chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: FLUX, HPV4, MNQ
Symptoms: Pain in extremity, Urine analysis, Wheezing, X-ray
Clinical narrative: Headaches all the time, dizziness, nausea, shortness of breath, wheezing, joint pains unusual tiredness, weakness, leg pain, generally feeling unwell and being sick all the time, stomach pains, depression, anxiety, the shot has caused me to fall (reported at the doctors that I fell and twisted my knee, this was after the first shot. I was getting up off the couch and I felt horrible joint pain in my knee, it made me fall because it hurt so bad, and also miss alot of school at the time, its really hard for me to work now.  I have pains all over and Drs still dont know why. My mom told me last night that her co workers friend has fibromyalgia from the shot and maybe that is what I have because of the shot.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: Large amounts of green diarrhea ongoing for about a week.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pain
Clinical narrative: Started feeling aching evening of 1/22, woke up with sever aches and fever at 4:30 am 1/23. Fever continued to rise and fall all day (highest temp 100.9), accompanied by muscle aches and pain, swelling and redness at injection site. Pain from muscle aches diminished on 1/24, fever continued off & on most of the day but still painful, red and very swollen at injection site.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Started feeling aching evening of 1/22, woke up with sever aches and fever at 4:30 am 1/23. Fever continued to rise and fall all day (highest temp 100.9), accompanied by muscle aches and pain, swelling and redness at injection site. Pain from muscle aches diminished on 1/24, fever continued off & on most of the day but still painful, red and very swollen at injection site.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Got the flu shot on 01/10/2013 and for the first few days I thought the pain at injection site was normal.  Well, here it is 2 weeks later and I am still having really bad pain and stiffness at injection site. It really hurts to take a shirt off & on and hurts to raise arm, lift it and move it around...  WHY after two weeks the injection site of the Flu Vaccine still very, very sore??
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: 8 inch x 4 inch red, indurated, mildly pruritic area surrounding injection site. Appeared 24 hrs. after injection.
Age: 0.4
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 months old patient who on 05-JAN-2009 was vaccinated with dose 2 RECOMBIVAX HB (adult dose) (lot # and route not provided). No other co-suspects were reported. No concomitant medications were reported. The nurse stated that the patient did not had adverse symptoms. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Induration, Injection site pruritus, Injection site swelling
Clinical narrative: 123 onset of itching/swelling of site of various injection. 8 cm x 8 cm erythema with smaller area of induration.
Age: 1.46
Sex: M
Vaccine: DTAP, MMR
Symptoms: Kawasaki's disease, Lymphadenopathy, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Swollen anterior lymph nodes & glands to neck, red raised & flat rash/bumps to entire upper body. Started on trunk & back, then cheeks & eats, then arms. Fever & 101 degrees F for 5 days. Fever started 8 days after injection. Rash appeared 10/11 days after injection.
Age: 1.33
Sex: M
Vaccine: DTAP, FLU3, MMR
Symptoms: Injection site haematoma, Injection site nodule
Clinical narrative: Accompanied by Dad today (1-22-13) for (L) thigh knot onset since 1-15-13 after vaccination when home, has not worsen since onset, denies fever / redness / bleeding / drainage / irritability / change in activities. Monitor if worsen to f/u / ER. Initial eval today from sxs onset - f/u with mom on phone on 1-24-13 - improving. 1 cm superficial lesion - round - palpable. Superficial hematoma from injection site with the recommendation to massage area and cool compress for 20-30 min. period every 4-6 hour as needed. Observe for any redness, soft tissue swelling, worsen pain with irritability and/or changes in activities / appetite to call clinic and/or ER A.S.A.P. Counseled.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Soreness of arm at injection site. Few days after shot. Going to neurologist - got cortisone shot & using heat.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age who on 21-JAN-2013 was vaccinated subcutaneously with lot # (672476/ 1605AA exp date: 13-JAN-2013), 0.65 ml live ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. The nurse stated that the patient did not had any adverse effects. This is one of several reports from the same source. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Redness, and inflammation of left arm.
