chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.39
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site discomfort
Clinical narrative: Below is the documentation of the call made by the patient to the nurse: Patient called saying she had a tetanus shot Monday and has had a H/A since.  Denies head trauma, allergies, or sinus problems.  No fever and injection site slightly uncomfortable WNL (R deltoid).  H/A started about 4 PM Monday (5th) and persistent though today it is not as intense.  She has taken Aleve, ibuprofen, and Tylenol, all just taking the edge off.  Other than H/A, no other issues. I informed her H/A is a possible side effect and most normal side effects can last up to 3 days.  Today is the 3rd day and intensity is decreasing so to monitor today but if continues tomorrow or gets worse needs to seek med attention.  We have no appts today or tomorrow so will need to go to Urgent Care or ER.  She stated understanding. I tried reaching the patient several times to see if headache resolved and when but unsuccessful.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Post vaccination autoinoculation, Rash pustular, Scab, Vulval ulceration
Clinical narrative: AUTOINOCULATION OF LABIA MINOR, 8MM ULCERATION NOTED LATERAL TO FOSSA NAVICULARIS ON RIGHT AND LEFT LABIA MINORA. PUSTULE PRESENT ON RIGHT, SCAB/POSTULE ON LEFT. RESOLVING.
Age: 11.0
Sex: F
Vaccine: DTAP, MEN
Symptoms: Activities of daily living impaired, Feeling hot, Inflammation, Oedema peripheral, Pain in extremity
Clinical narrative: Her arm started getting more and more swollen, hot, and very painfull. We put cold packs on it and gave her ibuprophin. It just kept getting worse and worse, she missed two days of school because of it, the school nurse sent her home and said to do what we were already doing and if not better Monday the 12th to take her to her doctor. However, we just moved here and she doesn't have insurance or a doctor yet, so we just kept using the cold packs and ibuprofen for the pain and inflammation. Finally by the 16th it started to go down and started itching, but it is now the 19th and her arm is still a little swollen, slightly painful and discolored. Not sure what to do.
Age: 11.0
Sex: F
Vaccine: DTAP, MEN
Symptoms: Pruritus, Skin discolouration
Clinical narrative: Her arm started getting more and more swollen, hot, and very painfull. We put cold packs on it and gave her ibuprophin. It just kept getting worse and worse, she missed two days of school because of it, the school nurse sent her home and said to do what we were already doing and if not better Monday the 12th to take her to her doctor. However, we just moved here and she doesn't have insurance or a doctor yet, so we just kept using the cold packs and ibuprofen for the pain and inflammation. Finally by the 16th it started to go down and started itching, but it is now the 19th and her arm is still a little swollen, slightly painful and discolored. Not sure what to do.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Mom called with c/o redness at injection site, hives.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Arthralgia, Asthenia, Headache, Nausea, Pyrexia
Clinical narrative: Fever, nausea, vomiting, starting about an hour post vaccination c/o headaches, joint pain and nausea. Low energy with sleeping off and on per parent report. Resolved by 8PM and child was acting like normal self.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Somnolence, Vomiting
Clinical narrative: Fever, nausea, vomiting, starting about an hour post vaccination c/o headaches, joint pain and nausea. Low energy with sleeping off and on per parent report. Resolved by 8PM and child was acting like normal self.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and erythmeatous L after placing Tdap.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Acidosis, Amylase normal, C-reactive protein normal, Dehydration
Clinical narrative: Imm. given 8.9.13 - Abd pain/vomiting with increased Eosinophil off on starting 8.10.13. No other Sx. Extensive work up done - Normal. Admitted on 16th as progressed to dehydration. Was mildly acidotic no diagnosis could be made.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Differential white blood cell count abnormal, Eosinophil count increased, Full blood count abnormal, Lipase normal, Metabolic function test normal
Clinical narrative: Imm. given 8.9.13 - Abd pain/vomiting with increased Eosinophil off on starting 8.10.13. No other Sx. Extensive work up done - Normal. Admitted on 16th as progressed to dehydration. Was mildly acidotic no diagnosis could be made.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Urine ketone body present, Vomiting
Clinical narrative: Imm. given 8.9.13 - Abd pain/vomiting with increased Eosinophil off on starting 8.10.13. No other Sx. Extensive work up done - Normal. Admitted on 16th as progressed to dehydration. Was mildly acidotic no diagnosis could be made.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Eosinophil count increased, Full blood count abnormal, Metabolic function test normal, Urine analysis abnormal, Urine ketone body present
Clinical narrative: Imm. given 8.9.13 - Abd pain/vomiting with increased Eosinophil off on starting 8.10.13. No other Sx. Extensive work up done - Normal. Admitted on 16th as progressed to dehydration. Was mildly acidotic no diagnosis could be made.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Imm. given 8.9.13 - Abd pain/vomiting with increased Eosinophil off on starting 8.10.13. No other Sx. Extensive work up done - Normal. Admitted on 16th as progressed to dehydration. Was mildly acidotic no diagnosis could be made.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction, Diabetes mellitus, Local swelling, Pruritus, Reaction to preservatives
