test negative, Dizziness, Palpitations, Paraesthesia, Throat tightness
Clinical narrative: 1339 9/21/11. Pt came back to clinic with complaints of tingling on the (R) side of face at approx. 1330. She also complained palpitations and dizziness.. Pt states that "sometimes when I eat eggs. Sometimes my throat closes up... I don't go to the doctor... It will eventually go away.." VS 110/58, HR 80, R 14, T 97.4. 1357: VS 110/54, P 78, R 12. PT still complaining of tinglings no localized redness, swelling to site of injection. Head was normocephalic, no swelling or ache. Pt stated she has take "BENADRYL as sleep aid... I have taken stronger narcotics: BENDARYL 50 mg PO given @ 1400. Pt stated "I was already having a bad day". VS at 1415 95/50 R 16 HR 75. Pt states that she is feeling better. Advised her that she would need assistance driving home due to the side effects of the medication. VS at 1430 94/52 R 14 HR 60 T 98.2 Face "felling a lot better.." Stated that she ahs had allergy testing and is not allergic to eggs. 1440 --> patient states my face "is not tingling anymore.." Management coordinated ride for patient to safely get home.. Advised patient to call 911 if symptoms return at home. Also advised her to follow up with her primary care doctor about allergies and symptoms. Dr. contacted and he is aware of situation. No new orders given.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed red, raised, warm, tender to touch area on her right inner arm near arm pit area. This is the same arm PNEUMOVAX was given she took 1 tab of BENADRYL on night of Oct 12th.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: None.
Age: 52.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Chills, Headache, Heart rate increased, Pain, Pyrexia
Clinical narrative: Body aches, chills, headache, heart rate increase, fever -onset 1 am (10.14.11) taking ibuprofen.
Age: 89.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Fall, Limb operation, Lower limb fracture, Nuclear magnetic resonance imaging
Clinical narrative: Initial report was received 03 October 2011 from a health care professional. A male patient (age not reported) who had a history of a stroke and right sided weakness, had received FLUZONE HIGH-DOSE (lot number, route, site and date of administration not reported) and an unspecified amount of time later, the patient was reported to have felt weak all day. Later in the evening, the patient fell and broke their leg. Outcome was not reported. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 89.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Weight bearing difficulty, X-ray
Clinical narrative: Initial report was received 03 October 2011 from a health care professional. A male patient (age not reported) who had a history of a stroke and right sided weakness, had received FLUZONE HIGH-DOSE (lot number, route, site and date of administration not reported) and an unspecified amount of time later, the patient was reported to have felt weak all day. Later in the evening, the patient fell and broke their leg. Outcome was not reported. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 89.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Fall, Lower limb fracture
Clinical narrative: Initial report was received 03 October 2011 from a health care professional. A male patient (age not reported) who had a history of a stroke and right sided weakness, had received FLUZONE HIGH-DOSE (lot number, route, site and date of administration not reported) and an unspecified amount of time later, the patient was reported to have felt weak all day. Later in the evening, the patient fell and broke their leg. Outcome was not reported. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Diplegia, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Monoplegia
Clinical narrative: Pt had diffuse upper extremity parasthesias, then progressive weakness over the next two weeks leading to hospitalization under the care of a neurologist.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Paraesthesia
Clinical narrative: Pt had diffuse upper extremity parasthesias, then progressive weakness over the next two weeks leading to hospitalization under the care of a neurologist.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Borrelia test, Diagnostic procedure, Hypoaesthesia, Paraesthesia, Peripheral coldness
Clinical narrative: Pt had diffuse upper extremity parasthesias, then progressive weakness over the next two weeks leading to hospitalization under the care of a neurologist.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Viral test
Clinical narrative: Pt had diffuse upper extremity parasthesias, then progressive weakness over the next two weeks leading to hospitalization under the care of a neurologist.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL, DTAPIPVHIB, MMR, VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother states Rt arm is swollen & red about 4" circle, warm to touch, uncomfortable, no fever. Will use a cold pack & cloth on arm & see if it gets better; if not may go to ED this afternoon.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Excessive eye blinking, Pain in jaw, Pyrexia, Swelling
Clinical narrative: High fever for three days. After couple months started flutter eyelid, pain and swollen jaw and behind ear - left side.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site pain, Injection site reaction, Injection site scar, Pruritus generalised
Clinical narrative: Very sensitive and painful injection site with scarring. Occurrence of non-vesicular red bumps associated with intense itching appearing in crops diffusely disseminated all over the body including genitalia. Bumps heal with hyperpigmented remnant scarring.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Scar, Skin hyperpigmentation
Clinical narrative: Very sensitive and painful injection site with scarring. Occurrence of non-vesicular red bumps associated with intense itching appearing in crops diffusely disseminated all over the body including genitalia. Bumps heal with hyperpigmented remnant scarring.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: NECK, SHOULDER, ARM, HAND PAIN! Extreme and numbness. Pain meds and gabapentin. Now pain #6, no meds, 3 fingers numb.
