chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood test normal, Blood thyroid stimulating hormone decreased, Culture urine positive, Delivery, Exposure during pregnancy
Clinical narrative: Information has been received from a consumer, for HPV vaccine, a Pregnancy Registry product, concerning her daughter, a 16 year old patient with acne and intermittent headaches and a history of major back surgery spinal fusion when 14 years old (in approximately 2009) and no drug reactions/allergies stated by the caller who on 10-AUG-2011 was vaccinated with the first dose of HPV vaccine (lot # not provided) in her right arm. Concomitant therapy included MENACTRA minocycline and ADVIL. A urine pregnancy test taken at home on 19-SEP-2011 was positive. The patient was seen by an obstetrician-gynecologist (OB/GYN) on 03-OCT-2011. Sonogram, and blood work labs were performed, and all are normal. It was reported that the patient was not experiencing any problems, no adverse effects. The LMP was 08-AUG-2011. Est Delivery Date was 14-MAY-2012. Follow-up information has been received from the consumer concerning her daughter with kyphosis resulting in spinal fusion and no previous pregnancy history who on 10-AUG-2011 was vaccinated with HPV vaccine (Lot number 06647 is an invalid lot number for HPV vaccine. On 03-OCT-2011, the patient had ultrasound which was normal. Additional information has been received from a certified medical assistant who concerning the single student with no known drug allergies who had menarche at 11 year old, menses monthly, frequency was 28-30 days. She had a history of murmur and irregular rhythm. On 20-SEP-2011 (previously reported as 19-SEP-2011), the patient had beta-human chorionic gonadotropin (HCG) test. On 12-OCT-2011, at about 6 weeks of gestation, an ultrasound was performed which showed EDD would be 06-JUN-2012 (previously reported as 14-MAY-2012). On 13-OCT-2011, hematocrit was performed which showed 38.5% and hemoglobin showed 132. At the time of reporting, the outcomes of murmur and irregular rhythm were unknown. Follow up information has been received from the certified medical assistant who reported that on 21-MAY-2012 the patient delivered a baby girl by spontaneous vaginal delivery. The baby was vigorous and apgar scores were 9 and 9. The baby weighed 5lb 13oz and was in excellent condition. She was a normal healthy infant. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Haematocrit normal, Haemoglobin normal, Hepatitis C antibody negative, Human chorionic gonadotropin positive, No adverse event
Clinical narrative: Information has been received from a consumer, for HPV vaccine, a Pregnancy Registry product, concerning her daughter, a 16 year old patient with acne and intermittent headaches and a history of major back surgery spinal fusion when 14 years old (in approximately 2009) and no drug reactions/allergies stated by the caller who on 10-AUG-2011 was vaccinated with the first dose of HPV vaccine (lot # not provided) in her right arm. Concomitant therapy included MENACTRA minocycline and ADVIL. A urine pregnancy test taken at home on 19-SEP-2011 was positive. The patient was seen by an obstetrician-gynecologist (OB/GYN) on 03-OCT-2011. Sonogram, and blood work labs were performed, and all are normal. It was reported that the patient was not experiencing any problems, no adverse effects. The LMP was 08-AUG-2011. Est Delivery Date was 14-MAY-2012. Follow-up information has been received from the consumer concerning her daughter with kyphosis resulting in spinal fusion and no previous pregnancy history who on 10-AUG-2011 was vaccinated with HPV vaccine (Lot number 06647 is an invalid lot number for HPV vaccine. On 03-OCT-2011, the patient had ultrasound which was normal. Additional information has been received from a certified medical assistant who concerning the single student with no known drug allergies who had menarche at 11 year old, menses monthly, frequency was 28-30 days. She had a history of murmur and irregular rhythm. On 20-SEP-2011 (previously reported as 19-SEP-2011), the patient had beta-human chorionic gonadotropin (HCG) test. On 12-OCT-2011, at about 6 weeks of gestation, an ultrasound was performed which showed EDD would be 06-JUN-2012 (previously reported as 14-MAY-2012). On 13-OCT-2011, hematocrit was performed which showed 38.5% and hemoglobin showed 132. At the time of reporting, the outcomes of murmur and irregular rhythm were unknown. Follow up information has been received from the certified medical assistant who reported that on 21-MAY-2012 the patient delivered a baby girl by spontaneous vaginal delivery. The baby was vigorous and apgar scores were 9 and 9. The baby weighed 5lb 13oz and was in excellent condition. She was a normal healthy infant. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Ultrasound scan normal
Clinical narrative: Information has been received from a consumer, for HPV vaccine, a Pregnancy Registry product, concerning her daughter, a 16 year old patient with acne and intermittent headaches and a history of major back surgery spinal fusion when 14 years old (in approximately 2009) and no drug reactions/allergies stated by the caller who on 10-AUG-2011 was vaccinated with the first dose of HPV vaccine (lot # not provided) in her right arm. Concomitant therapy included MENACTRA minocycline and ADVIL. A urine pregnancy test taken at home on 19-SEP-2011 was positive. The patient was seen by an obstetrician-gynecologist (OB/GYN) on 03-OCT-2011. Sonogram, and blood work labs were performed, and all are normal. It was reported that the patient was not experiencing any problems, no adverse effects. The LMP was 08-AUG-2011. Est Delivery Date was 14-MAY-2012. Follow-up information has been received from the consumer concerning her daughter with kyphosis resulting in spinal fusion and no previous pregnancy history who on 10-AUG-2011 was vaccinated with HPV vaccine (Lot number 06647 is an invalid