Clinical narrative: This spontaneous report as received from a 46 years female patient refers to herself. The reporter reported that about 20 years ago, in approximately August 1993, she experienced anaphylaxis after getting a dose of HEPTAVAX (dose, route and lot# unknown). 15 minutes post vaccination of HEPTAVAX her arms started swelling and itching, and she began wheezing. She sought medical attention and was immediately treated with Epinephrine and Intravenous BENADRYL. The patient fully recovered. The reporter stated she found out she was allergic to thimerosal in the vaccine. The patient had diabetic "now", but not at the time of vaccination. The outcome of the diabetic was not reported. Anaphylaxis was considered to be immediately life-threatening by the reporter. Upon internal review, anaphylaxis treated with intravenous BENADRYL was considered as other medically significant event. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Wheezing
Clinical narrative: This spontaneous report as received from a 46 years female patient refers to herself. The reporter reported that about 20 years ago, in approximately August 1993, she experienced anaphylaxis after getting a dose of HEPTAVAX (dose, route and lot# unknown). 15 minutes post vaccination of HEPTAVAX her arms started swelling and itching, and she began wheezing. She sought medical attention and was immediately treated with Epinephrine and Intravenous BENADRYL. The patient fully recovered. The reporter stated she found out she was allergic to thimerosal in the vaccine. The patient had diabetic "now", but not at the time of vaccination. The outcome of the diabetic was not reported. Anaphylaxis was considered to be immediately life-threatening by the reporter. Upon internal review, anaphylaxis treated with intravenous BENADRYL was considered as other medically significant event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Decreased appetite, Epistaxis, Headache, Hyperhidrosis
Clinical narrative: Headache; Nausea; Anorexia; Chills Sweats; Nosebleeds X2
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea
Clinical narrative: Headache; Nausea; Anorexia; Chills Sweats; Nosebleeds X2
Age: 45.0
Sex: M
Vaccine: YF
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever, headache, nausea, generalized aches and pain.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Redness developed after received injection, continued to swell over the next 3 days. Clinic visit on day 4. Deltoid area 7cm erythema w/3cm induration.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Allergy to vaccine, Eyelid oedema, Listless, Miosis, Pyrexia
Clinical narrative: Patient had a small redness develop under her right eye. Over the course of a few days and keeping it clean, the rash got redder and spread to her left eye also. After 1 week with no improvement, we took her to hospital. The ER doctor treated her for blepharitis and impetigo. he prescribed ophthalmic bacitracin and said the rash should be clear in 2-4 days. After 5 days it was worse yet with a rash now developing on other areas of her body; neck, toes, bottom, stomach, cheek. We took patient to another hospital. By now her eyes were nearly swollen shut. The doctor recommended a possible food allergy, but we haven't given her anything new to try in 2 months. The doctor then said the rash may be environmental and released us with a dose of Benadryl. I teach Kindergarten and showed our school nurse my baby's rash and instantly she said she believed it to come from a vaccine allergy. This rash began exactly 2 weeks after patient's vaccines. We are giving her Benadryl per doctor's orders and letting the rash "run its course". After one day with the antihistamine we are seeing remarkable improvements.  We were informed today -now 10 days in- that the rash most likely came from the Tdap vaccine and it seems to be "common" according to the nurse. The 1st time she had this vaccine, she screamed the entire night and was fine the next day. The 2nd time she received this vaccine, she ran a very high fever of 103.2 on Tylenol, she was listless for the entire next day, and her pupils were constricted. This time she had the same reaction as her previous dose and now the rash.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Rash erythematous
Clinical narrative: Patient had a small redness develop under her right eye. Over the course of a few days and keeping it clean, the rash got redder and spread to her left eye also. After 1 week with no improvement, we took her to hospital. The ER doctor treated her for blepharitis and impetigo. he prescribed ophthalmic bacitracin and said the rash should be clear in 2-4 days. After 5 days it was worse yet with a rash now developing on other areas of her body; neck, toes, bottom, stomach, cheek. We took patient to another hospital. By now her eyes were nearly swollen shut. The doctor recommended a possible food allergy, but we haven't given her anything new to try in 2 months. The doctor then said the rash may be environmental and released us with a dose of Benadryl. I teach Kindergarten and showed our school nurse my baby's rash and instantly she said she believed it to come from a vaccine allergy. This rash began exactly 2 weeks after patient's vaccines. We are giving her Benadryl per doctor's orders and letting the rash "run its course". After one day with the antihistamine we are seeing remarkable improvements.  We were informed today -now 10 days in- that the rash most likely came from the Tdap vaccine and it seems to be "common" according to the nurse. The 1st time she had this vaccine, she screamed the entire night and was fine the next day. The 2nd time she received this vaccine, she ran a very high fever of 103.2 on Tylenol, she was listless for the entire next day, and her pupils were constricted. This time she had the same reaction as her previous dose and now the rash.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pruritus, Rash, Urticaria