Age: 1.01
Sex: F
Vaccine: HEP, MMR
Symptoms: Eye swelling, Eyelid oedema, Pyrexia, Rash
Clinical narrative: Slight rash that turned into fever. As days went by rash got worse. All over back, stomach, face and was spreading to limbs. Puffy and swollen eyes.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Dizziness, Nausea, Pain
Clinical narrative: Fever, shaking chills, body aches, nausea, weakness, dizziness
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever, shaking chills, body aches, nausea, weakness, dizziness
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: Slight fever, dizziness, headache.
Age: 1.27
Sex: U
Vaccine: MMR
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Information has been received from a physician concerning an approximately 24 months old patient who in October 2009, was vaccinated with the first dose of MMR II (Lot number 664655/0640Y, Exp. Date: May-2011). The physician reported that a "few months" after the first dose was given the patient was diagnosed with insulin dependent diabetes. The diagnosis of diabetes was made in June 2010. The patient was hospitalized on an unspecified date upon diagnosis. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Depression, Foetal disorder, Human chorionic gonadotropin positive, Intra-uterine death, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female with no pertinent medical history and no known drug reactions or allergies who on 24-MAY-2011 was vaccinated with the first dose of GARDASIL (dose, route and lot# not reported). On 27-JUL-2011 the patient was vaccinated intramuscularly with the second dose of GARDASIL (dose not reported), lot # 668229/1569Z and expiration date 05-APR-2013. There was no concomitant medication. On 23-AUG-2011, the patient came to the physician's office because she had a positive pregnancy test at home. Her last menstrual period was on 08-JUN-2011. On the same day, another urine pregnancy test was performed at the office confirmed the pregnancy. On 09-SEP-2011, an ultrasound was performed on the fetus, which found an omphalocele. Also, the left leg was missing a bone. The right leg was completely missing. On 14-SEP-2011, it was discovered by ultrasound that the fetus was no longer viable/alive (WAES1110USA00578B1). "A few days later" on an unspecified date, a dilation and evacuation was performed on the patient to remove the fetus. It was found that the fetus had no chromosomal abnormalities and that the karyotype was normal. A lot check has been initiated. Upon internal review, intrauterine death was considered to be an other important medical event. Follow up information was received from the nurse practitioner who confirmed that the patient had a "dilatation and extraction" (date not reported). The nurse practitioner did not know if the patient had recovered. The school based health nurse had reported that the patient "was having a hard time". The school nurse stated that the patient was not planning to use contraception. The nurse practitioner had been told that the patient was suffering from depression. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound antenatal screen abnormal, Uterine dilation and evacuation
Clinical narrative: Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female with no pertinent medical history and no known drug reactions or allergies who on 24-MAY-2011 was vaccinated with the first dose of GARDASIL (dose, route and lot# not reported). On 27-JUL-2011 the patient was vaccinated intramuscularly with the second dose of GARDASIL (dose not reported), lot # 668229/1569Z and expiration date 05-APR-2013. There was no concomitant medication. On 23-AUG-2011, the patient came to the physician's office because she had a positive pregnancy test at home. Her last menstrual period was on 08-JUN-2011. On the same day, another urine pregnancy test was performed at the office confirmed the pregnancy. On 09-SEP-2011, an ultrasound was performed on the fetus, which found an omphalocele. Also, the left leg was missing a bone. The right leg was completely missing. On 14-SEP-2011, it was discovered by ultrasound that the fetus was no longer viable/alive (WAES1110USA00578B1). "A few days later" on an unspecified date, a dilation and evacuation was performed on the patient to remove the fetus. It was found that the fetus had no chromosomal abnormalities and that the karyotype was normal. A lot check has been initiated. Upon internal review, intrauterine death was considered to be an other important medical event. Follow up information was received from the nurse practitioner who confirmed that the patient had a "dilatation and extraction" (date not reported). The nurse practitioner did not know if the patient had recovered. The school based health nurse had reported that the patient "was having a hard time". The school nurse stated that the patient was not planning to use contraception. The nurse practitioner had been told that the patient was suffering from depression. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Chromosome analysis normal, Foetal disorder, Intra-uterine death, Maternal exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female with no pertinent medical history and no known drug reactions or allergies who on 24-MAY-2011 was vaccinated with the first dose of GARDASIL (dose, route and lot# not reported). On 27-JUL-2011 the patient was vaccinated intramuscularly with the second dose of GARDASIL (dose not reported), lot # 668229/1569Z and expiration date 05-APR-2013. There was no concomitant medication. On 23-AUG-2011, the patient came to the physician's office because she had a positive pregnancy test at home. Her last menstrual period was on 08-JUN-2011. On the same day, another urine pregnancy test was performed at the office confirmed the pregnancy (WAES 1110USA00578). On 09-SEP-2011, an ultrasound was performed on the fetus, which found an omphalocele. Also, the left leg was missing a bone. The right leg was completely missing. On 14-SEP-2011, it was discovered by ultrasound that the fetus was no longer viable/alive (WAES1110USA00578B1). "A few days later" on an unspecified date, a dilation and evacuation was performed on the patient to remove the fetus. It was found that the fetus had no chromosomal abnormalities and that the karyotype was normal. A lot check has been initiated. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test urine positive, Ultrasound antenatal screen abnormal, Uterine dilation and evacuation
Clinical narrative: Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female with no pertinent medical history and no known drug reactions or allergies who on 24-MAY-2011 was vaccinated with the first dose of GARDASIL (dose, route and lot# not reported). On 27-JUL-2011 the patient was vaccinated intramuscularly with the second dose of GARDASIL (dose not reported), lot # 668229/1569Z and expiration date 05-APR-2013. There was no concomitant medication. On 23-AUG-2011, the patient came to the physician's office because she had a positive pregnancy test at home. Her last menstrual period was on 08-JUN-2011. On the same day, another urine pregnancy test was performed at the office confirmed the pregnancy (WAES 1110USA00578). On 09-SEP-2011, an ultrasound was performed on the fetus, which found an omphalocele. Also, the left leg was missing a bone. The right leg was completely missing. On 14-SEP-2011, it was discovered by ultrasound that the fetus was no longer viable/alive (WAES1110USA00578B1). "A few days later" on an unspecified date, a dilation and evacuation was performed on the patient to remove the fetus. It was found that the fetus had no chromosomal abnormalities and that the karyotype was normal. A lot check has been initiated. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Overdose, Throat tightness
Clinical narrative: Initial report was received on 03 October 2011 from a health care professional which involved a case of overdose. A female patient (date of birth not reported) had received on 30 September 2011 at 9 AM a one ml dose of FLUZONE (lot number, route and site of administration not reported) and three and a half hours later at 12:30 PM, experienced heaviness in her chest and felt her throat closing. The patient was sent to the ER (emergency room) for treatment. The patient's past medical history, concomitant medications and treatments were not reported. No further information was available at the time of the report. Outcome was recovered. The reporter for this case is the same as for case 2011-09484. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial test negative, Biopsy skin abnormal, Computerised tomogram normal, Cryptococcus test, Fungal test negative
Clinical narrative: Initial report was received on 03 October 2011 from scientific literature. Verbatim from the report: "A 68-year-old woman was referred for a 2-year history of an enlarging lesion on the right arm that developed several days after administration of the PNEUMOVAX 23 vaccine. She was healthy with no fever, malaise, or weight loss. The lesion began as a tender erythematous papule at the site of vaccination and increased in size with development of additional sites of involvement. Bacterial and fungal cultures, tuberculin skin testing, blood interferon-gamma release assay for tuberculosis, blastomycosis and coccidiomycosis serologies, cryptococcal antigen, and histoplasmosis urine antigen testing were all negative. Treatment with rifampin, azithromycin, and moxifloxican was initiated for presumed atypical mycobacterial infection without effect. Physical examination revealed a large (20 by 20 cm) erythematous plaque, with multiple hyperkeratotic papulonodules, involving the right arm (Fig 1). On the opposite arm, forearms, thighs, face and ears, there were erythematous macules coalescing into larger patches with overlying scale. Lymphadenopathy was absent. A biopsy specimen of the right arm revealed a mixed dermal infiltrate of foamy histiocytes, plasma cells, lymphocytes, neutrophils, and large pale histiocytes with feathery borders demonstrating emperipolesis (Fig 2, A). The large histiocytes were S-100 positive (Fig 2), B and CD1a negative. There was no evidence of microorganisms on acid-fast bacilli, Gram, and periodic acid Schiff stained sections. Previous biopsy specimens from multiple smaller lesions demonstrated similar findings. No lymphadenopathy was