Age: 3.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness, and inflammation of left arm.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender who on 21-JAN-2013 was vaccinated subcutaneously with lot # (672476/1605AA exp date: 13-JAN-2013), 0.65 ml live ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. The nurse stated that the patient did not had any adverse effects. This is one of several  reports from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Approx 1 day after AFLURIA and PNEUMOVAX dose, pt c/o swelling, redness, pain on injection site. Redirected pt to MD if not resolved in 3-5 days. Pt went to ER on 1/21 (3 days later) and was diagnosed cellulitis.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Hypoaesthesia, Induration, Injection site swelling, Oedema peripheral
Clinical narrative: Received tdap (L) arm 1-18-13 next day arm swelled reported back 1/23/13 arm very painful, hard & swollen woke up with tingling, numbness sensation in (L) hand. Taking MOTRIN for pain. 1-24-13 (L) arm deltoid/deltoid 3" bigger than (R) 12x10 cm hardened area 7 x 7 c, erythematous still sore.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Received tdap (L) arm 1-18-13 next day arm swelled reported back 1/23/13 arm very painful, hard & swollen woke up with tingling, numbness sensation in (L) hand. Taking MOTRIN for pain. 1-24-13 (L) arm deltoid/deltoid 3" bigger than (R) 12x10 cm hardened area 7 x 7 c, erythematous still sore.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 years old female patient with hypertension, hypercholesterolemia and sulfa drugs allergy. On 16-JAN-2013, the patient was administered a 0.65 ml dose live ZOSTAVAX (subcutaneous injection) (lot# not reported). No other co-suspects were reported. Concomitant medications included lovastatin, EVISTA, zolpidem tartrate, diltiazem hydrochloride and hydrochlorothiazide (manufacturer unknown). Immediately after vaccination the patient developed redness at injection site. On the second day after the vaccination the redness became warm, itchy and a non-vesicular rash developed with discomfort. The patient still has a very light rash as of 22-JAN-2013, although she stated she is not in as much discomfort as she had been. The patient was not treated. The relatedness of the event with live ZOSTAVAX was not provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 years old female patient with hypertension, hypercholesterolemia and sulfa drugs allergy. On 16-JAN-2013, the patient was administered a 0.65 ml dose live ZOSTAVAX (subcutaneous injection) (lot# not reported). No other co-suspects were reported. Concomitant medications included lovastatin, EVISTA, zolpidem tartrate, diltiazem hydrochloride and hydrochlorothiazide (manufacturer unknown). Immediately after vaccination the patient developed redness at injection site. On the second day after the vaccination the redness became warm, itchy and a non-vesicular rash developed with discomfort. The patient still has a very light rash as of 22-JAN-2013, although she stated she is not in as much discomfort as she had been. The patient was not treated. The relatedness of the event with live ZOSTAVAX was not provided. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: ZOSTAVAX administered SQ to the left upper arm on 1/22/13. Pt noted tenderness and redness to left arm injection site on 1/23/13. Pt states redness, puffiness, and tenderness worsened. Pt to clinic for eval of site on 1/24/13. Pt diagnosed with cellulitis of injection site and prescribed KEFLEX 500mg po BID x10 days. Pt instructed to follow up after antibiotics for eval or if symptoms worsen.
Age: 1.56
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 8.0
Sex: M
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a father's and mother's consumer refers to a 8 years 6 month old male patient with autism, who on 05-OCT-2012, was vaccinated mistakenly with a dose of GARDASIL (dose, route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The reporters' consumer reported that the patient had an appointment with his pediatrician to receive the second series of Hepatitis A vaccine (manufacturer unspecified), however the pediatrician's office mistakenly administered the GARDASIL vaccine. No treatment information was reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Patient received VARIVAX IM instead of Sub-Q. No adverse reaction occurred.
Sex: F
Vaccine: MMR
Symptoms: Accidental exposure to product, Eye irritation
Clinical narrative: This spontaneous report as received from an registered nurse refers to a staff member of unknown age. The staff member administered a dose of MMR II (lot # H015829, Expired date: 24-AUG-2014, dose and route not reported) in the physician's office on 17-JAN-2013. The staff member experienced burning in her eye after an unspecified amount of MMR II splashed up into her eye from the syringe due to the movement of the patient's arm during administration of the vaccine of MMR II. The patient flushed eye with water. The staff member was having her eye evaluated by an unspecified physician. At the time of reporting, the outcome of the event was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Feeling abnormal, Influenza like illness, Pyrexia
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a 14 years old female patient. The patient was vaccinated intramuscularly with the first dose of 0.5 ml GARDASIL (lot not reported) on 15-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The patient experienced fever of 100 Fahrenheit, flu-like symptoms and missed 3 days of work after receiving the first dose of GARDASIL. No treatment information was reported. The patient stated that it was the worst she had ever felt. These symptoms occurred a day later after GARDASIL vaccination and recovered within 3 days. The relatedness for the events was unknown for GARDASIL. Additional information is not expected.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Myelitis transverse
Clinical narrative: Transverse myelitis per staff at Dr.'s office at Hospital.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Acute disseminated encephalomyelitis, Asthenia, Blood creatine phosphokinase increased, CSF test abnormal, Confusional state
Clinical narrative: Transverse myelitis per staff at Dr.'s office at Hospital.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal stiffness, Myalgia, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Pyrexia
Clinical narrative: Transverse myelitis per staff at Dr.'s office at Hospital.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Urinary retention
Clinical narrative: Transverse myelitis per staff at Dr.'s office at Hospital.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Pt had ZOSTAVAX vaccine to (L) upper arm 1/12/13. Returned to clinic 1/16/13 with approx 6 x 6 inch area redness, tenderness, itching. No fever. No other rash or complaint.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Tenderness
Clinical narrative: Pt had ZOSTAVAX vaccine to (L) upper arm 1/12/13. Returned to clinic 1/16/13 with approx 6 x 6 inch area redness, tenderness, itching. No fever. No other rash or complaint.
