chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: FLUN3
Symptoms: Dry eye, Eye irritation, Glomerular filtration rate normal, Headache, High density lipoprotein decreased
Clinical narrative: Patient reports he received his first FLUMIST vaccine in OCT 2009 while deployed. (Immunization records shows patient received IM flu vaccine in OCT 2009, but patient recalls lining up and getting the FLUMIST). Within hours of vaccine receipt, he developed rhinorrhea, cough, stuffy nose, upper airway congestion, headache (pressure-type pain above and behind eyes), sneezing, watery eyes, fever up to 100+ degrees F, chills, swollen glands in his neck and on the 2nd or 3rd day after vaccine receipt, he developed diarrhea (4-5 watery stools, no blood, no cramping, no N/V). He also reports muscle soreness in his chest and upper abdomen from coughing. He denies any facial swelling, redness of eyes, sore throat, sinus pressure or drainage, rashes, wheezing or dyspnea. Following his initial FLUMIST, patient was admitted to the hospital on bedrest for 2 days. He received IV fluids and he is not sure what other medications he received. (There are no encounters in the system addressing this admission). Although he was discharged from the hospital and RTD, patient reports his symptoms gradually improved over the next 2 weeks. Patient reports a similar reaction following his 2nd FLUMIST vaccine received on 17 OCT 2010. He was not admitted, but he was on bedrest at home x 1 week (48 hours quarters, work supervisor permitted him to stay home an additional 2 days, and then sick over week-end). Again, his symptoms gradually resolved after 2 weeks. He was instructed to take ALEVE and increase his fluid intake. Patient experienced similar symptoms within 24 hours of FLUMIST vaccine receipt again in SEP 2011, but less severe and not requiring time off from work or bed rest. This year, on 14 AUG, patient received the FLUMIST vaccine and developed similar symptoms (no diarrhea) which only lasted about 24-48 hours. However, on 15 AUG, patient was seen in the ER for irritated, red eyes and was diagnosed with severe Dry Eye Syndrome. (Patient reports he has had Dry Eye Syndrome since 2006 after PRK. He denies anything different about symptoms on 15 AUG, other than severity). Patient reports always feeling well on day of vaccinations, prior to vaccine receipt. He denies history of recent infection prior to vaccine receipt. With each reaction, the FLUMIST was the only vaccine received on that day, with no other vaccines received in the past 30 days. He does not recall any potential exposures prior to vaccine receipt. He denies allergies to medications, foods, latex and insect bites/bee stings. He denies a history of seasonal allergies.
Age: 43.0
Sex: M
Vaccine: FLUN3
Symptoms: Lacrimation increased, Low density lipoprotein normal, Lymphadenopathy, Myalgia, Nasal congestion
Clinical narrative: Patient reports he received his first FLUMIST vaccine in OCT 2009 while deployed. (Immunization records shows patient received IM flu vaccine in OCT 2009, but patient recalls lining up and getting the FLUMIST). Within hours of vaccine receipt, he developed rhinorrhea, cough, stuffy nose, upper airway congestion, headache (pressure-type pain above and behind eyes), sneezing, watery eyes, fever up to 100+ degrees F, chills, swollen glands in his neck and on the 2nd or 3rd day after vaccine receipt, he developed diarrhea (4-5 watery stools, no blood, no cramping, no N/V). He also reports muscle soreness in his chest and upper abdomen from coughing. He denies any facial swelling, redness of eyes, sore throat, sinus pressure or drainage, rashes, wheezing or dyspnea. Following his initial FLUMIST, patient was admitted to the hospital on bedrest for 2 days. He received IV fluids and he is not sure what other medications he received. (There are no encounters in the system addressing this admission). Although he was discharged from the hospital and RTD, patient reports his symptoms gradually improved over the next 2 weeks. Patient reports a similar reaction following his 2nd FLUMIST vaccine received on 17 OCT 2010. He was not admitted, but he was on bedrest at home x 1 week (48 hours quarters, work supervisor permitted him to stay home an additional 2 days, and then sick over week-end). Again, his symptoms gradually resolved after 2 weeks. He was instructed to take ALEVE and increase his fluid intake. Patient experienced similar symptoms within 24 hours of FLUMIST vaccine receipt again in SEP 2011, but less severe and not requiring time off from work or bed rest. This year, on 14 AUG, patient received the FLUMIST vaccine and developed similar symptoms (no diarrhea) which only lasted about 24-48 hours. However, on 15 AUG, patient was seen in the ER for irritated, red eyes and was diagnosed with severe Dry Eye Syndrome. (Patient reports he has had Dry Eye Syndrome since 2006 after PRK. He denies anything different about symptoms on 15 AUG, other than severity). Patient reports always feeling well on day of vaccinations, prior to vaccine receipt. He denies history of recent infection prior to vaccine receipt. With each reaction, the FLUMIST was the only vaccine received on that day, with no other vaccines received in the past 30 days. He does not recall any potential exposures prior to vaccine receipt. He denies allergies to medications, foods, latex and insect bites/bee stings. He denies a history of seasonal allergies.