noted on a computed tomographic (CT) scan of the abdomen, chest, and pelvis. Over the course of 3 years under our care, the patient has shown partial improvement with multiple therapies, including topical, intralesional, and systemic corticosteroids; dapsone; isotretinoin; and liquid nitrogen cryotherapy." "In summary, our patient developed CRD after pneumococcal vaccination. As the eruption was temporally related and initially localized to the site of injection, we believe that an exaggerated immunological response to the vaccination is a likely cause for this case of CRD. Although, to our knowledge, RDD occurring post-vaccination has not been described previously, there has been a case of exaggerated antibody response in a child with RDD following rubella vaccination. Our experience suggests that vaccine-induced immune stimulation may provide an alternate trigger for inducing CRD." Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Gram stain negative, Histiocytosis haematophagic, Hyperkeratosis, Interferon gamma normal, Laboratory test normal
Clinical narrative: Initial report was received on 03 October 2011 from scientific literature. Verbatim from the report: "A 68-year-old woman was referred for a 2-year history of an enlarging lesion on the right arm that developed several days after administration of the PNEUMOVAX 23 vaccine. She was healthy with no fever, malaise, or weight loss. The lesion began as a tender erythematous papule at the site of vaccination and increased in size with development of additional sites of involvement. Bacterial and fungal cultures, tuberculin skin testing, blood interferon-gamma release assay for tuberculosis, blastomycosis and coccidiomycosis serologies, cryptococcal antigen, and histoplasmosis urine antigen testing were all negative. Treatment with rifampin, azithromycin, and moxifloxican was initiated for presumed atypical mycobacterial infection without effect. Physical examination revealed a large (20 by 20 cm) erythematous plaque, with multiple hyperkeratotic papulonodules, involving the right arm (Fig 1). On the opposite arm, forearms, thighs, face and ears, there were erythematous macules coalescing into larger patches with overlying scale. Lymphadenopathy was absent. A biopsy specimen of the right arm revealed a mixed dermal infiltrate of foamy histiocytes, plasma cells, lymphocytes, neutrophils, and large pale histiocytes with feathery borders demonstrating emperipolesis (Fig 2, A). The large histiocytes were S-100 positive (Fig 2), B and CD1a negative. There was no evidence of microorganisms on acid-fast bacilli, Gram, and periodic acid Schiff stained sections. Previous biopsy specimens from multiple smaller lesions demonstrated similar findings. No lymphadenopathy was noted on a computed tomographic (CT) scan of the abdomen, chest, and pelvis. Over the course of 3 years under our care, the patient has shown partial improvement with multiple therapies, including topical, intralesional, and systemic corticosteroids; dapsone; isotretinoin; and liquid nitrogen cryotherapy." "In summary, our patient developed CRD after pneumococcal vaccination. As the eruption was temporally related and initially localized to the site of injection, we believe that an exaggerated immunological response to the vaccination is a likely cause for this case of CRD. Although, to our knowledge, RDD occurring post-vaccination has not been described previously, there has been a case of exaggerated antibody response in a child with RDD following rubella vaccination. Our experience suggests that vaccine-induced immune stimulation may provide an alternate trigger for inducing CRD." Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Mycobacterium test negative, Nodule, Plasma cell disorder, Rash macular, Rash papular
Clinical narrative: Initial report was received on 03 October 2011 from scientific literature. Verbatim from the report: "A 68-year-old woman was referred for a 2-year history of an enlarging lesion on the right arm that developed several days after administration of the PNEUMOVAX 23 vaccine. She was healthy with no fever, malaise, or weight loss. The lesion began as a tender erythematous papule at the site of vaccination and increased in size with development of additional sites of involvement. Bacterial and fungal cultures, tuberculin skin testing, blood interferon-gamma release assay for tuberculosis, blastomycosis and coccidiomycosis serologies, cryptococcal antigen, and histoplasmosis urine antigen testing were all negative. Treatment with rifampin, azithromycin, and moxifloxican was initiated for presumed atypical mycobacterial infection without effect. Physical examination revealed a large (20 by 20 cm) erythematous plaque, with multiple hyperkeratotic papulonodules, involving the right arm (Fig 1). On the opposite arm, forearms, thighs, face and ears, there were erythematous macules coalescing into larger patches with overlying scale. Lymphadenopathy was absent. A biopsy specimen of the right arm revealed a mixed dermal infiltrate of foamy histiocytes, plasma cells, lymphocytes, neutrophils, and large pale histiocytes with feathery borders demonstrating emperipolesis (Fig 2, A). The