Age: 0.47
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Condition aggravated, Fatigue, Irritability, Medication error, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 months old male patient. The patient was vaccinated with GARDASIL on 14-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The infant was to have received an antibiotic injection (name of antibiotic was unspecified). On 14-JAN-2013 the patient did not receive the antibiotic injection. No adverse event reported. No product confusion discovered, just medication error. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Age: 0.47
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 months old male patient. The patient was vaccinated with GARDASIL on 14-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The infant was to have received an antibiotic injection (name of antibiotic was unspecified). On 14-JAN-2013 the patient did not receive the antibiotic injection. No adverse event reported. No product confusion discovered, just medication error. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Age: 0.47
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Accidental exposure to product, Blood culture, Condition aggravated, Culture urine, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 months old male patient. The patient was vaccinated with GARDASIL on 14-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The infant was to have received an antibiotic injection (name of antibiotic was unspecified). On 14-JAN-2013 the patient did not receive the antibiotic injection. No adverse event reported. No product confusion discovered, just medication error. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Age: 0.47
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 months old male patient. The patient was vaccinated with GARDASIL on 14-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The infant was to have received an antibiotic injection (name of antibiotic was unspecified). On 14-JAN-2013 the patient did not receive the antibiotic injection. No adverse event reported. No product confusion discovered, just medication error. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 8 weeks old female patient with no pertinent medical history and drug reactions/allergies. On 20-DEC-2012 the patient was vaccinated with 2 millilitre (ml) ROTATEQ, oral (lot H010322, expiration date November 2013) orally. No concomitant medications were reported. On 21-DEC-2012 patient developed diarrhea. The patient did not require medical attention and the diarrhea resolved on an unknown date in January 2013 (reported as after two and one half weeks). No laboratory diagnostic tests were performed. Medical attention was sought via office visit. Additional information has been requested.
Age: 0.37
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Blood culture, CSF test, Computerised tomogram, Culture urine, Drug screen
Clinical narrative: Frequent episodes of unresponsiveness while awake. Stiffening, vomiting, arching of back, jerking occurred twice, one at ER. Given ATIVAN. First occurred on 1/16/13 around 10:30 AM.
Age: 0.37
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Dyskinesia, Electroencephalogram, Full blood count, Metabolic function test, Musculoskeletal stiffness
Clinical narrative: Frequent episodes of unresponsiveness while awake. Stiffening, vomiting, arching of back, jerking occurred twice, one at ER. Given ATIVAN. First occurred on 1/16/13 around 10:30 AM.
Age: 0.37
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Nuclear magnetic resonance imaging, Opisthotonus, Unresponsive to stimuli, Urine analysis, Urodynamics measurement
Clinical narrative: Frequent episodes of unresponsiveness while awake. Stiffening, vomiting, arching of back, jerking occurred twice, one at ER. Given ATIVAN. First occurred on 1/16/13 around 10:30 AM.