lot number for HPV vaccine. On 03-OCT-2011, the patient had ultrasound which was normal. Additional information has been received from a certified medical assistant who concerning the single student with no known drug allergies who had menarche at 11 year old, menses monthly, frequency was 28-30 days. She had a history of murmur and irregular rhythm. On 20-SEP-2011 (previously reported as 19-SEP-2011), the patient had beta-human chorionic gonadotropin (HCG) test. On 12-OCT-2011, at about 6 weeks of gestation, an ultrasound was performed which showed EDD would be 06-JUN-2012 (previously reported as 14-MAY-2012). On 13-OCT-2011, hematocrit was performed which showed 38.5% and hemoglobin showed 132. At the time of reporting, the outcomes of murmur and irregular rhythm were unknown. Follow up information has been received from the certified medical assistant who reported that on 21-MAY-2012 the patient delivered a baby girl by spontaneous vaginal delivery. The baby was vigorous and apgar scores were 9 and 9. The baby weighed 5lb 13oz and was in excellent condition. She was a normal healthy infant. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Rash erythematous, Vaccination site reaction, Vaccination site warmth
Clinical narrative: 12/13/2013 client at clinic to receive 2nd dose of varicella vaccine. At time of visit client voiced after receiving varicella vaccine on 10/29/2013 that evening rash occurred ar var. vaccine site. Rash described as flat, red, warm to touch and covered large area of arm and lasted x 1 month. Did not seek medical attention or notify Health Dept. until today.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3
Symptoms: Complex partial seizures
Clinical narrative: Partial complex seizure approximately 7 hrs after vaccine.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Middle insomnia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Continued pain in shoulder, down to elbow (aching) sometimes sharp pain that wakes her up during night or during sudden movement.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Chills, Cough, Headache, Pyrexia
Clinical narrative: Fever, chills, headache, coughing.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site discharge, Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: Prevnar 13 and HIB given in right leg at 4 month visit that left raised red bumps with clear drainage. Mom states had fever after vaccines but did not report to physician until next checkup at 6 month visit on 12/16/13. No pain at injection sites. Dr. will treat for possible infection.
Age: 20.0
Sex: F
Vaccine: TYP, YF
Symptoms: Dizziness, Gait disturbance, Nausea, Visual impairment
Clinical narrative: Felt dizzy, vision started to black out, slight nausea, stumbled backwards then forwards & knelt down.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Fall, Paraesthesia, White blood cell count increased
Clinical narrative: Unsure of signs and symptoms course of time, pt. only been in ER and hospital. Started 11/25/13 w/back pain, S/P fall and paresthesias, discharged 11/29/13 and readmitted 11/30/13 for increased WBC's, w/? Guillain Barre and weakness, currently still in hospital on a rehab unit.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Dyspnoea, Intensive care, Lip swelling
Clinical narrative: Shortness of breath, weakness, dizziness last night. Patient is a 28-year-old female with past medical history significant for psoriasis who presented as above. Patient is a health worker who received a mandatory influenza shot between 8 and 8:30 p.m. last night. About two hours later she began experiencing some shortness of breath. She felt like there was a knot in her throat. She reported feeling dizzy, tachycardic. She reports that her lips began to swell and her hands began to swell, and this prompted her visit to the emergency room. She received some epinephrine, SOLU-MEDROL, and some BENADRYL and her symptoms began to somewhat subside. Plans were being made for discharge but soon after symptoms recurred. She received further treatment and was thereafter admitted to intensive care unit for further evaluation and management. At this time she reports significant resolution of her symptoms. She said she is now back to her baseline respiratory status. She reports she has never had an influenza shot before, and she has no prior history of anaphylaxis. She did have an adverse reaction to DARVOCET, but the reaction at that time was itching. At this time she denies any headaches or dizziness. She denied any chest pains. Denies any other complaints at this time.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Sensation of foreign body, Tachycardia
Clinical narrative: Shortness of breath, weakness, dizziness last night. Patient is a 28-year-old female with past medical history significant for psoriasis who presented as above. Patient is a health worker who received a mandatory influenza shot between 8 and 8:30 p.m. last night. About two hours later she began experiencing some shortness of breath. She felt like there was a knot in her throat. She reported feeling dizzy, tachycardic. She reports that her lips began to swell and her hands began to swell, and this prompted her visit to the emergency room. She received some epinephrine, SOLU-MEDROL, and some BENADRYL and her symptoms began to somewhat subside. Plans were being made for discharge but soon after symptoms recurred. She received further treatment and was thereafter admitted to intensive care unit for further evaluation and management. At this time she reports significant resolution of her symptoms. She said she is now back to her baseline respiratory status. She reports she has never had an influenza shot before, and she has no prior history of anaphylaxis. She did have an adverse reaction to DARVOCET, but the reaction at that time was itching. At this time she denies any headaches or dizziness. She denied any chest pains. Denies any other complaints at this time.
