chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Infantile spitting up, Oral administration complication, Regurgitation
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 2 month old male patient without drug reactions/allergies. The patient did not have pertinent medical history. On 05-JUL-2013 the patient was vaccinated with his first dose, 1ml ROTATEQ (lot number was reported as J004393, expiry date July 2014) orally. There was no concomitant medication. The patient received his first dose of ROTATEQ and spit it up. The infant had just eaten, but after regurgitating the vaccine, the infant was fine. No treatment was given for adverse event. No lab diagnostic studies were performed. The patient recovered from spit it up on 05-JUL-2013. The patient has sought medical attention. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Received ZOSTAVAX on 7/3/13. On 7/5/13 pt awoke with redness, marked swelling, warmth and mild itching around injection site. No systemic symptoms. Pt saw MD on 7/8/13 who confirmed irritant reaction. No sign of allergy.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Received ZOSTAVAX on 7/3/13. On 7/5/13 pt awoke with redness, marked swelling, warmth and mild itching around injection site. No systemic symptoms. Pt saw MD on 7/8/13 who confirmed irritant reaction. No sign of allergy.
Age: 24.0
Sex: M
Vaccine: HEP, TDAP, TYP
Symptoms: Rash
Clinical narrative: Patient developed rash on back after 3rd capsule.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Nodule, Tenderness
Clinical narrative: In the evening on day she received vaccines, noted tenderness in right arm pit area; progressed to nodule (3mm - solitary node in right axilla) Antibiotics prescribed on 6-26-13.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Pyrexia, Rash, Rash maculo-papular, Rhinorrhoea
Clinical narrative: Fever x 1 day even broke out into rash. Maculopapular rash on trunk runny nose.
Age: 10.0
Sex: M
Vaccine: HPV4
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Pt urinated 5-7 min after receiving GARDASIL. On his way out of bathroom became unconscious, hit head on wall, fell to ground. Brought into exam room, vitals taken, O2 administered, regained consciousness. Given water to drink and ice pack for head.
Age: 55.0
Sex: M
Vaccine: HEPA
Symptoms: Pruritus, Rash macular, Urticaria
Clinical narrative: 6/8 2013: Hives on both thighs 6/10 saw dr; Clobetasol prescribed 6/17 improving, mild discoloration 6/21 hives received to thighs and ABD - used clobetasol 6/26 improving, blotchy spots on ABD. 6/27 mild itching 7/3 increased itching, solid hive from knees to chest; BENADRYL and oatmeal baths 7/9 improving.
Age: 45.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Nausea
Clinical narrative: Mild headache and nausea after 1st capsule.
Age: 1.46
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left thigh at injection site is reddened in an area 3 inch x 1 3/4 inch, slight warm and induration. No other symptoms. No treatment needed, but can use ice to area and BENADRYL if wants to. T - 97.6 temporal.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA, HPV4, IPV, MMR, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: BP 98/62 Pulse 72 Respirations 20.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from an advanced Registered Nurse Practitioner (A.R.N.P) refers to an approximately 6-8 years female patient. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (Merck) (dose, route and lot number were not provided). The patient received her second dose of VARIVAX (Merck) (dose, route and lot number were not provided) when she was around 4-6 years of age. The advanced Registered Nurse Practitioner reported that about 2-3 weeks, approximately in June 2013, the child who had both VARIVAX (Merck), was exposed to her grandmother who had a herpes zoster breakout. The patient developed full blown cases of varicella, a pretty significant case of varicella. At the time of the report, the outcome of full blown case of varicella, a pretty significant case of varicella is unknown. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulits right arm at injection site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Oedema peripheral, Pain, Skin tightness, Skin warm
Clinical narrative: Child developed swelling from his elbow up to his shoulder. Right arm circumference was 9' and left arm was 7 1/2'. Area felt warm and tight, and it was painful to the touch. Primary care physician notified, child will be seen today.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction, Incorrect route of drug administration
Clinical narrative: There was adverse reaction with the injection being given IM instead of Subcutaneous.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness
Clinical narrative: Dizziness upon rising from bed and continuing on throughout the day.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Feeling hot, Headache, Hyperhidrosis, Immediate post-injection reaction, Pallor
Clinical narrative: Headache, sweating, warmth and pallor immediately after immunizations followed by syncope.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Headache, sweating, warmth and pallor immediately after immunizations followed by syncope.
Age: 1.02
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: MEASLES TYPE RASH ON BODY.