Age: 0.37
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Frequent episodes of unresponsiveness while awake. Stiffening, vomiting, arching of back, jerking occurred twice, one at ER. Given ATIVAN. First occurred on 1/16/13 around 10:30 AM.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Eye infection, Headache, Oropharyngeal pain, Pain
Clinical narrative: Eye infection symptoms in both eyes. Body aches. Sore throat. Headache.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Dry skin, Feeling abnormal, Flushing, Productive cough
Clinical narrative: Given flu and pneumonia immunization at 11:50 AM and as soon as reached car at 11:55 felt "funny and flushed". Laid pt down temp 99, BP 140/94, pulse 92. Skin dry and occ loose cough. States he "has a little bug in his chest this morning". At 12:05 feeling better, BP 148/94, temp 98.4. 12:10 AM Walked to car, wife driving, to take to Dr. or ER if worse.  12/4/12. Saw Dr this AM, chilled most of night, sleeping now. 12/11/12 Feeling better but felt "bad" for a few days.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Rash and extreme itching on upper torso. Several trips to clinic; perscribed neosporin, Benadryl, prednisone and loratadine.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Pruritus, Swelling
Clinical narrative: Rash and extreme itching on upper torso. Several trips to clinic; perscribed neosporin, Benadryl, prednisone and loratadine.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: On waking, he experienced pain in left arm and shoulder.  After a month still has some numbness and tingling in left arm and hand.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: This spontaneous report was received from a 65 years old female patient with penicillin allergy. The patient was vaccinated with ZOSTAVAX on an unspecified date for shingles vaccination. Lot # and administration route were unspecified. Concomitant medications included PROMETRIUM, ELESTRIN and LIPITOR. On an unknown date the patient was administered ZOSTAVAX and she developed a small saucer sized red, hot, bumpy, itchy spot near the injection site. No treatment was given. Outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Presyncope
Clinical narrative: Pt became lightheaded & came close to passing out. 911 was called pt did not lose consciousness.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling face
Clinical narrative: This spontaneous report as received from a 79 years old female consumer refers to herself with no pertinent history and no drug reactions or allergies. On 09-JAN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) for prevention of shingles. Concomitant medications included lisinopril, JANUVIA and meclizine. On 09-JAN-2012 after receiving ZOSTAVAX, the patient's face became swollen and she developed a rash. The rash has persisted since the date of administration of ZOSTAVAX. Treatment with BENADRYL was given for the events. No lab diagnostic studies were performed. The patient sought unspecified medical attention. The outcome of the events was reported as not recovered. The relatedness for the events was unknown for the vaccination. Additional information has been requested.
Sex: U
Vaccine: HPV4, MMR, MMRV, VARCEL
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. It was reported that possibly improperly stored GARDASIL, MMR II, PROQUAD and VARIVAX (Merck) might have been administered to the unknown number of patients since 16-DEC-2012 to 14-JAN-2013. Lot numbers of all therapies were not provided. No concomitant medications were reported. No adverse event reported. It was unspecified if the patients had sought medical attention. Additional information is not expected.
Age: 0.5
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a 6 months old patient. On 07-JAN-2013 (yesterday), the patient was vaccinated with a dose of GARDASIL (lot number, expiry date, dose and route unspecified) instead of HIB VACCINE (manufacturer unspecified). No product confusion was discovered, just a medication error. The pharmacist did not know if the patient received HIB VACCINE (manufacturer unspecified) on 07-JAN-2013 (yesterday). No concomitant medications were reported. No adverse event was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer concerning her female friend of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, after receiving the vaccination, the patient experienced shingles. She sought medical attention (saw the health care professional) and she was treated with OXYCONTIN for pain. The outcome of the event was unknown. The relatedness for the event was unknown for ZOSTAVAX. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt received vaccine on 01-21-13 around 4 pm. The following morning injection site noted to be red and swollen. Area was still swollen about 7 cm in diameter red, warm and painful to touch on 01.24.13. Mom brought pt into our office.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a patient's friend refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX. No route of administration, dosage information, lot number or expiration date was reported. No other co-suspects or concomitant medications were reported. The reporter stated that her friend who received ZOSTAVAX still developed a mild case of shingles. The outcome of the event was unknown. No further information regarding the adverse event was reported. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 20 years old female patient. The patient was vaccinated with a dose of expired MMR II (exp date: 11-AUG-2012, lot #, dose, route were unspecified) on 22-JAN-2013. No adverse effect reported. Outcome of the events were unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticaria 45 minutes after MMR & Varicella given.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse referred to a patient of unknown age. Nurse reported that an unspecified patient received the first dose of GARDASIL (lot #, dose/frequency, route were unspecified) in January 2011, "2 years ago" and was now (22-JAN-2013) in office to receive the second dose (lot #, dose/frequency, route were unspecified). The outcome was unknown. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse refers to a 87 years old female patient with atrial fibrillation, joint pain, osteoarthritis and MACROBID allergy. The patient was vaccinated with live ZOSTAVAX on 03-JUN-2008 at a since closed pharmacy. No other co-suspects were reported. Concomitant medications included digoxin, metoprolol, warfarin, CELEBREX, fish oil and vitamin D (unspecified). On an unknown date the patient experienced severs case of shingles on the buttocks and in the groin and presented at the physician's office on 16-JAN-2013. VALTREX was given as treatment. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Epistaxis
Clinical narrative: On 1/16/13 pt received flu shot. Approximately 1.5 hrs post-administration, pt experienced severe nosebleed as reported by his mother. The duration of nosebleed is unknown. Pt has no history of nosebleeds. Pt did not require medical attention.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site joint swelling, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: Swelling of shoulder and glands in left arm. High fever for 3 days. Headache & nausea for over seven days.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning two twins patients (gender and age unknown). On unknown date, the patients was vaccinated with two doses of VARIVAX (Merck) (lot number not provided). No other co-suspects were reported. No concomitant medications were reported. It was reported that their county was experienced an out break of chickenpox. The nurse stated that this county had a very high right of parents who opt-out of vaccines. At the time of the report, the outcome of chickenpox was unknown. The relatedness for chickenpox was unknown for VARIVAX (Merck). This is one of the several reports of the same source. Follow up information has been received from the nurse concerning one of the two twins who is a 13 years old male patient. On an unknown dates, the patient was vaccinated with 2 doses of VARIVAX (Merck). On 31-OCT-2012, the patient experienced chickenpox. The patient had recovered from chickenpox. Additional information is not expected.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Headache
Clinical narrative: Burning sensation to half of face, nose & lip included & slight headache.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient presents with a red, itchy, painful area near injection site. She noticed it at the time of injection & took BENADRYL & applied cortisone cream.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Tdap administered 12-28-12, 7 days later (L) upper arm red, swollen, tender to touch, redness and warmth spreading to (L) upper inner arm. Temp 99.4 (O).
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Tdap administered 12-28-12, 7 days later (L) upper arm swollen, tender to touch, redness and warmth spreading to (L) upper inner arm.
Age: 44.0
Sex: F
Vaccine: FLUN3
Symptoms: Face oedema, Pyrexia, Sinus congestion
Clinical narrative: Client has sx of fever, sinus congestion, & facial edema, (L) side of face. She states congestion started almost immediately after receiving FLUMIST. She states that she has been seen by her dentist, but sx were not related to dental problems. She has been referred to PMD.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Asthenia, Blood pressure decreased, Hyperhidrosis, Pallor, Radial pulse abnormal
Clinical narrative: Had 4 immunization today approximately 10 minutes after injections patient very pale, weak, sweating in waiting rm had good breakfast at home before shots - BP decreased 86/48 - No radial pulse - carotid pulse 86- took too long for patient to recover-MD advised go to ER/EMS.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Lingering pain in deltoid after 5 days.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse concerning a patient of unknown age and gender who on 17-JAN-2013 was vaccinated with dose 3 of GARDASIL (Lot number H016960, Exp 02-DEC-2013) that was exposed to minus 10 degrees C for 4 hours. No adverse symptoms reported. Additional information has been requested.
Age: 1.14
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Lethargy, Nausea, Pallor, Vomiting
Clinical narrative: Severe nausea and vomiting 2-3 hr after vaccine administration. Sent to ER for supportive care. Found to be pale, lethargic, rehydrated. Diarrhea next day.
Age: 44.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Ear pruritus, Headache, Oropharyngeal pain, Sinus headache
Clinical narrative: Started with headache and tickle in throat. By the next day itch in ears, sore throat, cough, post nasal drip, sinus pain.