Age: 44.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Severe malaise, fever and local redness and swelling at site of Tdap and PNEUMOVAX ((L) deltoid) not sure if both vaccinations together or just one the cause.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Local swelling, Pain in extremity
Clinical narrative: Extreme pain and swelling at injection site, could not sleep on arm (R) swelling and pain descending from shoulder to upper arm, day 2, day 3 swelling down to elbow w/ pain and now lower arm pain and swelling cannot sleep on (R) side due to pain, within hours of vaccination could not use (R) arm due to extreme pain.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Erythema, Feeling hot, Injection site swelling, Rash macular, Swelling face
Clinical narrative: On 11-8-13 in A.M. swelling occurred from (L) shoulder to elbow. Redness with heat TYLENOL given, Friday evening swelling receding. Sat. 11/9 evening developed hives. BENADRYL given. 11/10 Sun. A.M. facial puffiness hives on back. 2% Hydrocortisone cream applied. 11/10 Sun. P.M. hives over entire back. BENADRYL given with effect. Mon 11/11 continued with splotchiness 2% Hydrocortisone applied. Tues 11/12 pt. not complaining of hives or itchiness.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Urticaria
Clinical narrative: On 11-8-13 in A.M. swelling occurred from (L) shoulder to elbow. Redness with heat TYLENOL given, Friday evening swelling receding. Sat. 11/9 evening developed hives. BENADRYL given. 11/10 Sun. A.M. facial puffiness hives on back. 2% Hydrocortisone cream applied. 11/10 Sun. P.M. hives over entire back. BENADRYL given with effect. Mon 11/11 continued with splotchiness 2% Hydrocortisone applied. Tues 11/12 pt. not complaining of hives or itchiness.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Soon after severe illness for one week.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Dysphonia, Erythema, Local swelling, Pruritus, Urticaria
Clinical narrative: Arm swelling and redness. Hoarseness. Hives and pruritus.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Large red area around where vaccine given on arm (about 4 inch diameter) warm to the touch and painful. Sent pt. to ER. Onset was approximately 12 hours after vacc. given.
Age: 91.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Rash
Clinical narrative: Rash.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Infection, Mobility decreased, Pain
Clinical narrative: Patient noticed within a day of shot hurt way more than previous flu shot (hurt very bad). Patient could not even lay on the arm when sleeping and it got worse. 4-5 days later patient went to MD and he said it was not infected and probably having a reaction and would get better but it has not and the patient is going to make another appt. Pt can move arm but horizontal movements are inhibited. Patient said she thought RPh gave shot too high.
Age: 27.0
Sex: F
Vaccine: HEPAB, VARCEL
Symptoms: Injection site induration, Injection site mass, Injection site pain
Clinical narrative: 7/23/13 Hard lump at VARIVAX injection site - applied ice. 7/24/13 Lump 3" across and painful. 7/26/13 Lump resolving - 1" and no longer painful.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Sore painful site of injection.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate decreased, Palpitations
Clinical narrative: 11/6/2013 1st signs 11/7/2013. Palpitations heart and right side of neck, night and day pulsating across back above R hip - low pulse 42-44 beat per min. I have a nervous system disorder. I read it after the shot.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Headache
Clinical narrative: One hour after vaccine administered patient developed headache and became lightheaded. Patient stated he felt better after 1-2 hours.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: 12/7 - Redness, swelling at injection site, hot to touch. Hives down arm on side of injection as well as on chest abdomen and R lower extremity. Pt also had diarrhea. Ice applied to site. Benadryl taken for 3 days. Benadryl cream applied to skin.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site rash
Clinical narrative: Inflamed, raised rash of about 5 cm in diameter at injection site (left arm).
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Patient reports she is unable to lift L arm w/o pain x 2 wks, rates pain 4-5 on pain scale.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 74 year old male consumer regarding himself without drug reactions/allergies or pertinent medical history. On 26-NOV-2013, the patient was vaccinated with ZOSTAVAX (dose, duration and lot were not reported). Concomitant therapies included simvastatin (Manufacturer unknown), flunisolide(manufacturer unknown) and loratadine (manufacturer unknown). On 10-DEC-2013, the patient developed the shingles after receiving ZOSTAVAX. On unknown date, the patient saw medical attention. On unknown date, the patient received treatment with aciclovir (manufacturer unknown) 800mg/twice a daily and prednisone (manufacturer unknown). The patent did not performed lab diagnostics. The outcome of the patient developed the shingles after receiving ZOSTAVAX was reported as not recovered/not resolved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Headache, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Developed fever, tingling in extremities, bad headache, pain in both arms, pain over injection site and dizziness.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Developed fever, tingling in extremities, bad headache, pain in both arms, pain over injection site and dizziness.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Dull aching pain started evening after flu shot in left arm. Continued for a week then started to subside in second week. Patient noticed weakness in his arm while lifting weights. Pain continued on and off while at rest for several more weeks. Now pain mainly gone but had dull ache last night 12/9/13 again. No previous adverse reaction to a flu shot.