Age: 11.0
Sex: F
Vaccine: PPV
Symptoms: Delirium, Injected limb mobility decreased, Injection site erythema, Injection site infection, Pyrexia
Clinical narrative: Fever started evening of vaccine, next day fever shot to 104 - then taken to emergency room where next 4 days fever kept going up and down. 2 antibiotics every 6 hours and pain meds by IV. Delirious at times injection site red and infected couldn't move.
Age: 5.0
Sex: M
Vaccine: FLUN3, HEPA, VARCEL
Symptoms: Adenotonsillectomy, Convulsion, Dyspnoea, Electroencephalogram abnormal, Excessive eye blinking
Clinical narrative: Sxs started within 1wk after vac.-eyes rolling & looking up to left side, blinking. Ped Eye Spec. said prob. habitual, fine. Just after Christmas deep sighs in sleep, struggling to breathe (stop breathing for few seconds) saw PCP sent to ENT (tonsil hypertrophy-T&A done). After surgery tics got worse & twitching noticed in sleep (upper body), child complaining "tickles on head & back-PCP sent to Neurologist-EEG Abn. MRI normal (told S&S of seizures) by Neurologist.
Age: 5.0
Sex: M
Vaccine: FLUN3, HEPA, VARCEL
Symptoms: Eye movement disorder, Feeling abnormal, Gaze palsy, Muscle twitching, Nuclear magnetic resonance imaging normal
Clinical narrative: Sxs started within 1wk after vac.-eyes rolling & looking up to left side, blinking. Ped Eye Spec. said prob. habitual, fine. Just after Christmas deep sighs in sleep, struggling to breathe (stop breathing for few seconds) saw PCP sent to ENT (tonsil hypertrophy-T&A done). After surgery tics got worse & twitching noticed in sleep (upper body), child complaining "tickles on head & back-PCP sent to Neurologist-EEG Abn. MRI normal (told S&S of seizures) by Neurologist.
Age: 5.0
Sex: M
Vaccine: FLUN3, HEPA, VARCEL
Symptoms: Respiration abnormal, Respiratory arrest, Tic, Tonsillar hypertrophy
Clinical narrative: Sxs started within 1wk after vac.-eyes rolling & looking up to left side, blinking. Ped Eye Spec. said prob. habitual, fine. Just after Christmas deep sighs in sleep, struggling to breathe (stop breathing for few seconds) saw PCP sent to ENT (tonsil hypertrophy-T&A done). After surgery tics got worse & twitching noticed in sleep (upper body), child complaining "tickles on head & back-PCP sent to Neurologist-EEG Abn. MRI normal (told S&S of seizures) by Neurologist.
Age: 0.16
Sex: M
Vaccine: HIBV, PNC13, RV1
Symptoms: Bradycardia, Emotional distress, Heart rate decreased, Lethargy, Resuscitation
Clinical narrative: SHORTLY WITHIN 2-5 MINS AFTER ADMINISTERING THE ROTARIX, PREVNAR 13, AND HAEMOPHILUS INFLUENZAE, THE 2MTH OLD MALE INFANT STARTED TO GO INTO DISTRESS. HEARTRATE DECREASED BRADYCARDIA, LETHARGY, AND DR. HAD TO ASSIST WITH RAISING BABY'S HEARTRATE. GIVING CHEST COMPRESSIONS/ RESUSCITATION. CHILD WAS MONITORED AND SENT TO HOSPITAL FOR OBSERVATIONS.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt got a meningitis vaccine 2d ago, and that night the injected area was swollen, red, hot and pruritic.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dysstasia, Head injury, Loss of consciousness
Clinical narrative: After receiving Gardasil and waiting for 5 minutes, pt went to check out and she passed out and hit her head on door.  Couldn't stand by herself after 15 minutes, called ambulance and went to ER.  At discharge, mom went to get the car and child had a seizure.
Age: 0.33
Sex: M
Vaccine: DTPIHI, RVX
Symptoms: Allergy to animal, Asthma, Body temperature, Condition aggravated, Food allergy
Clinical narrative: Just shortly after the first set of shots he had a temperature and hives all over body and after second set of the same shots 2 months later it became worse resulting in an emergency trip to the hospital that week. He has severe allergies to animals and food. And asthma now. I seen it escalate after each set of shots he has had.