Age: 44.0
Sex: F
Vaccine: FLUN3
Symptoms: Throat irritation, Upper-airway cough syndrome
Clinical narrative: Started with headache and tickle in throat. By the next day itch in ears, sore throat, cough, post nasal drip, sinus pain.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: High fever, febrile seizure.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Amnesia, Aphagia, Arthralgia, Blood test
Clinical narrative: The day after vaccine 4/6/2012, patient was more hyper, less attentive, less affect, less eye contact, and some strange facial expressions. Low temp of 99. All within normal side effects for vaccine assuming they were temporary and self limiting; no concern at this point of reaction. Upon waking, patient was lethargic, irritable, flushed. Temperature reading at 8:00 was 103. Patient had never experienced a fever higher than 102 in his life, or lethargy, despite having several viruses in his young life. Patient was taken to doctor this day, thought to be virus, however the next morning awoke perfectly well. This is when the immune activation is thought to have begun. On 4/29/2012 mild leg pain and fatigue; extremely unusual for patient. This is when the Encephalopathy is thought to have begun.  4/30/2012 Awoke at 5:30 screaming, afraid, nightsweat. Irritable, flushed, lethargic. Similar to previous event with 103.5 fever this time. This time however, he looked, felt, acted, seriously ill. Was unable to eat, would not drink, scared, skin hurt. This is when suspected Encephalomyelitis began. On the way to the doctor's office, his pupils were as large as his iris, shivering, aching knees, leg muscles, breathing was labored. Dr. that he saw observed that he was very ill and did bloodwork for mono, EBV, strep. All turned out to be negative. He woke up "well" the next morning. Another episode on 5/2/2012 in which he had headache, small bumpy rash on his ears, arms, and legs, completely lethargic, diarrhea. This is the day that the neurological symptoms became more noticable. For the next 7-10 days, patient loss cognitive abilities, memory loss, muscle pain, sensory sensations, nightmares / possible febrile seizures, hearing, vision changes, urination accidents, loss of coordination, unable to pronounce words, unable to follow directions, unable to express himself the way that he had always been able to so well.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Chills, Cognitive disorder, Coordination abnormal, Decreased eye contact, Diarrhoea
Clinical narrative: The day after vaccine 4/6/2012, patient was more hyper, less attentive, less affect, less eye contact, and some strange facial expressions. Low temp of 99. All within normal side effects for vaccine assuming they were temporary and self limiting; no concern at this point of reaction. Upon waking, patient was lethargic, irritable, flushed. Temperature reading at 8:00 was 103. Patient had never experienced a fever higher than 102 in his life, or lethargy, despite having several viruses in his young life. Patient was taken to doctor this day, thought to be virus, however the next morning awoke perfectly well. This is when the immune activation is thought to have begun. On 4/29/2012 mild leg pain and fatigue; extremely unusual for patient. This is when the Encephalopathy is thought to have begun.  4/30/2012 Awoke at 5:30 screaming, afraid, nightsweat. Irritable, flushed, lethargic. Similar to previous event with 103.5 fever this time. This time however, he looked, felt, acted, seriously ill. Was unable to eat, would not drink, scared, skin hurt. This is when suspected Encephalomyelitis began. On the way to the doctor's office, his pupils were as large as his iris, shivering, aching knees, leg muscles, breathing was labored. Dr. that he saw observed that he was very ill and did bloodwork for mono, EBV, strep. All turned out to be negative. He woke up "well" the next morning. Another episode on 5/2/2012 in which he had headache, small bumpy rash on his ears, arms, and legs, completely lethargic, diarrhea. This is the day that the neurological symptoms became more noticable. For the next 7-10 days, patient loss cognitive abilities, memory loss, muscle pain, sensory sensations, nightmares / possible febrile seizures, hearing, vision changes, urination accidents, loss of coordination, unable to pronounce words, unable to follow directions, unable to express himself the way that he had always been able to so well.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Disturbance in attention, Dyspnoea, Encephalomyelitis, Encephalopathy, Epstein-Barr virus test negative
Clinical narrative: The day after vaccine 4/6/2012, patient was more hyper, less attentive, less affect, less eye contact, and some strange facial expressions. Low temp of 99. All within normal side effects for vaccine assuming they were temporary and self limiting; no concern at this point of reaction. Upon waking, patient was lethargic, irritable, flushed. Temperature reading at 8:00 was 103. Patient had never experienced a fever higher than 102 in his life, or lethargy, despite having several viruses in his young life. Patient was taken to doctor this day, thought to be virus, however the next morning awoke perfectly well. This is when the immune activation is thought to have begun. On 4/29/2012 mild leg pain and fatigue; extremely unusual for patient. This is when the Encephalopathy is thought to have begun.  