Age: 43.0
Sex: M
Vaccine: FLUN3
Symptoms: Ocular hyperaemia, Protein total normal, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: Patient reports he received his first FLUMIST vaccine in OCT 2009 while deployed. (Immunization records shows patient received IM flu vaccine in OCT 2009, but patient recalls lining up and getting the FLUMIST). Within hours of vaccine receipt, he developed rhinorrhea, cough, stuffy nose, upper airway congestion, headache (pressure-type pain above and behind eyes), sneezing, watery eyes, fever up to 100+ degrees F, chills, swollen glands in his neck and on the 2nd or 3rd day after vaccine receipt, he developed diarrhea (4-5 watery stools, no blood, no cramping, no N/V). He also reports muscle soreness in his chest and upper abdomen from coughing. He denies any facial swelling, redness of eyes, sore throat, sinus pressure or drainage, rashes, wheezing or dyspnea. Following his initial FLUMIST, patient was admitted to the hospital on bedrest for 2 days. He received IV fluids and he is not sure what other medications he received. (There are no encounters in the system addressing this admission). Although he was discharged from the hospital and RTD, patient reports his symptoms gradually improved over the next 2 weeks. Patient reports a similar reaction following his 2nd FLUMIST vaccine received on 17 OCT 2010. He was not admitted, but he was on bedrest at home x 1 week (48 hours quarters, work supervisor permitted him to stay home an additional 2 days, and then sick over week-end). Again, his symptoms gradually resolved after 2 weeks. He was instructed to take ALEVE and increase his fluid intake. Patient experienced similar symptoms within 24 hours of FLUMIST vaccine receipt again in SEP 2011, but less severe and not requiring time off from work or bed rest. This year, on 14 AUG, patient received the FLUMIST vaccine and developed similar symptoms (no diarrhea) which only lasted about 24-48 hours. However, on 15 AUG, patient was seen in the ER for irritated, red eyes and was diagnosed with severe Dry Eye Syndrome. (Patient reports he has had Dry Eye Syndrome since 2006 after PRK. He denies anything different about symptoms on 15 AUG, other than severity). Patient reports always feeling well on day of vaccinations, prior to vaccine receipt. He denies history of recent infection prior to vaccine receipt. With each reaction, the FLUMIST was the only vaccine received on that day, with no other vaccines received in the past 30 days. He does not recall any potential exposures prior to vaccine receipt. He denies allergies to medications, foods, latex and insect bites/bee stings. He denies a history of seasonal allergies.
Age: 43.0
Sex: M
Vaccine: FLUN3
Symptoms: Total cholesterol/HDL ratio, Upper respiratory tract congestion, Very low density lipoprotein normal
Clinical narrative: Patient reports he received his first FLUMIST vaccine in OCT 2009 while deployed. (Immunization records shows patient received IM flu vaccine in OCT 2009, but patient recalls lining up and getting the FLUMIST). Within hours of vaccine receipt, he developed rhinorrhea, cough, stuffy nose, upper airway congestion, headache (pressure-type pain above and behind eyes), sneezing, watery eyes, fever up to 100+ degrees F, chills, swollen glands in his neck and on the 2nd or 3rd day after vaccine receipt, he developed diarrhea (4-5 watery stools, no blood, no cramping, no N/V). He also reports muscle soreness in his chest and upper abdomen from coughing. He denies any facial swelling, redness of eyes, sore throat, sinus pressure or drainage, rashes, wheezing or dyspnea. Following his initial FLUMIST, patient was admitted to the hospital on bedrest for 2 days. He received IV fluids and he is not sure what other medications he received. (There are no encounters in the system addressing this admission). Although he was discharged from the hospital and RTD, patient reports his symptoms gradually improved over the next 2 weeks. Patient reports a similar reaction following his 2nd FLUMIST vaccine received on 17 OCT 2010. He was not admitted, but he was on bedrest at home x 1 week (48 hours quarters, work supervisor permitted him to stay home an additional 2 days, and then sick over week-end). Again, his symptoms gradually resolved after 2 weeks. He was instructed to take ALEVE and increase his fluid intake. Patient experienced similar symptoms within 24 hours of FLUMIST vaccine receipt again in SEP 2011, but less severe and not requiring time off from work or bed rest. This year, on 14 AUG, patient received the FLUMIST vaccine and developed similar symptoms (no diarrhea) which only lasted about 24-48 hours. However, on 15 AUG, patient was seen in the ER for irritated, red eyes and was diagnosed with severe Dry Eye Syndrome. (Patient reports he has had Dry Eye Syndrome since 2006 after PRK. He denies anything different about symptoms on 15 AUG, other than severity). Patient reports always feeling well on day of vaccinations, prior to vaccine receipt. He denies history of recent infection prior to vaccine receipt. With each reaction, the FLUMIST was the only vaccine received on that day, with no other vaccines received in the past 30 days. He does not recall any potential exposures prior to vaccine receipt. He denies allergies to medications, foods, latex and insect bites/bee stings. He denies a history of seasonal allergies.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Feeling hot, Similar reaction on previous exposure to drug, Swelling
Clinical narrative: 10 by 10 cm redness, swelling warmth of deltoid Left. similar reaction with previous, but each vaccination size of swelling redness increases.