Age: 0.33
Sex: M
Vaccine: DTPIHI, RVX
Symptoms: Urticaria
Clinical narrative: Just shortly after the first set of shots he had a temperature and hives all over body and after second set of the same shots 2 months later it became worse resulting in an emergency trip to the hospital that week. He has severe allergies to animals and food. And asthma now. I seen it escalate after each set of shots he has had.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site urticaria, Pain, Urinary tract infection
Clinical narrative: Patient presents to the office for allergic reaction to pneumovax. Pt. developed pain initially, which resolved. However, she developed urticaria with erythema around the left upper extremity upper arm, involving circumference of arm. Pt. is currently on Cipro that started yesterday for UTI. She is also on warfarin, followed by Coumadin clinic. No fevers. On exam, there was erythema with urticaria formation that spanned the upper arm. no other region of involvement was present. a/p: 1. allergic rxn to pnNumovax-hydroxizine prn with side effects discussed. P.t has pt/inr ordered for 7/15/13. f/u in one week for reassessment. Pt. to go to ER should symptoms worsen
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Patient presents to the office for allergic reaction to pneumovax. Pt. developed pain initially, which resolved. However, she developed urticaria with erythema around the left upper extremity upper arm, involving circumference of arm. Pt. is currently on Cipro that started yesterday for UTI. She is also on warfarin, followed by Coumadin clinic. No fevers. On exam, there was erythema with urticaria formation that spanned the upper arm. no other region of involvement was present. a/p: 1. allergic rxn to pnNumovax-hydroxizine prn with side effects discussed. P.t has pt/inr ordered for 7/15/13. f/u in one week for reassessment. Pt. to go to ER should symptoms worsen
Age: 17.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Fatigue, Headache, Pyrexia
Clinical narrative: 7/6, 7/7: headache, stomach ache. 7/8: headache, stomach ache, tiredness. 7/9-7/10: extreme fatigue, headache, stomach ache, high fever (101.6-102 degrees)--no relief yet.
Age: 9.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site urticaria, Vaccination site oedema, Vaccination site warmth
Clinical narrative: 4cm diameter hive, warmth, edema over varicella vaccination site.
Age: 1.26
Sex: M
Vaccine: IPV
Symptoms: Urticaria
Clinical narrative: Hives facial area 7/9; then on arms also 7/10.
Age: 1.09
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Developed area of redness approx. 3cm round. Scantly raised and slightly warm to touch.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Fatigue, Myalgia, Nasal congestion, Pain
Clinical narrative: Fever, myalgias, fatigue, nasal congestion, local redness/swelling/pain. Treatment cool compresses and supportive care.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Fever, myalgias, fatigue, nasal congestion, local redness/swelling/pain. Treatment cool compresses and supportive care.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth, Lymphadenopathy
Clinical narrative: Right biceps (where shot was administered) became pink, slightly inflamed, hot to the touch and extremely sore across a broad area. The inflamed area and soreness spread over the next 24-36 hours, including lymph node swelling under the armpit, then receded. also had a fever of around 99.6 to 99.8 in the 36 hours after vaccination; temperature returned to normal inside 48 hours. Also had general muscle ache and soreness similar to a cold/flu, which escalated in the first 24-36 hours and went away with the fever within 48 hours. Treated with Benadryl and Acetaminophen twice when symptoms were most severe but it wasn't particularly helpful.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Right biceps (where shot was administered) became pink, slightly inflamed, hot to the touch and extremely sore across a broad area. The inflamed area and soreness spread over the next 24-36 hours, including lymph node swelling under the armpit, then receded. also had a fever of around 99.6 to 99.8 in the 36 hours after vaccination; temperature returned to normal inside 48 hours. Also had general muscle ache and soreness similar to a cold/flu, which escalated in the first 24-36 hours and went away with the fever within 48 hours. Treated with Benadryl and Acetaminophen twice when symptoms were most severe but it wasn't particularly helpful.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, soreness, swelling, itching at the site of injection. Been like this for 4 days.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Infection, Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: Redness, soreness, swelling, itching at the site of injection. Been like this for 4 days.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, soreness, swelling, itching at the site of injection. Been like this for 4 days.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, soreness, swelling, itching at the site of injection. Been like this for 4 days.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Infection, Local swelling, Pain in extremity
Clinical narrative: Redness, soreness, swelling, itching at the site of injection. Been like this for 4 days.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm
Clinical narrative: Redness, soreness, swelling, itching at the site of injection. Been like this for 4 days.
Age: 23.0
Sex: M
Vaccine: HPV4
Symptoms: Similar reaction on previous exposure to drug, Syncope
Clinical narrative: Patient fainted after receiving GARDASIL vaccine came to quickly but in falling out his (R) ear. States he has fainted before w/ vaccination.