large histiocytes were S-100 positive (Fig 2), B and CD1a negative. There was no evidence of microorganisms on acid-fast bacilli, Gram, and periodic acid Schiff stained sections. Previous biopsy specimens from multiple smaller lesions demonstrated similar findings. No lymphadenopathy was noted on a computed tomographic (CT) scan of the abdomen, chest, and pelvis. Over the course of 3 years under our care, the patient has shown partial improvement with multiple therapies, including topical, intralesional, and systemic corticosteroids; dapsone; isotretinoin; and liquid nitrogen cryotherapy." "In summary, our patient developed CRD after pneumococcal vaccination. As the eruption was temporally related and initially localized to the site of injection, we believe that an exaggerated immunological response to the vaccination is a likely cause for this case of CRD. Although, to our knowledge, RDD occurring post-vaccination has not been described previously, there has been a case of exaggerated antibody response in a child with RDD following rubella vaccination. Our experience suggests that vaccine-induced immune stimulation may provide an alternate trigger for inducing CRD." Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Rosai-Dorfman syndrome, Skin lesion, Skin plaque, Tenderness, Tuberculin test negative
Clinical narrative: Initial report was received on 03 October 2011 from scientific literature. Verbatim from the report: "A 68-year-old woman was referred for a 2-year history of an enlarging lesion on the right arm that developed several days after administration of the PNEUMOVAX 23 vaccine. She was healthy with no fever, malaise, or weight loss. The lesion began as a tender erythematous papule at the site of vaccination and increased in size with development of additional sites of involvement. Bacterial and fungal cultures, tuberculin skin testing, blood interferon-gamma release assay for tuberculosis, blastomycosis and coccidiomycosis serologies, cryptococcal antigen, and histoplasmosis urine antigen testing were all negative. Treatment with rifampin, azithromycin, and moxifloxican was initiated for presumed atypical mycobacterial infection without effect. Physical examination revealed a large (20 by 20 cm) erythematous plaque, with multiple hyperkeratotic papulonodules, involving the right arm (Fig 1). On the opposite arm, forearms, thighs, face and ears, there were erythematous macules coalescing into larger patches with overlying scale. Lymphadenopathy was absent. A biopsy specimen of the right arm revealed a mixed dermal infiltrate of foamy histiocytes, plasma cells, lymphocytes, neutrophils, and large pale histiocytes with feathery borders demonstrating emperipolesis (Fig 2, A). The large histiocytes were S-100 positive (Fig 2), B and CD1a negative. There was no evidence of microorganisms on acid-fast bacilli, Gram, and periodic acid Schiff stained sections. Previous biopsy specimens from multiple smaller lesions demonstrated similar findings. No lymphadenopathy was noted on a computed tomographic (CT) scan of the abdomen, chest, and pelvis. Over the course of 3 years under our care, the patient has shown partial improvement with multiple therapies, including topical, intralesional, and systemic corticosteroids; dapsone; isotretinoin; and liquid nitrogen cryotherapy." "In summary, our patient developed CRD after pneumococcal vaccination. As the eruption was temporally related and initially localized to the site of injection, we believe that an exaggerated immunological response to the vaccination is a likely cause for this case of CRD. Although, to our knowledge, RDD occurring post-vaccination has not been described previously, there has been a case of exaggerated antibody response in a child with RDD following rubella vaccination. Our experience suggests that vaccine-induced immune stimulation may provide an alternate trigger for inducing CRD." Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Urine analysis normal, Vaccination site erythema, Vaccination site pain, Vaccination site papule
Clinical narrative: Initial report was received on 03 October 2011 from scientific literature. Verbatim from the report: "A 68-year-old woman was referred for a 2-year history of an enlarging lesion on the right arm that developed several days after administration of the PNEUMOVAX 23 vaccine. She was healthy with no fever, malaise, or weight loss. The lesion began as a tender erythematous papule at the site of vaccination and increased in size with development of additional sites of involvement. Bacterial and fungal cultures, tuberculin skin testing, blood interferon-gamma release assay for tuberculosis, blastomycosis and coccidiomycosis serologies, cryptococcal antigen, and histoplasmosis urine antigen testing were all negative. Treatment with rifampin, azithromycin, and moxifloxican was initiated for presumed atypical mycobacterial infection without effect. Physical examination revealed a large (20 by 20 cm) erythematous plaque, with multiple hyperkeratotic papulonodules, involving the right arm (Fig 1). On the opposite arm, forearms, thighs, face and ears, there were erythematous macules coalescing into larger patches