Age: 3.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Influenza virus test negative, Intensive care, Nasopharyngitis, Respiratory arrest
Clinical narrative: Respiratory arrest at home after 4 days of worsening cold symptoms. Driven by family auto to Medical Center and then transfered to PICU at another hospital.
Age: 3.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Convulsion, Death
Clinical narrative: Respiratory arrest at home after 4 days of worsening cold symptoms. Driven by family auto to Medical Center and then transfered to PICU at another hospital.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Heart rate increased, Paraesthesia
Clinical narrative: Patient had symtpoms of dizziness, racing heart rate, elevated BP, tingling in the legs.
Age: 75.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient too old to receive Flumist vaccination.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: PT REPORTED ON 9/25/2012 THAT HE HAD NERVE PAIN AND HAD SPOKEN TO 2 DRS WHO SAID IT WAS A RESULT OF THE ZOSTAVAX VACCINATION. BOTH DR'S SAID TO INFORM PHARMACY, WHO SHOULD REPORT SIDE EFFECT.
Age: 76.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was too old to receive vaccination.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Sensation of heaviness
Clinical narrative: Pain, numbness,heaviness and tingling in left arm.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Palpitations, Vomiting
Clinical narrative: Headache, chills, nausea, vomiting, heart racing.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in jaw, Palpitations
Clinical narrative: Employee stated she was taken to ER in ambulance, began to feel painin jaw started experiencing numbness to left side of face. She felt her heart was racing around 9 pm and called ambulance. She admitted having a history of PVC's 2004-2008. States no current health problems. She took Fluzone and to her understanding it has greater side effects than Flulaval which she took last year with no problems. The employee was given 2 days off to recouperate. I instructed her to f/u with her primary MD which had not been done at the time of this report.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Feeling hot, Injection site pain, Pruritus, Urticaria
Clinical narrative: Left arm became very hot, itchy and had a burning sensation. Numerous welts/hives formed on arm. Unknown how long it lasted, placed antibiotic/anti-itch salve on hives. Arm where injection was given was very sore for 4 days.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Atrial fibrillation
Clinical narrative: Pt alleges she was kept overnight at the hospital because of A fib.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Myalgia, Nausea
Clinical narrative: Nausea, diarrhea, chills, muscle aches.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Dizziness, Feeling hot, Injection site pain, Respiratory tract congestion
Clinical narrative: Soreness at site, "feels warm", light headed. Pt states symptoms lasted 4 days states she also had chest tightness and was congested.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Left arm edema, red, tender with movement.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile Seizure approximately 4-5 over course of 2 hours with accompanying fever.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Alopecia, Arthralgia, Blood glucose increased, Joint swelling, Oedema peripheral
Clinical narrative: Itching all over body, swollen painful joints, swollen hands and feet.  Large amount of Hair Loss.  Increased blood sugar.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus generalised
Clinical narrative: Itching all over body, swollen painful joints, swollen hands and feet.  Large amount of Hair Loss.  Increased blood sugar.
Age: 23.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Pallor, Skin warm
Clinical narrative: C/O of warmness, nausea, paleness, lightheaded - dizziness immediately after the injection was given. Donor assisted to the exam table and legs were elevated, ice pack applied to chest/abdomen w/resolution of all sx within 5 minutes. Stated, had not ate since 12:30 PM. Oral fluids provided and peanut crackers to eat.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest pain, Injection site pain, Lethargy, Musculoskeletal pain, Neck pain
Clinical narrative: Very painful injection site, arm, hand, neck, shoulders, chest, lasting several days. Lethargy as well. Requested VAERS report. Recovery about 3-4 days.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Very painful injection site, arm, hand, neck, shoulders, chest, lasting several days. Lethargy as well. Requested VAERS report. Recovery about 3-4 days.