Age: 0.34
Sex: U
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Abnormal faeces, Decreased appetite, Diarrhoea, Irritability, Vomiting
Clinical narrative: Watery stools hourly, along with vomiting on 7.6.13 and 7.7.13. No other family or contacts have been sick. Fussy, poor eating. Had seedy stool 7.9.13 but then had another watery stool. Appetite is improving as of 7.9.13.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Client rec'd VFC varicella-states he has had chick pox as a child. Needed vaccine for nursing classes. 24 hour later had redness, swelling, warmth 8 cm diameter redness with more red center with itching.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Rec'd varicella - district supplied - had redness, warmth and swelling 24 hours later - states he has not had chicken pox illness prior - size = 10 cm diam. with a more red center.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: About 11:40 am pt receives vaccine at pharmacy. Patient waits around store about 20 minutes. Leaves and comes back about 5 minutes after vaccines given with itchy, red rash on chest, neck, arms. Patient saw physician about 3:10 pm.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Left arm red, edematous, hot to the touch.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Somnolence
Clinical narrative: Left arm red, edematous, hot to the touch.
Age: 65.0
Sex: F
Vaccine: PPV, TD, PPV
Symptoms: Chills, Erythema, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Shaking chills, fever, nausea arm red and sore.
Age: 65.0
Sex: F
Vaccine: PPV, TD, PPV
Symptoms: Tremor
Clinical narrative: Shaking chills, fever, nausea arm red and sore.
Age: 65.0
Sex: F
Vaccine: PPV, TD, PPV
Symptoms: Chills, Pain, Tremor
Clinical narrative: Shaking chills, fever, nausea arm red and sore.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV1
Symptoms: Asthenia, Crying, Loss of consciousness, Pallor, Pyrexia
Clinical narrative: Patient received her 2 month old vaccines on 7/8/13. Per mom, 4 hrs after receiving vaccinations, baby stated crying excessively then turned "white and pale", no cyanosis, then turned weak, seemed to pass out few seconds. Mom called paramedic. Baby was doing well when paramedic arrived and continues to do well except for >1 fever, TYLENOL helps.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Papule, Pruritus, Skin exfoliation
Clinical narrative: Burning, erythematous, itching, peeling, papule 3/25 - until now. Pt tried to treat with NEOSPORIN.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a consumer reported an outbreak of VARIVAX (Merck). The news stated most of the children, on an unknown dates were vaccinated with a dose of VARIVAX (Merck) (lot# and doses not reported), but still developed the virus. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a claims examiner concerning a female who on 21-JUN-2013 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # J000434 with expiration date 10-APR-2014) and had an unspecified adverse reaction. It is unknown if the patient sought medical attention. At the time of reporting, the outcome was unknown. Additional information is not expected.
Age: 25.0
Sex: M
Vaccine: HPV4
Symptoms: Blister, Herpes zoster
Clinical narrative: This spontaneous report was received from the patient's mom concerning her currently 25 years old son. On an unknown date, the patient was vaccinated with GARDASIL dose 1 (doses, route of administration and lot # not reported). There were no concomitant, pertinent medical history or drug reactions/allergies. On an unknown date, after the first dose, the patient got a case of shingles. It was on his left hand side of his torso, had the blisters. The patient was given antibiotics but did not remember the name (also reported as the patient did not receive treatment for the event). The patient sought medical attention. It was reported that no lab diagnostic studies were taken. The outcome of got a case of shingles. It was on his left hand side of his torso, has the blisters is unknown. The patient discontinued the course of treatment and went in to get the remaining 2 shots. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a 17 year old female with no pertinent medical history and no drug reactions/allergies who on 18-SEP-1995 and 24-AUG-2011 was vaccinated subcutaneously with 0.5ml of the first and second dose of VARIVAX (Merck) (lot#665935/0157AA), a pregnancy registry product, respectively. The patient came to the physician's office on 11-AUG-2011 and the patient reported that she was pregnant (LMP: 21-AUG-2011, EDD: 27-MAY-2012). The patient's pregnancy was confirmed using a urine pregnancy test. The patient started on prenatal vitamins. No adverse effects were reported. Follow up information received from a pediatrician physician via a initial pregnancy questionnaire which reported that a multiracial 17 year old female patient with no previous pregnancies on 24-AUG-2011 was vaccinated with 0.5 ml of the second dose of VARIVAX (Merck) (lot#0157AA) (route not reported) at private MD office/hospital. The patient did not test for varicella antibodies before vaccinated with VZV containing vaccine. The patient had no local reaction at vaccination site, no varicella (chickenpox) symptoms post vaccination, and no herpes zoster (shingles) symptoms post vaccination. Follow up information has been received who reported that three attempts were made to obtain patient's pregnancy outcome and were unsuccessful. Case lost in follow up. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a physician, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 17 year old female patient, who on 12-NOV-2011 was vaccinated with a dose of VARIVAX (Merck) (Lot # 670216/0464AA, expiration date 31-MAR-2013) when pregnant (believed to be in the early second trimester). The patient was in a detention center when the vaccine was administered. The patient had an office visit with the physician that was following her pregnancy since the VARIVAX (Merck) was administered. The last menstrual period was approximately in July 2011 and the estimated delivery date would be in approximately April 2012. No adverse event was reported. Follow-up information has been received from a health care worker concerning the patient. It was reported that the patient was released from the center while pregnant and had no information to report about her pregnancy outcome. No further information was available. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Inappropriate schedule of drug administration, Syncope