Age: 0.41
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Condition aggravated, Diet refusal, Gastrooesophageal reflux disease, Insomnia, Pain
Clinical narrative: Son screamed in pain for 5 days. Day 1: Screamed 24 hrs straight without sleeping. Refused to eat for 2 days. Exacerbated severe GERD symptoms, vomiting, fever 101 degrees F.
Age: 0.41
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Pyrexia, Screaming, Vomiting
Clinical narrative: Son screamed in pain for 5 days. Day 1: Screamed 24 hrs straight without sleeping. Refused to eat for 2 days. Exacerbated severe GERD symptoms, vomiting, fever 101 degrees F.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Eye swelling, Fatigue, Headache, Lacrimation increased
Clinical narrative: Appy 8 hrs after receiving vaccination felt very tired eyes tearing and swollen. Developed terrible headache, fever, chills and body aches. Took Ibuprofen 400 mg Q 6 h. Also c/o both hands stiff and "dry heaves".
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pain, Pyrexia, Retching
Clinical narrative: Appy 8 hrs after receiving vaccination felt very tired eyes tearing and swollen. Developed terrible headache, fever, chills and body aches. Took Ibuprofen 400 mg Q 6 h. Also c/o both hands stiff and "dry heaves".
Age: 47.0
Sex: M
Vaccine: FLUC3, TDAP
Symptoms: Cough, Oropharyngeal pain, Swollen tongue, Tongue blistering
Clinical narrative: Pt reported swollen tongue with blisters, sore throat, cough. Pt took Benadryl and symptoms resolved.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Vaccination site reaction
Clinical narrative: Pt w/vesicular eruptions at the vaccine site - seen on 12/7/13 VALTREX started on 12/9/13..
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Decreased appetite, Diarrhoea, Impaired work ability
Clinical narrative: Sniffles, sore throat, loose stools, body aches, back pain, loss of appetite, fever, weakness, unable to work for 3 days, stayed in bed for 3 days, and upon my research the flu shot contains gelatin a product of pork, which I do not eat pork.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Sniffles, sore throat, loose stools, body aches, back pain, loss of appetite, fever, weakness, unable to work for 3 days, stayed in bed for 3 days, and upon my research the flu shot contains gelatin a product of pork, which I do not eat pork.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Was diagnosed with shingles in eye 11/26/13.
Age: 21.0
Sex: F
Vaccine: FLUC3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.7
Sex: M
Vaccine: HIBV
Symptoms: Condition aggravated, Diet refusal, Gastrooesophageal reflux disease, Insomnia, Psychomotor hyperactivity
Clinical narrative: Effects lasted 6 days. Day 1: extremely drowsy, refused foods. Day 2: awake for 24 straight hrs, extreme hyperactivity. Refused food. Screamed for long periods of time. Day 3-6: exacerbated reflux symptoms. Refused most meals. Lost 1 pound. Requesting medical exemption document for immunizations due to two separate adverse reactions.
Age: 0.7
Sex: M
Vaccine: HIBV
Symptoms: Screaming, Somnolence, Weight decreased
Clinical narrative: Effects lasted 6 days. Day 1: extremely drowsy, refused foods. Day 2: awake for 24 straight hrs, extreme hyperactivity. Refused food. Screamed for long periods of time. Day 3-6: exacerbated reflux symptoms. Refused most meals. Lost 1 pound. Requesting medical exemption document for immunizations due to two separate adverse reactions.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Left deltoid and shoulder pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUX
Symptoms: Convulsion, Drug administered at inappropriate site, Intensive care
Clinical narrative: This case was reported by a consumer (subject's mother) and described the occurrence of seizure in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline), Influenza vaccine unspecified. A physician or other health care professional has not verified this report. Historic vaccination included diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined; manufacturer unspecified; manufacturer unspecified; unknown; unknown given on an unspecified date. Concurrent medications included CHILDREN'S TYLENOL, Multivitamin + fluoride and Fiber Well chew gummy. On 6 December 2013 at 11:00 the subject received a dose of KINRIX (unknown, unknown thigh) as the 5th dose in the DTAP and 4th in the polio series and a dose of Influenza vaccine unspecified (unknown), brand name was unknown. On 6 December 2013, at the time of vaccination with KINRIX, the subject experienced vaccine administered at inappropriate site. The mother of the subject reported that KINRIX was administered in either the right or left leg. The preferred site of administration for KINRIX is the deltoid muscle of the upper arm. On 7 December 2013, 17 hours after vaccination with Influenza vaccine unspecified and KINRIX, the subject experienced sustaining seizure. The subject had previous DTAP vaccines similar to PEDIARIX; this was the first time the subject received KINRIX. The subject was given ATIVAN intravenously and sent to the pediatric ICU (intensive care unit) and admitted to the hospital. The mother was unsure if the subject will have another seizure, at the time of the report she was no longer having a seizure. On 7 December 2013, the seizure was resolved.