Age: 1.16
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pruritus, Rash, Rash generalised, Viral rash
Clinical narrative: Had MMR, Varicella and DTaP on 9/10/12. On 9/18/12 Mom noticed a rash starting on back of neck which spread to whole body and became itchy over the next several days. Also ill from virus during same timeframe so viral exanthem vs rash from MMR or Varicella vaccine. 2 follow up exams required.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Redness and heat covering entire anterior, outer arm surface. No red streaks noted. Rec OTC BENADRYL 25mg TID and cool compresses per MD. She is to return if sx are prolonged or worsens.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Mobility decreased, Pain in extremity
Clinical narrative: Arm sore not easy to lift somewhat hot. Ice packs Ibuprofen.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Bump on injection site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Burning sensation, Pruritus, Rash erythematous
Clinical narrative: Red rash on arm and neck. Itch and burn. Patient received treatment w/ Valacyclovir.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Fever up to 104 only reducing slightly with fever reducers. Large red, painful and warm area to injection site.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Laceration, Suture insertion, Syncope
Clinical narrative: Pt. received Flu vaccine. Sat for 10 minutes and when she got up to leave she fell forward due to fainting, she had a small laceration to forehead. Dr. sutured wound.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Myalgia
Clinical narrative: Pt called & complained of severe muscle aches & numbness in her arm (3 days after administration). She could hardly move it. Was told to take ADVIL or ALEVE for it.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Headache, Oedema peripheral
Clinical narrative: Swollen arm - 48 hours to resolve. Headache - gone with in 26 hours. Cough - 48 hours to resolve. Tired - 48 hours to resolve. No prior adverse effects to vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction, red, warm to touch and swollen. Told pt. to take BENADRYL and IBU and ice.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Lymph node pain, Lymphadenopathy, Rash pustular, Scab
Clinical narrative: Patient developed several clustered pustules near his armpit (several inches away from injection site). They were red and drained fluid for a few days before scabbing over. He reported a swollen lymph node in his armpit that was painful.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Secretion discharge
Clinical narrative: Patient developed several clustered pustules near his armpit (several inches away from injection site). They were red and drained fluid for a few days before scabbing over. He reported a swollen lymph node in his armpit that was painful.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pruritus, Pain in extremity, Rash, Sleep disorder
Clinical narrative: Pt. had immediate itching at injection site by that evening rash appeared 1" diameter. Next morning, circular rash had grown to 2" diameter w/ hard not. Pt. had pain in arm that woke her up.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral
Clinical narrative: Pt reported area under armpit was swollen and raised the day after the shot. Reported got larger and larger and was filled with a fluid (jelly-like) substance. Went away by 3rd day.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Unresponsive to stimuli
Clinical narrative: Incident was reported to our office by patient's mother, it was not witnessed by anyone here in the clinic. On 9/19/20, pt. received flu vaccine, leaving the clinic around 1230. Shortly after leaving, pt's mother said pt told her she was not feeling well. They stopped for lunch and then ran some errands. About 130pm, pt again told her mother that she was not feeling well. Then, according to the mother, pt's head leaned to the right and her eyes closed. Mother said pt did not respond to mother's voice but was able to squeeze her hand. Mother then went to hospital, where patient was evaluated and released.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Eye irritation, Malaise, Ocular hyperaemia
Clinical narrative: Tachycardia, shortness of breath, malaise ("achy"), fever (101.8 degrees F), chills, eyes burning & red.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Tachycardia
Clinical narrative: Tachycardia, shortness of breath, malaise ("achy"), fever (101.8 degrees F), chills, eyes burning & red.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Local reaction at the site of injection...red & swollen.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Pt states she got the flu vaccine at approx 3:00 am 9/21/12 and developed generalized hives & itching abt 5 pm on 9-22-2012.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eye swelling, Eyelids pruritus, Pain of skin, Pruritus
Clinical narrative: Patient's eyelids started itching 3-4 hours after the vaccination. Sx got worse the next day. Pt. reported waking up with swollen eyes and redness in the upper facial areas. Her face was itchy and tender to touch. There was no adverse effect at the injection site. Pt has had regular strength influenza vaccine before w/o any adverse events.