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 17 year old female patient. There were reported no pertinent medical history, drug reactions or allergies. On 26-JUN-2013 the patient was vaccinated with the second GARDASIL 120 Y (lot # J003727, exp date 07-NOV-2015), 0.5 ml, intramuscular for immunization, at a routine vaccination visit. It was reported that the patient started therapy with GARDASIL (dose 1) on an unspecified date in 2010. Concomitant therapies included MENACTRA and HAVRIX. Healthcare worker stated that on 26-JUN-2013, 5 min after injections of GARDASIL, MENACTRA and HAVRIX, the patient felt dizzy and fainted. The patient lay down for 30 minutes af the office and then was able to walk without fainting. The outcome of patient felt dizzy fainted was reported as recovered/resolved on 26-JUN-2013. No treatment was given for the adverse event. No lab diagnostics studies were performed. The relationship between GARDASIL and the events was not reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site extravasation, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a 53 years old female consumer referring on herself. On 02-JUL-2013, she was vaccinated with the first dose of ZOSTAVAX, subcutaneous in the left arm. On 02-JUL-2013, the consumer stated that when the vaccine was administered a clear liquid dripped on her arm. She stated that the pharmacy advised her it was plasma. She states the pharmacy offered to re-administer the vaccine to be sure she was protected. She also stated that on her left arm, at the injection site, she has redness, pain, itching, and swelling, which started on 03-JUL-2013. No treatment was given for the events. The outcome of clear liquid dripped on her arm and the injection site, she had redness, pain, itching, and swelling was unknown. She sought medical attention. Attention information is not expected.
Age: 15.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, DTP, MEN
Symptoms: Syncope
Clinical narrative: Fainted, recovered, 2:30 PM fainted again, seized, required oxygen.
Age: 15.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, DTP, MEN
Symptoms: Convulsion, Syncope
Clinical narrative: Fainted, recovered, 2:30 PM fainted again, seized, required oxygen.
Age: 0.08
Sex: M
Vaccine: DTAP, HEP, MMR
Symptoms: Abnormal behaviour, Fatigue, Pyrexia, Rash, Restlessness
Clinical narrative: Began fever Sat morning. Untreated until Sat evening when temp read at 103.4 deg fahrenheit. Began dosing with baby acetaminophen and ibuprofin alternating. Baby had screaming fits and acted tired but restless. Fever came back high when meds wore off. Finally on Tuesday at 3am fever broke. Tuesday baby had signs of light rash and is still acting odd but has no more high fever.
Age: 0.08
Sex: M
Vaccine: DTAP, HEP, MMR
Symptoms: Screaming
Clinical narrative: Began fever Sat morning. Untreated until Sat evening when temp read at 103.4 deg fahrenheit. Began dosing with baby acetaminophen and ibuprofin alternating. Baby had screaming fits and acted tired but restless. Fever came back high when meds wore off. Finally on Tuesday at 3am fever broke. Tuesday baby had signs of light rash and is still acting odd but has no more high fever.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Local reaction
Clinical narrative: This spontaneous report as received from a pharmacy via a company representative, refers to 5 patients of unknown age and gender. No medical histories were provided. On unknown dates the patients were vaccinated with ZOSTAVAX (19400 PFU, subcutaneous injection, lot# J000433, exp date 10-APR-2014). No concomitant medications were reported. The pharmacist noted that out of the six recent doses administered there appeared to be a "higher than normal" number of localized, injection-site reactions. The severity was unspecified. All six doses, with five resulting is adverse reactions, came from the same box. The pharmacist had not stopped to use the lot in question. The outcome of localized injection site reactions was unknown. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Drug ineffective, Erythema, Paraesthesia, Post herpetic neuralgia
Clinical narrative: Patient developed shingles.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Skin lesion
Clinical narrative: Patient developed shingles.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction, Pyrexia
Clinical narrative: Slight redness to LT upper thigh and low-grade fever began eve. of imm. (07-08-13). Increased in size --> seen today in office --> app 3x4 cm area of erythema at site with slight warmth and induration. Afebrile today. (Mild-mod. localized reaction). Tx with PRN children's ADVIL and BENADRYL.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: This spontaneous report as received from a 59 year old female patient. On 03-JUL-2013 the patient was vaccinated subcutaneously with a single 0.65 ml dose of ZOSTAVAX (Lot# not reported). On 03-JUL-2013 the patient experienced large red marks of approximately 2" in diameter. The patient also noted small blistering and itchiness. The patient did not seek medical attention. No treatment was given. At the time of this report the patient was not recovered. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Syncope
Clinical narrative: Fainting episode after HPV vaccination on 7/10/13 at approx 2 PM. Patient out for approx 15 sec. Eased to floor with 2 nurses present and patients mother. Sat for approx 5 min and was able to stand independently.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Cataplexy, Narcolepsy