4/30/2012 Awoke at 5:30 screaming, afraid, nightsweat. Irritable, flushed, lethargic. Similar to previous event with 103.5 fever this time. This time however, he looked, felt, acted, seriously ill. Was unable to eat, would not drink, scared, skin hurt. This is when suspected Encephalomyelitis began. On the way to the doctor's office, his pupils were as large as his iris, shivering, aching knees, leg muscles, breathing was labored. Dr. that he saw observed that he was very ill and did bloodwork for mono, EBV, strep. All turned out to be negative. He woke up "well" the next morning. Another episode on 5/2/2012 in which he had headache, small bumpy rash on his ears, arms, and legs, completely lethargic, diarrhea. This is the day that the neurological symptoms became more noticable. For the next 7-10 days, patient loss cognitive abilities, memory loss, muscle pain, sensory sensations, nightmares / possible febrile seizures, hearing, vision changes, urination accidents, loss of coordination, unable to pronounce words, unable to follow directions, unable to express himself the way that he had always been able to so well.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Fatigue, Fear, Fluid intake reduced, Flushing, Headache
Clinical narrative: The day after vaccine 4/6/2012, patient was more hyper, less attentive, less affect, less eye contact, and some strange facial expressions. Low temp of 99. All within normal side effects for vaccine assuming they were temporary and self limiting; no concern at this point of reaction. Upon waking, patient was lethargic, irritable, flushed. Temperature reading at 8:00 was 103. Patient had never experienced a fever higher than 102 in his life, or lethargy, despite having several viruses in his young life. Patient was taken to doctor this day, thought to be virus, however the next morning awoke perfectly well. This is when the immune activation is thought to have begun. On 4/29/2012 mild leg pain and fatigue; extremely unusual for patient. This is when the Encephalopathy is thought to have begun.  4/30/2012 Awoke at 5:30 screaming, afraid, nightsweat. Irritable, flushed, lethargic. Similar to previous event with 103.5 fever this time. This time however, he looked, felt, acted, seriously ill. Was unable to eat, would not drink, scared, skin hurt. This is when suspected Encephalomyelitis began. On the way to the doctor's office, his pupils were as large as his iris, shivering, aching knees, leg muscles, breathing was labored. Dr. that he saw observed that he was very ill and did bloodwork for mono, EBV, strep. All turned out to be negative. He woke up "well" the next morning. Another episode on 5/2/2012 in which he had headache, small bumpy rash on his ears, arms, and legs, completely lethargic, diarrhea. This is the day that the neurological symptoms became more noticable. For the next 7-10 days, patient loss cognitive abilities, memory loss, muscle pain, sensory sensations, nightmares / possible febrile seizures, hearing, vision changes, urination accidents, loss of coordination, unable to pronounce words, unable to follow directions, unable to express himself the way that he had always been able to so well.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Hearing impaired, Irritability, Lethargy, Malaise, Mononucleosis heterophile test negative
Clinical narrative: The day after vaccine 4/6/2012, patient was more hyper, less attentive, less affect, less eye contact, and some strange facial expressions. Low temp of 99. All within normal side effects for vaccine assuming they were temporary and self limiting; no concern at this point of reaction. Upon waking, patient was lethargic, irritable, flushed. Temperature reading at 8:00 was 103. Patient had never experienced a fever higher than 102 in his life, or lethargy, despite having several viruses in his young life. Patient was taken to doctor this day, thought to be virus, however the next morning awoke perfectly well. This is when the immune activation is thought to have begun. On 4/29/2012 mild leg pain and fatigue; extremely unusual for patient. This is when the Encephalopathy is thought to have begun.  4/30/2012 Awoke at 5:30 screaming, afraid, nightsweat. Irritable, flushed, lethargic. Similar to previous event with 103.5 fever this time. This time however, he looked, felt, acted, seriously ill. Was unable to eat, would not drink, scared, skin hurt. This is when suspected Encephalomyelitis began. On the way to the doctor's office, his pupils were as large as his iris, shivering, aching knees, leg muscles, breathing was labored. Dr. that he saw observed that he was very ill and did bloodwork for mono, EBV, strep. All turned out to be negative. He woke up "well" the next morning. Another episode on 5/2/2012 in which he had headache, small bumpy rash on his ears, arms, and legs, completely lethargic, diarrhea. This is the day that the neurological symptoms became more noticable. For the next 7-10 days, patient loss cognitive abilities, memory loss, muscle pain, sensory sensations, nightmares / possible febrile seizures, hearing, vision changes, urination accidents, loss of coordination, unable to pronounce words, unable to follow directions, unable to express himself the way that he had always been able to so well.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Myalgia, Mydriasis, Neurological symptom, Night sweats, Nightmare