Age: 0.2
Sex: U
Vaccine: RV1
Symptoms: Colon operation, Gastrointestinal disorder, Intussusception
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of intussusception in a 2-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). In November 2013 the subject received 1st dose of ROTARIX (1 ml, oral). In November 2013, 6 days after vaccination with ROTARIX, the subject experienced intussusception and GI side effects. The sales representative reported on behalf of the physician that the subject received ROTARIX on an unknown date around 18 or 19 November 2013, exact date was unknown. In November 2013, six days after receiving ROTARIX the subject had GI side effects, (details not provided) and intussusception. The subject was therefore admitted to the hospital (length of stay was unknown) "where some type of colon surgery was performed. As a result of the surgery, the subject is now doing better". The ROTARIX series has likely been discontinued but the reporting sales representative was unsure about this. It was reported that the physician's office reported this occurrence to the CDC. At the time of reporting the intussusception and GI side effects were improved. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). The physician considered the events were probably related to vaccination with ROTARIX.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Condition aggravated, Cytomegalovirus infection, Intraocular pressure test normal, Viral uveitis, Vision blurred
Clinical narrative: This case was reported by a consumer and described the occurrence of cytomegalovirus in a 50-year-old male subject who was vaccinated with Influenza vaccine unspecified (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included glaucoma surgery. Historic medical conditions included cytomegalovirus and uveitis. Concurrent medications included Lisinopril, Simvastatin, Glaucoma eye drops (unspecified) and Anti-inflammatory. On 21 October 2013 at 14:00 the subject received a dose of Influenza vaccine unspecified (unknown, left arm). On 22 October 2013, 1 day after vaccination with Influenza vaccine unspecified, the subject experienced "CMV uveitis" and blurred vision. The patient reported the physician confirmed that the subject does not have elevated eye pressure. This case was assessed as medically serious by GSK. At the time of reporting the cytomegalovirus, uveitis and blurred vision were improved.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Biopsy skin abnormal, Hypersensitivity, Pruritus, Rash generalised
Clinical narrative: Generalized rash with itching onset approximately early November 2013. Treatment included Antihistamine BID, 12 day course of Prednisone, topical steroid.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Nauseated on and off for days.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Haemorrhagic stroke, Nuclear magnetic resonance imaging
Clinical narrative: Massive hemorrhagic stroke.
Age: 53.0
Sex: F
Vaccine: FLUX, TTOX
Symptoms: Chills, Erythema, Formication, Headache, Hyperhidrosis
Clinical narrative: 12/13/13 I had flu shot in left arm and Tetanus in right arm. 12/14/13 Woke up at 5am with severe chills, fever, severe headache, pain in both arms. Pain, redness, and swelling in left arm (Tetanus). Chills subsided after Tylenol and a few hours. Low grade fever all day and headache. 12/15/13 Woke up 5:30 am Sunday severe headache, nausea, pain, redness, and swelling in left arm (Tetanus). Took Tylenol, iced arm, stayed in bed till noon. Headache and nausea subsided for a while and I had to take Tylenol and a VICODIN twice during the day for the pain. Iced my arm several times. 12/16/13 Woke up 5:00 am with chills sweats and feel headache and low fever. My arm is now all red where the tetanus shot was but some swelling gone down. However, my arm itches and I itch all over, no signs of rash. My skin is crawling. I emailed my Doctor. Waiting to here what if anything I can do. I am at work today (12/16/13).