Clinical narrative: This spontaneous report as received from a consumer refers to his 15 year old daughter with none of Pertinent Medical History and Drug Reactions/Allergies. On an unknown date the patient was vaccinated with the first, second and third dose of GARDASIL (lot number, dose, and frequency were not provided). On an unknown date the patient experienced cataplexy and narcolepsy after receiving the third shot of GARDASIL. The patient saw the doctor. Routine blood work was performed which result was not provided. The outcome of cataplexy and narcolepsy was reported as not recovered/not resolved. The causality of event was not provided. Additional inforamtion has been requested.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: Lt. upper thigh red and warm to touch beginning day after imm. Decreased erythema on exam 07/10/13, but (+) firm near site. Afebrile. 6 cm x 4 cm area of (erythema). (Mod. localized imm. reaction). Tx with PRN children's BENADRYL, ADVIL and ice pks.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: (+) erythema with slight firmness at injection site to (Rt) upper arm began day after imm. Seen 7/11/13 at PCP - 6cm x 9cm area redness; small induration no warmth afebrile - mod. localized imm. reaction. Tx -I.P. children's BENADRYL and ibuprofen.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cough
Clinical narrative: Vaccines given. Starting coughing constantly approx 5-10 min. later. O2 sat 100% RA. BENADRYL 18mg po, ORAPRED 40mg po, Epi 1:1000 0.2 ml 1 SQ, Albuterol 2.5mg neb given.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site induration, Vaccination site pain
Clinical narrative: Local induration, tenderness, redness and itching at vaccination site (shingles) (R) triceps administered at local pharmacy.
Sex: M
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Oral administration complication, Vomiting projectile
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. In 2012 ("about one year ago"), the patient was vaccinated with ROTATEQ, orally, lot #, dose and frequency unspecified. The patient experienced projectile vomiting in the office immediately after administration of ROTATEQ. No treatment or medical attention was provided. The outcome of the patient was unknown. This one of several reports received from the same reporter. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.), for VARIVAX (Merck), a Pregnancy Registry product, concerning a 17 year old female patient with no drug reactions/allergies and no pertinent medical history who on 21-DEC-2011 was vaccinated with a dose of VARIVAX (Merck) (lot number 670654/0785AA) (dose and route were not reported) and subsequently determined that she was pregnant. There was no concomitant medication. The patient's last menstrual period was in October 2011. Expected date of delivery is in July 2012. There was no adverse effect reported. The patient sought medical attention by a follow-up visit. No lab diagnostics studies performed and no treatment was given. Outcome was unknown. Follow-up information was received from the registered nurse on 09-JUL-2012. Registered nurse reported that the patient never came back to the clinic for any follow-up and did not have any information regarding pregnancy outcome. She stated there was no forwarding HCP on record at the center. Case lost in follow-up. Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: Pt received TWINRIX 1 ml IM (L) deltoid 00910. Pt c/o lightheadedness and sweating at 0925. Pt given cup of lemonade. 0935 Pt began to be SOB. 50 mg BENADRYL IM at deltoid. Albuterol breathing tx.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Feeling hot, Paraesthesia, Rash
Clinical narrative: This spontaneous report was received from an approximately 68 year old female patient with rosacea, neomycin allergy (causes rash) and penicillin allergy (causes rash). The medical history of the patient included eczema. On 20-MAY-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). There were no concomitant medications. On 06-JUL-2013, the patient experienced rash, burning, prickling on the arm and feeling of heat on the neck after receiving PNEUMOVAX23. The patient sought medical attention (spoke to physician). She was treated with Clobetasol (dosage unspecified). No lab tests were performed. The patient was not recovered from the events at the time of reporting. The relatedness for all the events was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Acne, Arthralgia, Autoimmune disorder, Blood test
Clinical narrative: Bad acne, very tired, bad headaches, joint pain, auto-immune symptoms - bad circulation in hands and feet. Toe nails stopped growing and fell off. Swollen joints, hands, and feet, memory problems, zoning out, nausea, dizziness, upset stomach.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Immunology test
Clinical narrative: Bad acne, very tired, bad headaches, joint pain, auto-immune symptoms - bad circulation in hands and feet. Toe nails stopped growing and fell off. Swollen joints, hands, and feet, memory problems, zoning out, nausea, dizziness, upset stomach.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Joint swelling, Memory impairment, Nail growth abnormal, Nausea, Oedema peripheral
Clinical narrative: Bad acne, very tired, bad headaches, joint pain, auto-immune symptoms - bad circulation in hands and feet. Toe nails stopped growing and fell off. Swollen joints, hands, and feet, memory problems, zoning out, nausea, dizziness, upset stomach.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Onychoclasis, Poor peripheral circulation
Clinical narrative: Bad acne, very tired, bad headaches, joint pain, auto-immune symptoms - bad circulation in hands and feet. Toe nails stopped growing and fell off. Swollen joints, hands, and feet, memory problems, zoning out, nausea, dizziness, upset stomach.