Age: 59.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Facial pain, Pyrexia
Clinical narrative: Fever, pain in eyebrows during the day of 9/2012. Recovered by 9/21/12. No treatment necessary.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Continue arm pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother of child (MOC) reported swollen (R) thigh, 2.5 inches of redness. Child didn't complain of pain or itching. Pt was brought to hospital for eval & tx.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient told us that she has a fist size red spot that is warm to touch located below the flu vaccine injection site.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema
Clinical narrative: On 9/18/12 patient came into pharmacy at 7pm and received a ZOSTAVAX vaccine in the left deltoid and a flu vaccine in the right deltoid. On 9/21/12 nurse called in an antibiotic for redness at the site where ZOSTAVAX vaccine was administered.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a 26 years old female consumer refers to herself. The patient was vaccinated intramuscularly with her first dose of 0.5 ml GARDASIL (lot number not provided) in 2008. No other co-suspects were reported. No concomitant medications were reported. The patient was scheduled to receive her second dose in the near future. The patient explained that any subsequent doses after her next scheduled injection would occur after she had turned 27 years old. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 12 years old male patient with ADHD, unspecified episodic mood disorder, neurofibromatosis type 1 and post-traumatic stress disorder. The patient was vaccinated with lot # (670048/0963AA) dose 2 GARDASIL, IM, right deltoid on 29-DEC-2011 at 16:15. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient received immunization that was stored at a temp out of range <32 degrees F. No adverse reactions occurred. This is one of several reports from the same source. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report refers to a 27 years old female patient. The patient was vaccinated with GARDASIL (lot# was unknown) on 21-MAR-2012 at the age of 27. The outcome was unknown. Additional information has been requested
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot # unknown, 0.5 ml) intramuscular on 24-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The patient would receive her second dose of GARDASIL today (on 20-SEP-2012) and no adverse effect reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEP, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 years old female patient without pertinent medical history. The patient was vaccinated with intramuscular GARDASIL (lot # 672653/1860AA, expiration date 30-SEP-2012, 0.5 ml suspension/0,2 and 6 months). No other co-suspects were reported. Concomitant medications included hepatitis B virus vaccine (unspecified), ADACEL and MENACTRA. On 09-APR-2012 the patient who had received an injection of GARDASIL "had syncopy". No treatment was given for adverse event. The outcome of syncope was unknown. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a patient, who on 05-SEP-2012 was inadvertently vaccinated with a dose of VARIVAX (Merck), 0.65ml, subcutaneously, instead of ZOSTAVAX due to a staff error. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a registered nurse, concerning 4 patients, who on unknown dates were vaccinated with a dose of PNEUMOVAX 23 (dose and route not reported). It was reported that, in September 2012 ("last week") the patients experienced injection site reactions. At the time of the report, the patient's outcome was unknown. This is one of the several reports from the same reporter. The other linked reports included case # 1209USA008631, 1209USA008632 and 1208USA002950. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. The patient was administered "the first dose of MMR II (lot #, dose and route unknown) at age one year and the second dose of MMR II (lot #, dose and route unknown) at age three years." No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention.  Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a female who on 04-JUN-2011 was vaccinated with a first dose of VARIVAX (Merck) (Lot#664451/0693Y, route not reported) that expired on 15-MAY-2011. No adverse effects reported. Follow up information has been received concerning the 30 years old female patient who was vaccinated intramuscular into the deltoid with VARIVAX (Merck) (Lot#664451/0693Y) at clinic with military funds on 04-JUL-2011. This is one of several reports received from the same source. Additional is not expected.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 78 years old female patient. The patient had no known allergies. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot number was not provided) subcutaneous in left arm on 03-SEP-2012. No other co-suspects were reported. Concomitant medication included COUMADIN. Three days post vaccination. on 06-SEP-2012 the patient experienced injection site was red and hot to touch. Pharmacist stated since then, the reaction started to clear up, but now arm was pink in color that runs down her arm to her left elbow, and is warm to touch. The outcome was unknown at the time of report. The patient had called pharmacy to seek medical attention. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The reporter stated that the patient was vaccinated with 0.5 ml PNEUMOVAX 23 (lot # 669579/0595AA) intramuscularly on 10-SEP-2012 that had expired on 30-AUG-2012. No other co-suspects and concomitant medications were reported. No adverse effects reported. It was unknown if the patient had sought medical attention. This is one of two reports from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: Information has been received from a Registered Nurse concerning a 5 year old female patient with no drug reactions or allergies and with no pertinent medical history, who on 11-AUG-2005 and on 13-FEB-2009 was vaccinated with the first and second dose of VARIVAX (Merck) (dose and route not reported, lot #s 650227/1110P and 662184/1398X), respectively. No other co-suspects were reported. No concomitant medications were reported. It was reported that, on 22-JUL-2012, the patient developed rash described as "several, about 10 - pimples, hollow, <1mm to 2mm on trunk. Less of 50 lesions with no fever. It was also reported that the patient did not have history of chicken pox. It was reported that the patient was diagnosed with rash on 23-JUL-2012 by the physician. No laboratory tests were reported. The patient recovered from rash on 27-JUL-2012 (duration: 6 days). Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Back disorder, Back pain, Blister, Blood test normal