with overlying scale. Lymphadenopathy was absent. A biopsy specimen of the right arm revealed a mixed dermal infiltrate of foamy histiocytes, plasma cells, lymphocytes, neutrophils, and large pale histiocytes with feathery borders demonstrating emperipolesis (Fig 2, A). The large histiocytes were S-100 positive (Fig 2), B and CD1a negative. There was no evidence of microorganisms on acid-fast bacilli, Gram, and periodic acid Schiff stained sections. Previous biopsy specimens from multiple smaller lesions demonstrated similar findings. No lymphadenopathy was noted on a computed tomographic (CT) scan of the abdomen, chest, and pelvis. Over the course of 3 years under our care, the patient has shown partial improvement with multiple therapies, including topical, intralesional, and systemic corticosteroids; dapsone; isotretinoin; and liquid nitrogen cryotherapy." "In summary, our patient developed CRD after pneumococcal vaccination. As the eruption was temporally related and initially localized to the site of injection, we believe that an exaggerated immunological response to the vaccination is a likely cause for this case of CRD. Although, to our knowledge, RDD occurring post-vaccination has not been described previously, there has been a case of exaggerated antibody response in a child with RDD following rubella vaccination. Our experience suggests that vaccine-induced immune stimulation may provide an alternate trigger for inducing CRD." Documents held by sender: none.
Age: 1.32
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Convulsion, Febrile convulsion, Pyrexia, Vomiting, White blood cell count normal
Clinical narrative: Seizures and fever and vomiting; then 11 hours later Febrile seizure
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Base excess, Chest X-ray normal, Dysphonia, Throat tightness
Clinical narrative: Pt rec'd flu vaccine (see attached copy of lot etc) then 2 hrs later started with hoarse voice; throat tightness.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Ear pain, Fatigue, Headache, Injection site pain
Clinical narrative: Site of injection painful, itching and pain radiating up the neck area. As day progressed, extreme fatigue, head ache and symptoms of upper respiratory infection. Chest heaviness, ears aching, nasal discharge, and low grade fever.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pruritus, Neck pain, Pyrexia, Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: Site of injection painful, itching and pain radiating up the neck area. As day progressed, extreme fatigue, head ache and symptoms of upper respiratory infection. Chest heaviness, ears aching, nasal discharge, and low grade fever.
Age: 91.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site reaction, Muscle swelling, Myalgia
Clinical narrative: Left Deltiod tender, red, raised 5cm diameter.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Fatigue, Hyperhidrosis, Myalgia
Clinical narrative: Muscle aches, 100 temp, sweating with chill, fatigue
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Immobile, Pruritus, Swelling, Tenderness
Clinical narrative: Immobility, swelling, redness, itching, extreme sensivity to the touch
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Ocular hyperaemia, Oropharyngeal pain, Palpitations, Paraesthesia oral
Clinical narrative: Redness of eyes, heart racing, itching, tingling around mouth, sore throat, general poor feeling.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Redness of eyes, heart racing, itching, tingling around mouth, sore throat, general poor feeling.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Malaise, Syncope
Clinical narrative: Stomach pain for several hours then diarrhea.  Then vomiting.  Fainted on the bathroom floor and was found by my husband.  More diarrhea and vomiting.  Now just a headache.  Lost 7 pounds in one night due to diarrhea and vomiting.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting, Weight decreased
Clinical narrative: Stomach pain for several hours then diarrhea.  Then vomiting.  Fainted on the bathroom floor and was found by my husband.  More diarrhea and vomiting.  Now just a headache.  Lost 7 pounds in one night due to diarrhea and vomiting.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Chills, Pyrexia, Tremor, Vomiting
Clinical narrative: Had uncontrollable violent shaking for about an hour, then fever and chills all night and the next day with vomiting. Missed 2 days of work.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dry eye, Eye pruritus, Eye swelling, Eyelid oedema
Clinical narrative: "Received IM flu shot approximately 1500 on October 5, 2011. Beginning approximately 2 hours my left arm was too sore for me to raise over my head and later began to develop a little cough (more like needing to clear my throat), became tachycardic, eyes began to feel dry, itching and swelling to lids and inner eye began. When I got home I really thought I was developing a cold so I took some Nyquil and went to bed early. The next morning woke up with puffy eyelids and inner eye, tachycardia and other symptoms had resolved. The puffy eyelids and inner eye resolved by mid morning on October 6, 2011."