Age: 0.4
Sex: U
Vaccine: DTAP, PPV
Symptoms: Injection site erythema, Injection site swelling, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a 4 month old patient of unknown gender. On 02-JUL-2013, the patient was inadvertently vaccination with a dose of PNEUMOVAX 23 (lot number, expiry date and dose unspecified), intramuscularly instead of the second dose of PREVENAR 13 series. On 09-MAY-2013, the patient had vaccinated with the first dose of PREVENAR 13 (lot number, expiry date, dose and route unspecified). Concomitant therapy included (unspecified), (reported as DTaP) (lot number, expiry date, dose and route unspecified) administered on 02-JUL-2013. On 02-JUL-2013, (unspecified) (reported as DTaP) site became swollen and red while the patient was in the office. The outcome of the events was unknown. The relatedness for the events was unknown for PNEUMOVAX 23 and (unspecified) (reported as DTaP). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot #, dose not provided), subcutaneously in the abdomen. No adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Rash post vaccination, dx of varicella, refer to OV notes attached.
Age: 24.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Wrong immunization given.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Same as box 7 I know it is a typical response but wanted it noted.
Age: 1.75
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Rash and redness right deltoid. Area hot to touch. Itching of site only. No fever. Treatment: Benadryl liquid by mouth. Cool compresses to area.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Lip swelling, Pruritus, Urticaria
Clinical narrative: Child awoke during night with posterior scalp itching severely.  Upon awakening in morning, lower lip was very swollen.  Bilateral forearms with hives, itching, and redness.  No swelling of tongue, throat, etc.  Gave Benadryl 50 mg.  Called child's pediatrician and allergist.
Age: 21.0
Sex: F
Vaccine: HPV2
Symptoms: Blood glucose increased, Dizziness, Dizziness postural, Motion sickness, Nausea
Clinical narrative: Day of vaccine blood sugar levels rose to 400 but was fine when corrected with insulin. The next day, 07/10/2013 experienced extreme drowsiness and when woke up around 3:00 pm was dizzy and felt like I was about to faint when walking, standing up, and sitting upright. Went to emergency room around 4:00pm and was told that I was experiencing a side effect of the Cervarix vaccine and that it could last for up to 72 hours, but if the problem persists that I would need to be rushed back to the hospital. They treated me for vertigo with meclizine for motion sickness and reglan(?) for nausea.
Age: 21.0
Sex: F
Vaccine: HPV2
Symptoms: Somnolence, Vaccination complication, Vertigo
Clinical narrative: Day of vaccine blood sugar levels rose to 400 but was fine when corrected with insulin. The next day, 07/10/2013 experienced extreme drowsiness and when woke up around 3:00 pm was dizzy and felt like I was about to faint when walking, standing up, and sitting upright. Went to emergency room around 4:00pm and was told that I was experiencing a side effect of the Cervarix vaccine and that it could last for up to 72 hours, but if the problem persists that I would need to be rushed back to the hospital. They treated me for vertigo with meclizine for motion sickness and reglan(?) for nausea.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Pallor
Clinical narrative: Five minutes post HPV injection patient felt dizzy, light headed and had pale complexion.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling, ? cellulitis on arm at site 24 hours s/p injection.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Patient came back to pharmacy about 24 hours after ZOSTAVAX administered with some swelling around the injection site, approximately 2" x 4" in upper arm. No other allergy symptoms, recommended BENADRYL and to keep an eye on it.