Clinical narrative: Hives and rash on hands, arms and neck, itchy and burning feeling.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Leg became swollen hard and red around where the shot was given. He said it hurt when I touched it and was affecting his running and seemed tired. The size of the wound was a total of 6-7" in diameter.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Eye pain, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Immediately after the RN administered the Tdap vaccination today at the Health Dept., my son complained of "stinging of eyes", and a moment later complained of "dizziness", "blurred vision", and subsequently collapsed. I immediately held him and took him in my arms, and prevented free fall to the ground. My wife immediately notified the front desk receptionist at the clinic, and the RN who administered the Tdap Vaccine responded, and other clinic staff. Later ARNP on duty also joined. A serial BP and pulse reading were recorded, as my son regained consciousness, we were advised by the the RN and ARNP on duty that the incident report will be filed the same day, and I was advised to file report to the VAERS.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Vision blurred
Clinical narrative: Immediately after the RN administered the Tdap vaccination today at the Health Dept., my son complained of "stinging of eyes", and a moment later complained of "dizziness", "blurred vision", and subsequently collapsed. I immediately held him and took him in my arms, and prevented free fall to the ground. My wife immediately notified the front desk receptionist at the clinic, and the RN who administered the Tdap Vaccine responded, and other clinic staff. Later ARNP on duty also joined. A serial BP and pulse reading were recorded, as my son regained consciousness, we were advised by the the RN and ARNP on duty that the incident report will be filed the same day, and I was advised to file report to the VAERS.
Age: 1.0
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Drug administered to patient of inappropriate age, Genital abscess
Clinical narrative: This case was reported by a healthcare professional (certified medical assistant) and described the occurrence of abscess on genital area in a 1-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included haemophilus influenzae type b vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given on 13 August 2013; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on 13 August 2013. On 13 August 2013 the subject received a dose of KINRIX (.5 ml, unknown route, unknown deltoid) as the 3rd dose in the DTaP and IPV series and experienced inappropriate age at vaccine administration. Per the reporter, the subject was "inadvertently administered" KINRIX. The subject was younger than the indicated age for KINRIX. KINRIX is indicated to be used as the fifth dose in the DTAP and the fourth dose in the IPV series. On 13 August 2013, 2 days after vaccination with KINRIX, the subject experienced abscess on genital area. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Age: 1.3
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Localized erythemic wheal appeared on (R) thigh within 10 minutes, prior to leaving the clinic. Ice pack was applied.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age.  The patient was administered the first dose of GARDASIL (dose, frequency, route and indication not reported) on an unspecified date in 2010 and the second dose in series "on time" on an unspecified date. Patient was in the office to receive the third dose in GARDASIL series on 13-AUG-2013. No adverse effects were reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: Had palpitations x 2-3 days. Has since gotten much better.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Patient complained of (L) arm being very sore. By 8/9/13 entire upper arm - shoulder to elbow hard, swollen, hot and red. Took BENADRYL and ALEVE by mouth routinely for 3 days. By 8/10/13 area of redness only 4 inches of upper arm and deltoid, pink and swollen but not hard or hot to touch.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling
Clinical narrative: Lips swelling, post shot, delayed onset. >48 hours after shot.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: Redness, swelling and pain from injection site all the way down to lower arm (left arm).
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Redness, swelling and pain from injection site all the way down to lower arm (left arm).
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site urticaria, Local swelling
Clinical narrative: Right arm swelled - solid wheep at injection site and it pussed up.
Age: 30.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Breast swelling, Breast tenderness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left deltoid swollen, reddened, warm to touch and client c/o pain when area is touched. Client states unable to sleep. Swelling extends under left arm to left breast with warm/tenderness. Client instructed to go to PCP/ER. Client did go to PCP 8/19/13 - swelling down - no pain.