Clinical narrative: The day after vaccine 4/6/2012, patient was more hyper, less attentive, less affect, less eye contact, and some strange facial expressions. Low temp of 99. All within normal side effects for vaccine assuming they were temporary and self limiting; no concern at this point of reaction. Upon waking, patient was lethargic, irritable, flushed. Temperature reading at 8:00 was 103. Patient had never experienced a fever higher than 102 in his life, or lethargy, despite having several viruses in his young life. Patient was taken to doctor this day, thought to be virus, however the next morning awoke perfectly well. This is when the immune activation is thought to have begun. On 4/29/2012 mild leg pain and fatigue; extremely unusual for patient. This is when the Encephalopathy is thought to have begun.  4/30/2012 Awoke at 5:30 screaming, afraid, nightsweat. Irritable, flushed, lethargic. Similar to previous event with 103.5 fever this time. This time however, he looked, felt, acted, seriously ill. Was unable to eat, would not drink, scared, skin hurt. This is when suspected Encephalomyelitis began. On the way to the doctor's office, his pupils were as large as his iris, shivering, aching knees, leg muscles, breathing was labored. Dr. that he saw observed that he was very ill and did bloodwork for mono, EBV, strep. All turned out to be negative. He woke up "well" the next morning. Another episode on 5/2/2012 in which he had headache, small bumpy rash on his ears, arms, and legs, completely lethargic, diarrhea. This is the day that the neurological symptoms became more noticable. For the next 7-10 days, patient loss cognitive abilities, memory loss, muscle pain, sensory sensations, nightmares / possible febrile seizures, hearing, vision changes, urination accidents, loss of coordination, unable to pronounce words, unable to follow directions, unable to express himself the way that he had always been able to so well.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Pain in extremity, Pain of skin, Psychomotor hyperactivity, Pyrexia, Rash
Clinical narrative: The day after vaccine 4/6/2012, patient was more hyper, less attentive, less affect, less eye contact, and some strange facial expressions. Low temp of 99. All within normal side effects for vaccine assuming they were temporary and self limiting; no concern at this point of reaction. Upon waking, patient was lethargic, irritable, flushed. Temperature reading at 8:00 was 103. Patient had never experienced a fever higher than 102 in his life, or lethargy, despite having several viruses in his young life. Patient was taken to doctor this day, thought to be virus, however the next morning awoke perfectly well. This is when the immune activation is thought to have begun. On 4/29/2012 mild leg pain and fatigue; extremely unusual for patient. This is when the Encephalopathy is thought to have begun.  4/30/2012 Awoke at 5:30 screaming, afraid, nightsweat. Irritable, flushed, lethargic. Similar to previous event with 103.5 fever this time. This time however, he looked, felt, acted, seriously ill. Was unable to eat, would not drink, scared, skin hurt. This is when suspected Encephalomyelitis began. On the way to the doctor's office, his pupils were as large as his iris, shivering, aching knees, leg muscles, breathing was labored. Dr. that he saw observed that he was very ill and did bloodwork for mono, EBV, strep. All turned out to be negative. He woke up "well" the next morning. Another episode on 5/2/2012 in which he had headache, small bumpy rash on his ears, arms, and legs, completely lethargic, diarrhea. This is the day that the neurological symptoms became more noticable. For the next 7-10 days, patient loss cognitive abilities, memory loss, muscle pain, sensory sensations, nightmares / possible febrile seizures, hearing, vision changes, urination accidents, loss of coordination, unable to pronounce words, unable to follow directions, unable to express himself the way that he had always been able to so well.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Screaming, Sensory disturbance, Speech disorder, Streptococcus test negative, Urinary incontinence
Clinical narrative: The day after vaccine 4/6/2012, patient was more hyper, less attentive, less affect, less eye contact, and some strange facial expressions. Low temp of 99. All within normal side effects for vaccine assuming they were temporary and self limiting; no concern at this point of reaction. Upon waking, patient was lethargic, irritable, flushed. Temperature reading at 8:00 was 103. Patient had never experienced a fever higher than 102 in his life, or lethargy, despite having several viruses in his young life. Patient was taken to doctor this day, thought to be virus, however the next morning awoke perfectly well. This is when the immune activation is thought to have begun. On 4/29/2012 mild leg pain and fatigue; extremely unusual for patient. This is when the Encephalopathy is thought to have begun.  4/30/2012 Awoke at 5:30 screaming, afraid, nightsweat. Irritable, flushed, lethargic. Similar to previous event with 103.5 fever this time. This time however, he looked, felt, acted, seriously ill. Was unable to eat, would not drink, scared, skin hurt. This is when suspected Encephalomyelitis began. On the way to the doctor's office, his pupils were as large as his iris, shivering, aching knees, leg muscles, breathing was labored. Dr. that he saw observed that he was very ill and did bloodwork for mono, EBV, strep. All turned out to be negative. He woke up "well" the next morning. Another episode on 5/2/2012 in which he had headache, small bumpy rash on his ears, arms, and legs, completely lethargic, diarrhea. This is the day that the neurological symptoms became more noticable. For the next 7-10 days, patient loss cognitive abilities, memory loss, muscle pain, sensory sensations, nightmares / possible febrile seizures, hearing, vision changes, urination accidents, loss of coordination, unable to pronounce words, unable to follow directions, unable to express himself the way that he had always been able to so well.