Clinical narrative: This spontaneous report as received from a physician refers to himself who was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX on 24-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 26-AUG-2012 the patient experienced 4 to 5 vesicles on his left torso. The physician stated he had "pain in his back and itching and abdominal pain on his right side for the last several weeks." The physician went to his primary care doctor who have him a ZOSTAVAX vaccination 3 weeks ago. 2 days after the injection he got 4-5 vesicles on his left torso. He dismissed them as "bites". Then a day or two later, he started having knife like pain in his right back area about the thoracic area, itching around his right side and deeper pain in his right upper abdomen. His primary care doctor and he felt this maybe shingles and he was started on acyclovir for 7 days. The pain had persisted and no rash had ever come. He was having some back problems so he saw a doctor, and he suggested them did an ultrasound of his gall bladder and an MRI of his thoracic spine, to make sure this was not something else. Both were negative. Blood tests had been also been negative. From what he understood there had never been reported a case of shingles from the vaccination. Since he did not get a rash, he could not confirm this. The pain persists but was gradually getting better. It felt like a post neuralgia of some type. He wanted to talk with the doctor to see if he/she had any other ideas than letting it run its course. He was scheduled for surgery on his neck  next week and therefore he had been concerned about identifying what it was. He did not assume antibody tests would do any good, but it there were a way to see if this was varicella it might reassure him. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging normal, Nuclear magnetic resonance imaging thoracic normal, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a physician refers to himself who was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX on 24-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 26-AUG-2012 the patient experienced 4 to 5 vesicles on his left torso. The physician stated he had "pain in his back and itching and abdominal pain on his right side for the last several weeks." The physician went to his primary care doctor who have him a ZOSTAVAX vaccination 3 weeks ago. 2 days after the injection he got 4-5 vesicles on his left torso. He dismissed them as "bites". Then a day or two later, he started having knife like pain in his right back area about the thoracic area, itching around his right side and deeper pain in his right upper abdomen. His primary care doctor and he felt this maybe shingles and he was started on acyclovir for 7 days. The pain had persisted and no rash had ever come. He was having some back problems so he saw a doctor, and he suggested them did an ultrasound of his gall bladder and an MRI of his thoracic spine, to make sure this was not something else. Both were negative. Blood tests had been also been negative. From what he understood there had never been reported a case of shingles from the vaccination. Since he did not get a rash, he could not confirm this. The pain persists but was gradually getting better. It felt like a post neuralgia of some type. He wanted to talk with the doctor to see if he/she had any other ideas than letting it run its course. He was scheduled for surgery on his neck  next week and therefore he had been concerned about identifying what it was. He did not assume antibody tests would do any good, but it there were a way to see if this was varicella it might reassure him. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: HEPA
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 70+ years old female patient refers to herself with no drug reactions/allergies. The patient was vaccinated with VAQTA (Lot #, dose/frequency, route unspecified) around September 2010. Concomitant medications included typhoid vaccine (unspecified) and a long list of antiviral medicine. The patient mentioned that in October 2010, "3 weeks later she received immunizations" she broke out in shingles, which was confirmed by a doctor. She said she got VAQTA and typhoid vaccine from the Health Dept, but did not recall the name of the clinician who administered the vaccines. She also said that she went to the doctor right away and was given an antiviral drug (provided within 24 hours) but did not know which one. She claimed she was still experiencing PHN which she said was from having the shingles. No lab diagnostics studies was performed. The outcome of shingles was unknown. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a nurse refers to a 70 years old female patient. On 17-AUG-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot: not reported). The nurse stated from physician's office that the patient was using ZOSTAVAX and on an unspecified date experienced cellulitis (also reported as cellulites) to the right arm. The patent was put on treatment KEFLEX. The patient sought medical attention office visit. At the time of the report, the outcome of cellulitis to the right arm was unknown. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to 32 years old patient who on 19-SEP-2012, was vaccinated erroneously with a dose of ZOSTAVAX subcutaneously (dose and lot number not reported) instead of second dose of VARIVAX (Merck). No adverse symptoms were reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Swollen tongue, Tongue discolouration
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 66 years old female patient with hypothyroidism, erythromycin allergy, LIPITOR allergy and epinephrine allergy. On 31-AUG-2012, the patient was vaccinated with a single dose of ZOSTAVAX (lot # 672675/0068AE). Concomitant medications included CYTOMEL and SYNTHROID. The Medical Assistant stated that on 01-SEP-2012, the patient developed a swollen, blackened tongue. On 04-SEP-2012, the patient went to the office and was put on treatment with BENADRYL and saline gargles. The patient was advised to see an ear, nose and throat (ENT) specialist if the symptoms did not resolve at 1 week. Lab diagnostics were not performed. At the time of the report, the patient was recovering from swollen blackened tongue. Additional information has been requested.