Age: 30.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site warmth, Insomnia, Skin warm
Clinical narrative: Left deltoid swollen, reddened, warm to touch and client c/o pain when area is touched. Client states unable to sleep. Swelling extends under left arm to left breast with warm/tenderness. Client instructed to go to PCP/ER. Client did go to PCP 8/19/13 - swelling down - no pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left thigh red and swollen. Hydrocortisone, diphenhydramine. Rx' d given 8-19-13 patient to return to clinic as needed.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site reaction
Clinical narrative: -Injection site reaction - Immediate
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Swelling
Clinical narrative: Redness, swelling, unable to raise arm to 90 degrees. DO with Keflex.
Age: 24.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Pt fainted after receiving immunizations. Regained conscious right after. Monitored v/s in clinic for 1 hour. Alert and oriented x 3 and stable when discharged. No other s/s presented.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right upper arm with severe swelling, redness, pain, and tenderness from right shoulder to right elbow. Right upper arm increased in size by an estimate 50 percent.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Mom states that redness and swelling appeared Sunday morning 12 x 13 cm, not sure if it is from Tdap or MCV 4, both vaccines were given in left deltoid. Started treatment 8-19-2013 of prednisone 20 mg BID for 2 days.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: Unevaluable event
Clinical narrative: Mom concerned about the vaccine (TDAP) that is required for client to attend 7th grade. Afraid of SE. Was told not to immunize due to Hx.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: S and S consistent with febrile seizure the next day. Low grade temp at ER. Refer to neurologist.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a physician concerning a female patient of unknown age. There was no pertinent medical history and no drug reactions or allergies. On 20-SEP-2000, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number, expiry date, dose and route unspecified). There were no concomitant medications. On an unknown date, the patient developed chickenpox after receiving VARIVAX (Merck) and approximately on an unknown date in August 2013 (this past weekend), the patient was diagnosed with shingles. The patient was prescribed an unspecified antiviral approximately on an unknown date in August 2013 (this past weekend) after being diagnosed with shingles. It was unspecified if any lab tests were performed. The patient was not recovered from chickenpox and shingles. The relatedness for chickenpox and shingles was unknown for VARIVAX (Merck). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a pediatric patient of unknown age. On 22-APR-2013 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (dose, route and lot# not reported) rather than VARIVAX (Merck). On 22-APR-2013, the pediatric patient was inadvertently administered ZOSTAVAX rather than VARIVAX (Merck). No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Infectious mononucleosis, Mononucleosis heterophile test positive
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 19 year old female patient. On an unknown date the patient was vaccinated with the second dose of GARDASIL (lot # not reported). The physician reported that the patient developed mononucleosis after receiving the second dose of GARDASIL (date unspecified). The date of the first shot in the series was unknown. It was unknown if the patient planned to continue with the GARDASIL series. Laboratory studies performed included unspecified lab test (diagnosis of mononucleosis). The patient came to doctor to seek medical attention and was given unspecified medication for treatment. The outcome of mononucleosis was reported as recovered/resolved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from the mother of the patient refers to her daughter (demographics unknown). On an unknown date the patient was vaccinated with the first dose of GARDASIL (lot # expiration, dose, route unspecified). On an unknown date the patient experienced pain at the injection site after received the first shot of GARDASIL. Action taken was reported as discontinued. The event outcome was unknown. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPVX, MEN, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Rash pustular
Clinical narrative: (L) arm swelling seen urgent care - no abscess give BENADRYL.