Age: 10.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None - just reporting given Tdap on 11/10/11 and 6/11/13.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Enlarged tender left anterior cervical node felt 10 min after injection. Markedly reduced in size by 20 min. We just kept him and watched him longer to make sure he was OK. Dr. then checked him again and released him.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The pharmacist placed a nurse on the phone who reported that on 08-JUL-2013, the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # 0482Z, expiry:03-DEC-2012). This was the patient's first dose of RECOMBIVAX HB. No adverse effect reported. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a 79 year old male patient concerning himself. 6 month ago, in January 2013 the patient was vaccinated with ZOSTAVAX (lot number, dose and injection site were not reported) (one time, subcutaneous). On 08-JUL-2013 the patient's doctor diagnosed him with shingles on his head and scalp. It had not blistered, but was painful and he said he had a rash on the right side of his head. The patient had seen his clinician for medical attention. Treatment was given as valacyclovir hydrochloride 1 gram taken every 8 hours. There was no lab diagnostics studies performed. The action taken and outcome were not provided. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Nausea, Pain, Tremor
Clinical narrative: Patient experienced severe headache followed by chills, body aches, body shakes and nausea.  Symptoms dissipated 4 hours after onset after taking Tylenol+codeine.  Symptoms restarted at 2:30 AM 7/11/2013 and pt took Tylenol.  Symptoms stopped at 7:00 AM.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain, Paralysis, Swelling
Clinical narrative: Swelling, Redness, Extreme pain, Paralysis.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt went in to Dr's office back on November 2012 to get a Flu shot, when Pt came out she felt her arm in bad pain but she thought it was normal because of the shot. Now shes been having really sharp pain in her left shoulder all the way down to her elbow or sometimes down to her wrist.
Age: 48.0
Sex: F
Vaccine: HEPA
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea in the afternoon after receiving vaccine then ran a fever and vomited the next morning.
Age: 1.04
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Awoke with fever of 102.  Continued with fevers ranging intermittently from 101 to as high as 104 through 7-11-13.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Diarrhoea, Oral herpes, Urticaria
Clinical narrative: Initial report was received from a healthcare professional on 01 July 2013. A 17-year-old female patient had received an intramuscular injection in the right deltoid of MENACTRA, lot number U4594AB on 24 June 2013. Five days post-vaccination on 29 June 2013, the patient broke out in generalized hives. She was evaluated and treated with epinephrine and MEDROL pack at the emergency department. On 01 July 2013, the patient was seen by a physician and was prescribed TAGAMET, ATARAX and VALTREX for cold sores and diarrhea. The patient denied any illness at the time of vaccination and had a history of scoliosis and no known allergies. Outcome was unknown. Documents held by sender: None.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 66 year old female patient. The patient's medical history included coronary artery disease (reported as CAD) and hypertension (reported as HTN). The patient had no drug reactions/allergies. On 02-JUL-2013 the patient was vaccinated ("probably" according to the reporter) with PNEUMOVAX23, 0.5 ml, intramuscular. Dose number was not reported. The lot number was reported as 8017759 with expiry date 04-JUL-2014 which was confirmed to be non valid. Concomitant therapies included apravastation (not further specified) lisinopril, carvedilol, bupropion hydrochloride, aspirin and albuterol. On 02-JUL-2013 the patient was seen in the emergency room with a 17 cm x 13 cm induration at injection site, swelling of the injection site (disability), pain at the injection site (disability) and fever of 101 F. The pain and swelling had limited the movement of the patient's arm. The physician stated that she had ruled out cellulitis and the she will be discharging the patient from the emergency room with medication to treat the pain. The patient was not hospitalized. The outcome of swollen injection site, painful injection site, fever of 101 F and induration at injection site was reported as not recovered/not resolved. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood test, Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous report as received from a consumer a 31 year old female patient with seasonal allergies. Medical history was not reported and no pertinent medical history. On 19-JUN-2013, the patient was vaccinated with VARIVAX (Merck) injection (dose, frequency, route and lot number were not reported).  There were no concomitant medications. The patient reported that she was pregnant (5 weeks). Estimated LMP 15-MAY-2013 and EDD of 19-FEB-2014. Blood work was performed (results unspecified). The patient sought medical attention, spoke with the physician. No adverse effects reported. The patient did not receive treatment. The pregnancy outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from the director of a health department via a company representative refers to an unspecified number of patients (reported as four other female and male patients) of unknown age. It was reported that on an unknown date the patients experienced fainting after receiving vaccination with an unspecified dose of GARDASIL (route, lot number and expiration date not reported) for prophylaxis and others unspecified shots (unspecified dose/frequency and unspecified manufacturer). The outcome of the event was unknown. This is one of several reports from the same source. Additional information has been requested.