Age: 53.0
Sex: F
Vaccine: FLUX, TTOX
Symptoms: Local swelling, Nausea, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: 12/13/13 I had flu shot in left arm and Tetanus in right arm. 12/14/13 Woke up at 5am with severe chills, fever, severe headache, pain in both arms. Pain, redness, and swelling in left arm (Tetanus). Chills subsided after Tylenol and a few hours. Low grade fever all day and headache. 12/15/13 Woke up 5:30 am Sunday severe headache, nausea, pain, redness, and swelling in left arm (Tetanus). Took Tylenol, iced arm, stayed in bed till noon. Headache and nausea subsided for a while and I had to take Tylenol and a VICODIN twice during the day for the pain. Iced my arm several times. 12/16/13 Woke up 5:00 am with chills sweats and feel headache and low fever. My arm is now all red where the tetanus shot was but some swelling gone down. However, my arm itches and I itch all over, no signs of rash. My skin is crawling. I emailed my Doctor. Waiting to here what if anything I can do. I am at work today (12/16/13).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Heart rate increased, Hypertension, Rash macular, Swollen tongue
Clinical narrative: Swelling of the tongue, rapid heartbeat, shortness of breath, blotchy face, high blood pressure.  Symptoms lasted about a week and gradually resolved.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: 3x3 area of redness with heat to site. Once redness went away, a small bruise was left. There were no other complaints or reactions.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site nerve damage, Injection site pain
Clinical narrative: Severe soreness inside the arm where the needle penetrated. Difficulty raising arm over my head or sleeping on it without sharp pain. Pain has been present for now over 2 months. Feels like a nerve issue.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: THE AREA OF INJECTION SITE BECAME RAISED, HOT AND TENDER TO TOUCH. THE PATIENT DESCRIBED THE AREA MEASURING ABOUT 7 INCH. SHE TOOK MOTRIN TO HELP WITH THE DISCOMFORT AND I ALSO RECOMMMENDED PUTTING ICE ON THE AREA. SHE DID NOT EXPERIENCED ANY DIFFICULTY BREATHING OR RASH.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site swelling, Nausea, Pain
Clinical narrative: AFTER THE SHOT, SHE DEVELOPED NAUSEA, BUT NO VOMITING. THEN PATIENT DEVELOPED BODY ACHES. ALSO DEVELOPED SWELLING AT THE INJECTION SITE. BODY ACHES, NAUSEA AND HEADACHE AT TIME OF ER VISIT (3-4 DAYS AFTER VACCINE). IMPROVED WITH BENADRYL/PAIN/NAUSEA MEDS.
Age: 1.15
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray, Convulsion, Culture urine, Irritability, Poor quality sleep
Clinical narrative: Extremely fussy/restless all nite 12/3 (vaccine given that afternoon), refused to nap 12/5, awoke 12/6 am "roasting" with fever, had seizure at 130PM, ER discharge 530PM, had 2nd seizure 830PM, different ER, admitted overnight for testing/fever reducing medication.
Age: 1.15
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Ultrasound kidney
Clinical narrative: Extremely fussy/restless all nite 12/3 (vaccine given that afternoon), refused to nap 12/5, awoke 12/6 am "roasting" with fever, had seizure at 130PM, ER discharge 530PM, had 2nd seizure 830PM, different ER, admitted overnight for testing/fever reducing medication.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Dry eye, Dry mouth, Electromyogram, Hyperhidrosis
Clinical narrative: Tingling/numbness in fingers & toes of both hands, feet and face.  Patchy sensation on trunk.  Burning sensation in hands, sweating, dryness in mouth and eyes.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: Tingling/numbness in fingers & toes of both hands, feet and face.  Patchy sensation on trunk.  Burning sensation in hands, sweating, dryness in mouth and eyes.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: Arm swelling.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Arm reaction - red, swollen, hot.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Contusion, Erythema, Pain, Pruritus
Clinical narrative: Arm reaction - red, itchy and bruised on 9/30, same night, fever, chills, and achy (15 mm).
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Arm reaction - red, itchy and bruised on 9/30, same night, fever, chills, and achy (15 mm).
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Gastrointestinal disorder, Pain
Clinical narrative: G.I. symptoms, achy and "bronchitis-like" for 3 weeks.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: Received influenza vaccine at 2 PM came back to clinic via triage RN at 4:50 PM. C/O rash on bilateral upper arms. Rash is itchy - vaccine given rt upper deltoid. No other SX. Suggest use of Benadryl as directed by manufacturer and 24 hr antihistamine product two days.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Pyrexia
Clinical narrative: Child's guardian (grandfather) called stating child had 2 seizures and a fever of 101.7, since having flu shot yesterday (12-10-13). Tylenol brought fever down to 100.4. Grandfather stated child has history of Cerebral Palsy, Autism, and Seizures (last known seizure 2 yrs ago).
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician concerning to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that the patient was pregnant when she received the dose of VARIVAX (Merck) (date unknown). The last menstrual period and estimated delivery date were not known. The reporter stated that the vaccine was administered by another physician. No symptoms were reported. Additional information has been requested.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Localized erythema 10 x 15 cm with pruritus and mild pain. No vesicles. No fevers or chills. Resolved over 5 - 7 days.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 2 year old patient. On 15-APR-2003 the patient was vaccinated with M-M-R II (dose 1, route, dosage and lot number unknown). On 25-APR-2003 the patient was vaccinated with VARIVAX (merck) (dose 1, route, dosage and lot number unknown). The nurse reported the two vaccines were placed too close together. No adverse effects were reported. On 08-FEB-2005, the patient received the second dose of M-M-R II (dose 2, route, dosage and lot number unknown). This is one of two reports on the same reporter link (1312USA007099). Additional information has been requested.