Age: 11.0
Sex: M
Vaccine: HPVX, MEN, TDAP, HPV4, MNQ, TDAP
Symptoms: Local swelling, Ultrasound scan
Clinical narrative: (L) arm swelling seen urgent care - no abscess give BENADRYL.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Antibody test, Antinuclear antibody, Blood creatine phosphokinase, Blood immunoglobulin G, C-reactive protein
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 17 year old female patient. On 08-JUL-2013 the patient was vaccinated with dose 1, GARDASIL (lot #, expiration date and route not reported). On 08-JUL-2013, 2 hrs after receiving GARDASIL patient developed Gross Hematuria. Her condition improved within 2 days of receiving GARDASIL. Blood test and Ultrasound were performed with no abnormalities. No treatment was rendered for the event. The patient sought medication attention by visiting the physician. Causality was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Complement factor C3, Complement factor C4, Culture urine, Full blood count, Haematuria
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 17 year old female patient. On 08-JUL-2013 the patient was vaccinated with dose 1, GARDASIL (lot #, expiration date and route not reported). On 08-JUL-2013, 2 hrs after receiving GARDASIL patient developed Gross Hematuria. Her condition improved within 2 days of receiving GARDASIL. Blood test and Ultrasound were performed with no abnormalities. No treatment was rendered for the event. The patient sought medication attention by visiting the physician. Causality was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Laboratory test, Red blood cell sedimentation rate, Urine analysis
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 17 year old female patient. On 08-JUL-2013 the patient was vaccinated with dose 1, GARDASIL (lot #, expiration date and route not reported). On 08-JUL-2013, 2 hrs after receiving GARDASIL patient developed Gross Hematuria. Her condition improved within 2 days of receiving GARDASIL. Blood test and Ultrasound were performed with no abnormalities. No treatment was rendered for the event. The patient sought medication attention by visiting the physician. Causality was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Blood test normal, Haematuria, Ultrasound scan normal
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 17 year old female patient. On 08-JUL-2013 the patient was vaccinated with dose 1, GARDASIL (lot #, expiration date and route not reported). On 08-JUL-2013, 2 hrs after receiving GARDASIL patient developed Gross Hematuria. Her condition improved within 2 days of receiving GARDASIL. Blood test and Ultrasound were performed with no abnormalities. No treatment was rendered for the event. The patient sought medication attention by visiting the physician. Causality was not reported. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 4 month old female patient with no pre-existing allergies, birth defects and medical conditions. The patient had no illness at time of vaccination. On 28-MAY-2013 09:30 AM the patient was vaccinated with the second dose of ROTATEQ (dose was unknown, lot # J001616, expiry date 06-SEP-2014) orally. On 09-JUN-2013, the patient experienced bloody diarrhea, no other symptoms. No lab tests and laboratory data. The outcome of event was reported as recovered/resolved on 10-JUN-2013. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HEPA, IPV, MMRV, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: Red pruritic spots at injection site on right thigh red patchy spots on chic chest back very itchy. Have sent pt for a varicella titer.
Age: 4.0
Sex: M
Vaccine: HEPA, IPV, MMRV, HEPA, IPV, MMRV
Symptoms: Antibody test, Injection site erythema, Injection site pruritus, Injection site rash, Pruritus
Clinical narrative: Red pruritic spots at injection site on right thigh red patchy spots on chic chest back very itchy. Have sent pt for a varicella titer.
Age: 4.0
Sex: M
Vaccine: HEPA, IPV, MMRV, HEPA, IPV, MMRV
Symptoms: Rash erythematous, Varicella virus test
Clinical narrative: Red pruritic spots at injection site on right thigh red patchy spots on chic chest back very itchy. Have sent pt for a varicella titer.
Age: 20.0
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 20 year old patient. On 12-AUG-2013 the patient was vaccinated with a dose of M-M-R II (lot# 1252AA, expiration date 01-AUG-2013)(dose, indication not reported), subcutaneously. No adverse effect reported. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 20 year old patient. On 12-AUG-2013 the patient was vaccinated with a dose of M-M-R II (lot# 1252AA, expiration date 01-AUG-2013)(dose, indication not reported), subcutaneously. No adverse effect reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Agitation, Anxiety, Back pain, Disturbance in attention, Fatigue
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 year old female patient with scoliosis and no drug reactions or allergies who on 27-JUN-2013, was vaccinated intramuscularly in her left deltoid with a 0.5 ml dose of GARDASIL (lot # H021608, Exp. Date: 13-AUG-2015). Concomitant therapies included PROTONIX. The registered nurse reported that the patient's mother informed physician on 17-JUL-2013 that the patient experienced behavorial changes and night sweats, after the patient received GARDASIL in approximately June 2013. The patient did not come to be seen. On 10-AUG-2013, the patient's mother reported that the patient experienced back pain and joint pain after receiving the vaccine. The mother reported that back pain and joint pain had become increasingly worse and debilitating. No treatment was given for the experience. No lab diagnostic studies were performed. At the time of the report, ,the patient's outcome was unknown. The patient sought medical attention by calling the physician. The mother planned to take the patient to see an orthopedic physician. The relatedness for behavioral changes, joint pain debilitating, joint pain, back pain and night sweats and GARDASIL was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Night sweats