Age: 89.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The reporter stated that the patient was vaccinated with 0.5 ml PNEUMOVAX 23 (lot # 669579/0595AA) intramuscularly on 10-SEP-2012 that had expired on 30-AUG-2012. No other co-suspects and concomitant medications were reported. No adverse effects reported. It was unknown if the patient had sought medical attention. This is one of two reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Chest pain, Dizziness, Laboratory test, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Light Headed, tingling limbs and face plus throw up plus pain in chest and left arm and other more semingly random areas. Went to emergency room on 6/22/2012 for 11-hours and ruled out stroke with MRI and also heart check.  Symptoms lessened some on 6/23/2012 but increased on 6/24/2012.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Light Headed, tingling limbs and face plus throw up plus pain in chest and left arm and other more semingly random areas. Went to emergency room on 6/22/2012 for 11-hours and ruled out stroke with MRI and also heart check.  Symptoms lessened some on 6/23/2012 but increased on 6/24/2012.
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: DTaP was given to patient. Patient needed Tdap booster instead.
Age: 36.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Musculoskeletal pain, Oedema peripheral
Clinical narrative: Right arm red & swollen. Also, having shoulder pain.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: 1 hour after administration of flu vaccine - developed hives. Took BENADRYL with complete resolution.
Age: 56.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Ear pain, Nausea, Pain, Tremor
Clinical narrative: Nausea pain in all my body - head to toe jaw & teeth hurt, shaking hands (tremors) ears hurt, lasted about 2 days but worse the first day.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local swelling, Oedema peripheral
Clinical narrative: Mom called me at 8 pm 9/18/12 states "some arm is red and swollen" denies any other problems. Redness (on 9/19) measured 7cm x 10cm with swelling approx 5cm x 8cm no treatment needed.
Age: 0.37
Sex: F
Vaccine: IPV, RV5
Symptoms: Computerised tomogram abnormal, Haemorrhage, Injection site erythema, Injection site inflammation, Intussusception
Clinical narrative: 7-26-12 - Vaccinated. 7-26 - 7-28 - Red inflammation at injection site. 8-1 - Respiratory illness symptoms. 8-2 - Listless, vomiting, blood filled diaper. Required IV fluids, surgery for intussusception hospitalization.
Age: 0.37
Sex: F
Vaccine: IPV, RV5
Symptoms: Listless, Respiratory disorder, Surgery, Vomiting
Clinical narrative: 7-26-12 - Vaccinated. 7-26 - 7-28 - Red inflammation at injection site. 8-1 - Respiratory illness symptoms. 8-2 - Listless, vomiting, blood filled diaper. Required IV fluids, surgery for intussusception hospitalization.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site since vaccine administration on 9/7/12.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN3, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, red and warm at touch left deltoid. Mother noticed at 2 PM 9-25-12 - after vaccine child went to school - no fever, no other symptom.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Erythema, Lethargy, Nodule, Pain
Clinical narrative: Arm broke out. Redness, swelling about size of 50 cent piece, knot - lethargy, pain. Blisters under tongue & bilateral ears.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Swelling, Tongue blistering
Clinical narrative: Arm broke out. Redness, swelling about size of 50 cent piece, knot - lethargy, pain. Blisters under tongue & bilateral ears.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Herpes zoster, Urticaria
Clinical narrative: Large red welt with redness noted on entire deltoid region of arm x 5 days on 9/4 symptoms of shingles started. Shingles persisted x 2 wks. (? coincidence).