Age: 1.03
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 month old patient, gender unknown. On 22-AUG-2001 the patient was vaccinated with M-M-R II HSA (dose 1, route, dosage and lot number unknown). On 01-AUG-2001 the patient was vaccinated with VARIVAX (dose 1, route, dosage and lot number unknown). The nurse reported the two vaccines were placed too close together. No adverse effects were reported. On 25-AUG-2004, the patient received the second dose of M-M-R II HSA (dose 2, route, dosage and lot number unknown), and on 12-AUG-2013 the second dose of VARIVAX (Merck) (dose 2, route, dosage and lot number unknown). This is one of two reports on the same reporter link (1312USA003821). Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: The patient felt dizziness come on about 10 minutes after administration of flu shot. Emergency personnel were called and he was taken away in ambulance for precautionary reasons.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 35.0
Sex: M
Vaccine: JEV1
Symptoms: Headache, Oropharyngeal pain, Urticaria
Clinical narrative: Patient noticed hives on legs and arms and abdomen. HA and sore throat. Patient was advised to see provider.
Age: 65.0
Sex: M
Vaccine: FLUC3
Symptoms: Asthenia, Chills, Hyperhidrosis, Pyrexia
Clinical narrative: Chills, perspiration, general weakness, probable fever.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Pruritus, Urticaria
Clinical narrative: 16 year old male who had flu shot today at 6pm to left deltoid and went home. While in shower pt began having diffuse pruritis c generalized urticaria as well as throat swelling. No dyspnea, wheeze or stridor. Mother medicated c Benadryl 25mg PO X2 and urticaria/pruritis has resolved. Pt still c noticeable swelling of throat when swallowing only. Pt has had flu vaccine last 6-7 years s any adverse/allergic effect.  Prednisone 40mg PO.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Convulsion, Erythema, Influenza virus test negative, Injection site swelling, Injection site warmth
Clinical narrative: Leg pain (2-3 days - caused patient to scream). Fever (103 F - not responsive to ibuprofen or acetaminophen). Convulsions (severe for 2 hours on the evening of 12/4; sporadic for 8 hours). Swollen, red and extremely warm shot site (leg doubled in size; patient could not walk for 2 days).
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity, Pyrexia, Streptococcus test negative
Clinical narrative: Leg pain (2-3 days - caused patient to scream). Fever (103 F - not responsive to ibuprofen or acetaminophen). Convulsions (severe for 2 hours on the evening of 12/4; sporadic for 8 hours). Swollen, red and extremely warm shot site (leg doubled in size; patient could not walk for 2 days).
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Had immediate severe pain in arm with injection.  Pain continues with certain movements of the shoulder.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Nausea
Clinical narrative: Weakness, nausea, extreme fatigue. Patient reported that most symptoms subsided by 12/09/2013 evening.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Tendonitis
Clinical narrative: Pain at time of injection. Was informed needle hit bone. Very sore after. Pain continued to worsen until arm was unusable. Went to dr 12/16/2013 and treated for tendinitis due to injection given in the wrong place.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: Patient was admitted to hospital on 12/12/2013 as a transfer from an outside hospital with intussusception.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pruritus, Rash, Urticaria
Clinical narrative: Pt complained about onset of severe pain 4 hour from the time of vaccine administration. As per patient, she got hives and rash after 2 days. Rash remained even after 6 days. Patient also complained about itching. Patient has only allergy to penicillin. Patient required multiple doctor visits. MD does not believe symptoms were from the vaccine and reports as a co-incidence. Patient was treated with multiple creams such as clobetasol and clindamycin. Patient reports almost complete relief of symptoms as of 12/13/2013.
Age: 1.26
Sex: M
Vaccine: HIBV, MMR
Symptoms: Pyrexia, Rash generalised, Vomiting
Clinical narrative: Fever of 102.1, throwing up twice. Fever lasted for 3 days ranged from 102 to 104. Rash all over body and forehead. Tylenol and Advil every 4 hours while fever was present.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Muscle swelling, Pyrexia, Skin warm, Tenderness
Clinical narrative: Swollen elbow and lower biceps. Very painful to light touch and hot.  Had high fever all day since.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Allergy test, Aphasia, Blood heavy metal test, Bruxism
Clinical narrative: My child's entire personality changed.  She became upset with routine change, she began waking up in the middle of the night complaining that her ears hurt (while she still had language), she hardly slept anymore, she began to look depressed. She didn't recognize anyone (not even her own mother), she didn't talk anymore, she began banging things together like a child of a few months old.  She had no eye contact left, no happiness, did not want to eat any food or drink, she became clumsy, walked on her toes, began spinning, grinding her teeth.  She no longer had interest in people, toys, going outside. There was nothing left of who she was for the last two years.  This was a child who previously spoke in full sentences and had a very large vocabulary.  She used to wake up in the morning look for me and tell me she loved me.  Then she did not know who I was or that I even existed anymore.  She became so hyper, unfocused and then would want to just stay in her room.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Change in sustained attention, Clumsiness, Decreased appetite, Decreased eye contact, Decreased interest