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 year old female patient with scoliosis and no drug reactions or allergies who on 27-JUN-2013, was vaccinated intramuscularly in her left deltoid with a 0.5 ml dose of GARDASIL (lot # H021608, Exp. Date: 13-AUG-2015). Concomitant therapies included PROTONIX. The registered nurse reported that the patient's mother informed physician on 17-JUL-2013 that the patient experienced behavorial changes and night sweats, after the patient received GARDASIL in approximately June 2013. The patient did not come to be seen. On 10-AUG-2013, the patient's mother reported that the patient experienced back pain and joint pain after receiving the vaccine. The mother reported that back pain and joint pain had become increasingly worse and debilitating. No treatment was given for the experience. No lab diagnostic studies were performed. At the time of the report, ,the patient's outcome was unknown. The patient sought medical attention by calling the physician. The mother planned to take the patient to see an orthopedic physician. The relatedness for behavioral changes, joint pain debilitating, joint pain, back pain and night sweats and GARDASIL was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abnormal behaviour, Arthralgia, Back pain, Night sweats
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 year old female patient with scoliosis and no drug reactions or allergies who on 27-JUN-2013, was vaccinated intramuscularly in her left deltoid with a 0.5 ml dose of GARDASIL (lot # H021608, Exp. Date: 13-AUG-2015). Concomitant therapies included PROTONIX. The registered nurse reported that the patient's mother informed physician on 17-JUL-2013 that the patient experienced behavorial changes and night sweats, after the patient received GARDASIL in approximately June 2013. The patient did not come to be seen. On 10-AUG-2013, the patient's mother reported that the patient experienced back pain and joint pain after receiving the vaccine. The mother reported that back pain and joint pain had become increasingly worse and debilitating. No treatment was given for the experience. No lab diagnostic studies were performed. At the time of the report, ,the patient's outcome was unknown. The patient sought medical attention by calling the physician. The mother planned to take the patient to see an orthopedic physician. The relatedness for behavioral changes, joint pain debilitating, joint pain, back pain and night sweats and GARDASIL was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 65 year old female patient. On 11-AUG-2013, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # J001693, expiry date 08-MAY-2014, route was subcutaneous) in an unspecified forearm. Concomitant therapies included atenolol, simvastatin, lisinopril and hydrochlorothiazide. On an unknown date in AUG-2013, the patient developed reddened area at injection site. The outcome of reddened area at injection site was reported as not recovered. The patient sought medical attention on 14-AUG-2013. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Crying, Dermatitis diaper, Insomnia, Irritability, Pyrexia
Clinical narrative: Symptoms began as a fever and a red spotty rash around his mouth and also his diaper areas, and he had a fever of 102 degrees F.  Normally a quiet child, he was fussy and suddenly could not sleep longer than two hours without waking up and crying until held.  Over the next few days the rash spread over his entire body, yet his fever subsided.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Symptoms began as a fever and a red spotty rash around his mouth and also his diaper areas, and he had a fever of 102 degrees F.  Normally a quiet child, he was fussy and suddenly could not sleep longer than two hours without waking up and crying until held.  Over the next few days the rash spread over his entire body, yet his fever subsided.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Disturbance in attention, Feeling abnormal, Nausea, Respiration abnormal
Clinical narrative: Upon leaving the hospital, I felt very lightheaded and nauseated.  On my drive home, I was forced to pull over because I felt that I could not take a deep breath and my heart was beating very fast.  The dizziness and nausea continued, but the breathing issues was not severe and I continued home.  For the next three days, the nausea was constant and I had severe brain fog such that I could not concentrate or focus.  I called in sick the following day as I did not feel that I could safely do my job as an ICU nurse.  It eventually all passed, but took many days to feel normal again.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Multiple sclerosis, Nuclear magnetic resonance imaging, Optic neuritis, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an approximately 16 year old female patient with drug reactions/allergies to raspberries. On 11-JAN-2007 the patient was vaccinated with her first dose of GARDASIL (lot # 655619/1427F, exp date as 28-JUN-2009, 0.5 ml, intramuscular). On 12-MAR-2007 the patient was vaccinated with her second dose of GARDASIL (lot # 655618/0186U, exp date as 27-JUN-2009, 0.5 ml, intramuscular). Concomitant therapies included TOPAMAX, REBIF, and AZURETTE. The patient was diagnosed with multiple sclerosis in 2008 after presenting with symptoms of left optic neuritis. Patient had sought medical attention via office visit. MRI(Magnetic resonance imaging) was performed in 2008 with no result was provided. Treatment of REBIF was given for the event. The outcome of multiple sclerosis was reported as not recovered/not resolved. The nurse practitioner also reported that the patient had a PAP screening(Papanicolaou test) on 25-JUL-2013 that was positive for Human Papillomavirus (HPV). Upon internal review, multiple sclerosis was considered as other medical significant event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous
Clinical narrative: This spontaneous report was received from a consumer concerning his wife of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On unknown dates, the patient suffered multiple miscarriages after receiving GARDASIL. It was unspecified if the patient sought any medical attention. The reporter stated that he believed the ingredients within GARDASIL were the cause of the reproductive difficulty his wife experienced. Upon internal review the event multiple miscarriages was considered as medically significant. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Headache, Myalgia, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Muscle aches, flushing, fever, sore throat, red eyes, headache.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Muscle aches, flushing, fever, sore throat, red eyes, headache.