Age: 94.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Injection site haematoma
Clinical narrative: Client came by the pharmacy on 9/12/12 PM and showed a big bruise on his right arm. The bruise is about the size of a fist and located below the flu vaccine injection site. Bruising also on LA but not as big as RA's bruise.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Arthropod bite, Headache, Pyrexia, Urticaria
Clinical narrative: Initial report was received 17 September 2012 from a health care professional. A 24-year-old female patient had received an intramuscular injection of ADACEL, lot number C4136BA (site not reported) on 07 September 2012, and 24 hours later, she developed fever and headache that lasted two days. The patient had an insect bite on her left leg on 14 September 2012. The next day on 15 September 2012, she was seen in the office for severe hives widespread over her body. She had no difficulty breathing or swallowing. Corrective treatments consisted of Prednisone on 16 September 2012 with some relief to hives. The patient experienced a recurrence of hives overnight and was currently in the office for evaluation at the time of the report. Outcome was not recovered. Document held by sender: None.
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Pneumonia
Clinical narrative: This is an initial spontaneous report by a non contactable consumer. This female consumer reported on behalf of a male patient who was administered with first dose of PREVNAR 13 (Lot # E88939) unknown dose unknown frequency on his thigh for an unknown indication on 17Jan2011. Relevant medical history was unknown. Relevant concomitant medications were unknown. This office staff mentioned that he was administered with second dose on 17Mar2011, third dose was administered on 16May2011 and fourth dose was administered in 2011. Vaccines given on the same day included ROTATEQ, DAPTACEL and HIB. Vaccines taken within the last four weeks were none. In 2011 while on PREVNAR 13 unknown dose unknown frequency he was infected with pneumonia with stereotype 16F. Relevant lab data was unknown. At the time of the report it was unknown if he was still on PREVNAR 13. At the time of the report clinical outcome of above mentioned event was unknown.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Neck injury, Neck pain, Spinal X-ray abnormal, Spinal osteoarthritis
Clinical narrative: Initial report was received from a consumer on 29 November 2011, who is also the patient. A 57-year-old female patient had received an Intramuscular (IM) injection of INFLUENZA VACCINE (lot number not reported) in right deltoid on 12 October 2011. On 13 October 2011, the patient woke up with a very bad pain in the left side of her neck. The patient was seeing in an urgent care center and will be starting physical therapy in three weeks. No further informational was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Follow-up information was received from a consumer on 19 March 2012. The patient received FLUZONE, sanofi pasteur Inc., lot number UH463AB. The patient received physical therapy two times a week for approximately three months. The patient's neck was better than it was since the onset of the neck pain, however, the neck pain was still present but on a lesser scale. The patient could not turn her neck with the full rotation that she had prior to the neck injury. The patient had no illness at the time of vaccine and received no other vaccinations within four weeks of FLUZONE. The patient's outcome remained not recovered. Follow up information received on 30 April 2012: The patient reported that she was seen twice at the urgent care. The patient reported that she had intense neck pain and was seen the first time and was told it would recover in few days but two weeks later when she visited the clinic for she still had neck pain at which she requested physical therapy. Follow-up received from a healthcare professional on 17 September 2012. Based upon the new information provided, this case has been upgraded to serious. Fourteen days after vaccination, the patient had a cervical spine x-ray with result of mild spondylosis on 26 October 2011. The patient also sought treatment with an internal medicine specialist on 20 December 2011. The patient's outcome remained not recovered. Documents held by sender: None.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pruritus, Injection site warmth
Clinical narrative: Following vaccination, pt. developed a 2 inch red, warm, severely itchy spot at the site of administration that worsened over 24 hours. Hard nodule was also noted.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 9/21 - Site reaction - red, hot, swollen. Pt states she had same reaction last year, perhaps at pharmacy. Pt has taken BENADRYL and used cold compresses. 9/26 - pt. states swelling and redness much improved.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Headache, Lacrimation increased, Pain
Clinical narrative: Headache, body aches, runny nose, runny eyes, dizziness, elevated blood pressure beginning 6 hours after flu shot.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: Headache, body aches, runny nose, runny eyes, dizziness, elevated blood pressure beginning 6 hours after flu shot.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Myalgia, Pyrexia
Clinical narrative: Fever of 100 degrees, chest tightness, severe muscle aches.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Fever, 102 degrees F.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Rash macular
Clinical narrative: Blotchy, flat rash noted by parent on trunk of body upon on waking. No fever, any other adverse symptoms reported.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Flushing, Pain, Poor quality sleep
Clinical narrative: FELT VERY WEAK AND FLUISH, BODY ACHES NOT A GOOD NIGHTS SLEEP. FELT BETTER BY NOON ON THE 26TH
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Cough, Diarrhoea, Lethargy, Pyrexia
Clinical narrative: LETHARGY, COUGH, RUNNY NOSE, LOW GRADE FEVER, DIARRHEA, UPSET STOMACH.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: LETHARGY, COUGH, RUNNY NOSE, LOW GRADE FEVER, DIARRHEA, UPSET STOMACH.