Clinical narrative: My child's entire personality changed.  She became upset with routine change, she began waking up in the middle of the night complaining that her ears hurt (while she still had language), she hardly slept anymore, she began to look depressed. She didn't recognize anyone (not even her own mother), she didn't talk anymore, she began banging things together like a child of a few months old.  She had no eye contact left, no happiness, did not want to eat any food or drink, she became clumsy, walked on her toes, began spinning, grinding her teeth.  She no longer had interest in people, toys, going outside. There was nothing left of who she was for the last two years.  This was a child who previously spoke in full sentences and had a very large vocabulary.  She used to wake up in the morning look for me and tell me she loved me.  Then she did not know who I was or that I even existed anymore.  She became so hyper, unfocused and then would want to just stay in her room.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Depression, Ear pain, Emotional distress, Insomnia, Middle insomnia
Clinical narrative: My child's entire personality changed.  She became upset with routine change, she began waking up in the middle of the night complaining that her ears hurt (while she still had language), she hardly slept anymore, she began to look depressed. She didn't recognize anyone (not even her own mother), she didn't talk anymore, she began banging things together like a child of a few months old.  She had no eye contact left, no happiness, did not want to eat any food or drink, she became clumsy, walked on her toes, began spinning, grinding her teeth.  She no longer had interest in people, toys, going outside. There was nothing left of who she was for the last two years.  This was a child who previously spoke in full sentences and had a very large vocabulary.  She used to wake up in the morning look for me and tell me she loved me.  Then she did not know who I was or that I even existed anymore.  She became so hyper, unfocused and then would want to just stay in her room.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Personality change, Thyroid function test, Toe walking
Clinical narrative: My child's entire personality changed.  She became upset with routine change, she began waking up in the middle of the night complaining that her ears hurt (while she still had language), she hardly slept anymore, she began to look depressed. She didn't recognize anyone (not even her own mother), she didn't talk anymore, she began banging things together like a child of a few months old.  She had no eye contact left, no happiness, did not want to eat any food or drink, she became clumsy, walked on her toes, began spinning, grinding her teeth.  She no longer had interest in people, toys, going outside. There was nothing left of who she was for the last two years.  This was a child who previously spoke in full sentences and had a very large vocabulary.  She used to wake up in the morning look for me and tell me she loved me.  Then she did not know who I was or that I even existed anymore.  She became so hyper, unfocused and then would want to just stay in her room.
Age: 40.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Erythema, Feeling hot, Pain, Swelling, Tenderness
Clinical narrative: Redness, swelling, pain, hot, tender.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Vaccine given Thu 12/5, afternoon; on Saturday evening, patient noticed injection site was red, warm to the touch and tender. Sx persisted on Sunday 12/8. By Monday 12/9 AM, sx improved - really could not see any redness and only slightly warm to the touch and not as tender. As of Tuesday 12/10, 5:30PM, - redness gone, maybe only slightly discolored, no warmth or tenderness anymore.
Age: 75.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Neck stiffness, fever, pain in arm from elbow to site of injection.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Swelling
Clinical narrative: Pt presented with swollen left biceps and chest area. Area was warm to the touch and spreading down arm. Started approx 1" below injection site and ended at elbow.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injection site erythema, Injection site reaction, Injection site swelling, Nausea
Clinical narrative: Pt received PNEUMOVAX at approx 830 AM Thursday 12/12/13. Pt reports welts, redness, swelling at injection site - (L) deltoid. As well as nausea, diarrhea, subjective fever x 2-3 days, resolving spontaneously.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Pt received PNEUMOVAX at approx 830 AM Thursday 12/12/13. Pt reports welts, redness, swelling at injection site - (L) deltoid. As well as nausea, diarrhea, subjective fever x 2-3 days, resolving spontaneously.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injection site erythema, Injection site swelling, Nuclear magnetic resonance imaging brain normal
Clinical narrative: The first reaction was to the site of injection, which I understand is common to be red, but 3 or 4 days my under arm was swollen almost to my elbow. The pharmacist said it should subside usually around 5 days. The reaction to my arm did subside around 10-19-13. On 10-20, 10-21-13 I started having problems with numbness of my tongue, mouth, upper and lower lips, and facial numbness around my chin. I saw my PCP on 10-24-13, the only thing he could see was a few patches on the back of my tongue which resembled thrush, so he gave me a prescription for lozengers. I went back to him on 11-1-13, the patches were gone, but I still had all of the numbness, plus he noticed I was having an issue with my eye focusing looking to the left. So he ordered an MRI of the brain to rule out a stroke, and also an ultrasound of my carotid arteries on 11-06-13. MRI showed no strokes and ultrasound was good. So he recommended seeing a neurologist for a second opinion. I saw a neurologist on 11-18-13, she ordered a LP to rule out MS, but before the procedure could be done all my symptoms subsided, and I have not had any more symptoms. I had a follow up visit with my neurologist on 12-11-13, and in her medical opinion she believes that I had an adverse reaction to the ZOSTAVAX vaccine.