Age: 0.86
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Patient was given her 1st dose of VARIVAX on 8/13/13 in the left thigh and the next morning about 3:00 AM the mother noticed a rash at the injection site and the other thigh (i.e. right) which patient was scratching.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Computerised tomogram, Tremor, Unresponsive to stimuli
Clinical narrative: 2 hours after immunizations, had 1 minute episode of shaking and unresponsiveness.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Miller Fisher syndrome
Clinical narrative: Guillain Barre - Miller Fisher variant. Hospitalized IVIG followed by oral prednisone.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pulse absent, Respiratory arrest
Clinical narrative: Patient received FLUZONE vaccine approximately at 1:30pm. Allergic reaction occurred at 3:30pm - epinephrine 0.3mg injection delivered to patient. Lost pulse and breathing.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Mom reported childs Rt arm had small rash after injection and continued to get a larger red rash on most of Rt arm for 2 days.
Age: 18.0
Sex: M
Vaccine: RAB
Symptoms: Infectious mononucleosis, Pyrexia
Clinical narrative: Initial report was received from a consumer on 07 August 2013. An 18-year-old male patient had received a dose one injection of IMOVAX, lot number H1512-3 on 12 July 2013 and a dose two injection of IMOVAX, lot number H1512-3 on 19 July 2013. On about 28 July 2013, the patient developed a fever and had been diagnosed with "mono". No additional information was provided. Outcome was not recovered. Documents held by sender: None.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Chills, Erythema, Pruritus, Pyrexia
Clinical narrative: Right arm turned red, developed rash with itching. 24-48 hrs later, developed fever (102 degrees), chills with achy joints. She did not seek medical attention.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Right arm turned red, developed rash with itching. 24-48 hrs later, developed fever (102 degrees), chills with achy joints. She did not seek medical attention.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Headache, Hypersensitivity, Injection site swelling, Oropharyngeal pain
Clinical narrative: Swelling at injection site. Next day, headache, mild sore throat fatigue x 2 days. Dx allergic reaction. Rx Prednisone 30mg x 3 days.
Age: 1.57
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Urticaria
Clinical narrative: Received imm (PENTACEL and Hep A) 8/19/13. Hives all over. Onset this AM 8/20/13 when he woke from sleep. Mild-moderate hives over body about 24 hrs. after vaccines.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling Lt thigh at injection site at warm to touch-covering most of thigh area. Ibu and cool compress.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Was given varicella 8/9/13 broke out in shingle looking rash 2 days later on (L) lower leg.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Nodule, Skin warm
Clinical narrative: "Huge red circle" at "knot" warm to touch per mother on 7/31/13. Lt arm advised by MD to give TYL/MOTRIN seen by PCP 8/4/13 circle still present but improving.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Local swelling
Clinical narrative: Left arm swelling.
Age: 0.37
Sex: F
Vaccine: IPV
Symptoms: Pyrexia
Clinical narrative: Spiked fever 104.1 per parent, post IPV injection, patient to emergency room later same day - (ER notes included).
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Heart rate increased, Paraesthesia oral, Pruritus, Rash, Urticaria
Clinical narrative: 8/9/13 - presents with tingling around lips, rash neck (L) side of face with itching -> BENADRYL, DECADRON - later that evening seen in ER increased in P, hives. Rx PEPCID IV and SOLUMEDROL - returned to ER 8/10 with similar sx - PEPCID IV - 8/13 - improving.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient may have had a cellulitis component per physician's notes.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No medical history provided. On an unknown date the patient was vaccinated with GARDASIL (dose 1). Concomitant medication included unspecified migraine medication. On an unknown date the patient experienced her period one week prior receiving her second dose of GARDASIL. Then, she had her period again approximately one week (unknown date) following the administration of her second dose. The reporter stated she does not believe the patient had a pregnancy test prior receiving her second dose of GARDASIL. The patient sought medical attention by contacting the pharmacist. The outcome is unknown. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Oedema, Skin warm, Swelling
Clinical narrative: Swelling and edema started 1-2 hours after administration. Swelling was 5 inches by 6 inches, raised about 1 inch, and warm to the touch, based on provider's notes from that day. Treatment: Diphenhydramine 1 tab once, Cetirizine 1 tab once.