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Nasopharyngitis, Pain in extremity, Tachycardia, Throat irritation
Clinical narrative: "Received IM flu shot approximately 1500 on October 5, 2011. Beginning approximately 2 hours my left arm was too sore for me to raise over my head and later began to develop a little cough (more like needing to clear my throat), became tachycardic, eyes began to feel dry, itching and swelling to lids and inner eye began. When I got home I really thought I was developing a cold so I took some Nyquil and went to bed early. The next morning woke up with puffy eyelids and inner eye, tachycardia and other symptoms had resolved. The puffy eyelids and inner eye resolved by mid morning on October 6, 2011."
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Chest pain, Dizziness postural, Dyspnoea, Headache, Nausea
Clinical narrative: Symptoms began at approx. 8pm with a severe headache. 2 hours later, mouth, tongue, throat very swollen. Unable to take deep breaths, wheezing and very bad chest pain. Dizziness while standing and nausea. Fever of 102.2. Very difficult to breathe, called nurse line and was instructed to go immediately to emergency. Was given an IV and administered Benadryl and Toradol. Discharged from ER at approx 2am. Arrived at 11pm.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Oedema mouth, Pharyngeal oedema, Pyrexia, Swollen tongue, Wheezing
Clinical narrative: Symptoms began at approx. 8pm with a severe headache. 2 hours later, mouth, tongue, throat very swollen. Unable to take deep breaths, wheezing and very bad chest pain. Dizziness while standing and nausea. Fever of 102.2. Very difficult to breathe, called nurse line and was instructed to go immediately to emergency. Was given an IV and administered Benadryl and Toradol. Discharged from ER at approx 2am. Arrived at 11pm.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Client called facility on 10/10/2011 stating complaints of left arm sore and painful since shot was given.  Has pain when lifting arm up, however pain is not worsening at this time.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: Injection stinging 5-10 sec. afterwards. L arm sore later in day 10/11/11. When got home and took shower L arm more sore and swollen below injection site. 10/12 remains very sore and today swelling aprox egg size distal to injection site. also has bad headache today. Started aprox 20:15 on 10/11/11 and continues.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Sharp pain, unable to move in certain ways, painful at night.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site reaction, Myalgia, Neck pain
Clinical narrative: At time of injection pain (right arm) at injection site, up through the neck and down to the hand.  I am still having pain in the upper arm muscle.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: At time of injection pain (right arm) at injection site, up through the neck and down to the hand.  I am still having pain in the upper arm muscle.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Exostosis, Inflammation, Pain, X-ray abnormal
Clinical narrative: Patient received INLFUENZA injection in her left arm. She is stating she has had continued pain since she received injection.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised
Clinical narrative: Positive pruritus (general) persists without rash as of this report 10/12/11. Tx ZYRTEC - results unk.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: Rapid pulse - 129 bpm. Shortness of breath.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Two hours after shots developed hives on back, hips, stomach & shoulders. Accompanied by itching. Mom adm. 2 doses of homeopathic remedy and sx disappeared.
Age: 46.0
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, Eye irrigation
Clinical narrative: Patient was inadvertently sprayed with FLUMIST on (R) side of face and possibly (R) eye when student was attempting to deliver intranasal mist in (R) nostril. Eye was immediately flushed with eye rinse by RN. No swelling or redness noted before or after eye rinsing. Both nostrils effectively sprayed with FLUMIST by RN. No irritation of eye when client left clinic around 10AM.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Redness cover 4-5 inches around. No problem in the past. Patient is getting better.