Age: 71.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Rash, Swelling
Clinical narrative: Symptoms: Skin Rash and swelling.
Age: 1.44
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Urticaria
Clinical narrative: Urticaria
Age: 51.0
Sex: F
Vaccine: MNQ
Symptoms: CSF test, Lumbar puncture, Myelitis transverse, Nuclear magnetic resonance imaging brain, Optic neuritis
Clinical narrative: Severe fulminant holocord transverse myelitis and bilateral optic neuritis.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HPV4
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: HPV vaccine administered in pts left deltoid. While attempting to lie down to rest, pt convulsed briefly for 2-3 seconds, passed out for a few seconds. Pt then came to and responded appropriately. Pt rested for 15 minutes with mom at bedside. Pt given granola and a drink, rested 5 more minutes then dismissed in stable condition.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HPV4
Symptoms: Convulsion, Loss of consciousness, Seizure like phenomena
Clinical narrative: HPV vaccine administered in pts left deltoid. While attempting to lie down to rest, pt convulsed briefly for 2-3 seconds, passed out for a few seconds. Pt then came to and responded appropriately. Pt rested for 15 minutes with mom at bedside. Pt given granola and a drink, rested 5 more minutes then dismissed in stable condition.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropod bite, Blister, Herpes zoster, Pain, Rash pruritic
Clinical narrative: On 8/2/12 I received a vaccine of ZOSTAVAX, 0.65 ml dose in my Rt arm. On 8/4/13 I noted a "bug bite", that was quickly joined by more itchy - painful spots. In about 4-5 days blisters erupted. My physician said it looked like shingles and prescribed Valacyclovir hCL - 1 gram tablets.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Vision blurred, Vomiting
Clinical narrative: Patient was found to be dizzy, reported blurred vision, and vomited on the floor. This was after vaccine was given, approximately 5 mins prior, in the afternoon.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Swelling face, Urticaria, Vomiting
Clinical narrative: Received GARDASIL #3 into (L) arm IM about 1100 on 8/13/13. About 1730 pt. had hives on chest, back, arms and face. Mom gave 50 mg BENADRYL. Had 2 emesis and 2 diarrhea that nite w/facial swelling. Facial swelling continued on 8/14 - gone by 8/15.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Gait disturbance, Headache, Joint stiffness
Clinical narrative: Muscle and joint stiffness so severe patient could barely walk. Malaise - stomach and headache, fatigue swollen ankles. Above symptoms began evening of 7-14-2013 and continued for approximately one month with daily improvement beginning 7-20-13.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Malaise, Muscle tightness
Clinical narrative: Muscle and joint stiffness so severe patient could barely walk. Malaise - stomach and headache, fatigue swollen ankles. Above symptoms began evening of 7-14-2013 and continued for approximately one month with daily improvement beginning 7-20-13.
Age: 28.0
Sex: M
Vaccine: HEP, TD
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Deltoid muscle swollen and painful. Limited range of motion - cannot raise arm more than 90 degrees. No weakness in grip. No numbnes or tingling of lower extremity.
Age: 55.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Erythema, Injection site oedema, Local swelling, Pain, Pyrexia
Clinical narrative: Pt. returned to clinic 8/16/13 c/o left arm mild edema (R), fever since 8/14/13 and mild reddened 2cm x 2cm on (L) arm. No drainage. KEFLEX 500g PO every 8 hr for a week. Pt. was seen on 8/19/13 for f/up and improve swollen/edema on arm. Pt. still reports fever and pain decreased, redness resolved.
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Muscular weakness, Pain, Paraesthesia
Clinical narrative: Patient c/o burning pain/weakness/tingling of left arm since vaccination was given. Denies ny local reaction (redness, swelling, etc) at site of vaccination. Further workup and treatment in progress.
Age: 13.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Abdominal pain upper, Dark circles under eyes, Decreased appetite, Feeling abnormal, Mood altered
Clinical narrative: Woke up not wanting breakfast, when she did eat she would complain of her stomach hurting.  Complained she didn't feel like eating, not hungry (this is not like her).  Now stating she does not feel good over all.  Under eyes are grey, over all deminished affect.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash generalised, Urticaria
Clinical narrative: Rash and welts started on trunk of body and spread to whole body.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: REDNESS SWELLING 7cm x 10cm.