chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncopal event within about 10 min of administration of GARDASIL.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Discomfort, Erythema, Pruritus, Skin warm
Clinical narrative: Right arm redness, warmth, discomfort, and mild pruritis. No constitutional symptoms. IBU 200mg three times daily - BENADRYL 12.5mg three times daily PRN - Ice area x 15 mins 3-4 times daily - F/U PRN.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Blood amylase, Facial pain, Parotitis, Swelling face
Clinical narrative: Parotitis. Left side facial pain and swelling.
Age: 1.03
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site rash, Rash, Rash erythematous, Rash generalised
Clinical narrative: On 4-13-11 pt got rash on stomach & upper thighs, reddish pinhead raised, on 4-17 had spread to entire body and was very itchy, esp around diaper area.
Age: 1.03
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash pruritic
Clinical narrative: On 4-13-11 pt got rash on stomach & upper thighs, reddish pinhead raised, on 4-17 had spread to entire body and was very itchy, esp around diaper area.
Age: 0.21
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Body temperature increased, Irritability
Clinical narrative: Elevated temperature. Extreme irritability. IV Ampicillin. IV CLAFORAN.
Age: 0.4
Sex: M
Vaccine: RV1
Symptoms: Intussusception
Clinical narrative: This case was reported by a regulatory authority via Merck and described the occurrence of intussusception in a 20-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included ROTARIX ;GlaxoSmithKline;unknown given on an unspecified date at 8 weeks old. On an unspecified date the subject received 2nd dose of ROTARIX (unknown). On an unspecified date, eight days after vaccination with ROTARIX, the subject experienced intussusception. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the intussusception was unspecified. This is one of six cases reported by Merck, for the other five cases see A0901068A - A0901072A.
Age: 4.0
Sex: M
Vaccine: PNC13, DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: (R) shoulder swelling with KINRIX vaccine.
Age: 4.0
Sex: M
Vaccine: PNC13, DTAPIPV
Symptoms: Vaccination site swelling
Clinical narrative: (R) shoulder swelling with KINRIX vaccine.
Age: 0.12
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1, RV1, DTAP, HEP, HIBV, IPV, PPV, RV1
Symptoms: Intussusception, Surgery
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of intussusception in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced intussusception. The sales representative stated that the physician reported the subject experienced intussusception after taking ROTARIX sometime after November 2010, but could not remember the gender, initials or any other details regarding the subject. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the intussusception was unspecified. This is the second of three cases reported by the sales representative. For the other cases see A0911009A and A0911213A. Follow-up information was received on 17 February 2011 via physician who reported the 5-month-old female subject who was vaccinated with 1st dose of ROTARIX on 7 October 2010 and the 2nd dose 16 November 2010. Previous and/or concurrent vaccination included HIB; manufacturer unspecified; unknown; unknown given on 7 October 2010 and 16 November 2010; DTaP; manufacturer unspecified; unknown; unknown given on 7 October 2010 and 16 November 2010; Hepatitis B vaccine; manufacturer unspecified; unknown; unknown given on 25 August 2010 and 7 October 2010; Pneumococcal vaccines (non-gsk); manufacturer unspecified; unknown; unknown given on 7 October 2010 and 16 November 2010; poliomyelitis vaccine (non-gsk); manufacturer unspecified; unknown; unknown given on 7 October 2010 and 16 November 2010. On 30 December 2010, 34 days after the 2nd vaccination with ROTARIX, 74 days after the 1st vaccination with ROTARIX, the subject experienced intussusception. The subject had plain abdominal radiograph showing a visible intussusceptum, fluid levels and dilated bowel loops and demonstrated invagination of the intestine by air or liquid contrast enema. Abdominal ultrasound showed a visible intussuscetpum. The subject underwent "laparotomy reduction of ileocalie for intussusception after failure of barium enema reduction" on 30 December 2010. The subject's intussusception required surgical reduction but no resection. The physician considered the event was clinically significant (or requiring intervention). On 30 December 2010, the intussusception was resolved.
Age: 0.12
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1, RV1, DTAP, HEP, HIBV, IPV, PPV, RV1
Symptoms: Abdominal X-ray, Barium enema abnormal, Enema administration, Intussusception, Laparotomy
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of intussusception in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced intussusception. The sales representative stated that the physician reported the subject experienced intussusception after taking ROTARIX sometime after November 2010, but could not remember the gender, initials or any other details regarding the subject. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the intussusception was unspecified. This is the second of three cases reported by the sales representative. For the other cases see A0911009A and A0911213A. Follow-up information was received on 17 February 2011 via physician who reported the 5-month-old female subject who was vaccinated with 1st dose of ROTARIX on 7 October 2010 and the 2nd dose 16 November 2010. Previous and/or concurrent vaccination included HIB; manufacturer unspecified; unknown; unknown given on 7 October 2010 and 16 November 2010; DTaP; manufacturer unspecified; unknown; unknown given on 7 October 2010 and 16 November 2010; Hepatitis B vaccine; manufacturer unspecified; unknown; unknown given on 25 August 2010 and 7 October 2010; Pneumococcal vaccines (non-gsk); manufacturer unspecified; unknown; unknown given on 7 October 2010 and 16 November 2010; poliomyelitis vaccine (non-gsk); manufacturer unspecified; unknown; unknown given on 7 October 2010 and 16 November 2010. On 30 December 2010, 34 days after the 2nd vaccination with ROTARIX, 74 days after the 1st vaccination with ROTARIX, the subject experienced intussusception. The subject had plain abdominal radiograph showing a visible intussusceptum, fluid levels and dilated bowel loops and demonstrated invagination of the intestine by air or liquid contrast enema. Abdominal ultrasound showed a visible intussuscetpum. The subject underwent "laparotomy reduction of ileocalie for intussusception after failure of barium enema reduction" on 30 December 2010. The subject's intussusception required surgical reduction but no resection. The physician considered the event was clinically significant (or requiring intervention). On 30 December 2010, the intussusception was resolved.
Age: 0.12
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1, RV1, DTAP, HEP, HIBV, IPV, PPV, RV1
Symptoms: Small intestinal intussusception reduction, Ultrasound abdomen abnormal, X-ray abnormal
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of intussusception in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced intussusception. The sales representative stated that the physician reported the subject experienced intussusception after taking ROTARIX sometime after November 2010, but could not remember the gender, initials or any other details regarding the subject. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the intussusception was unspecified. This is the second of three cases reported by the sales representative. For the other cases see A0911009A and A0911213A. Follow-up information was received on 17 February 2011 via physician who reported the 5-month-old female subject who was vaccinated with 1st dose of ROTARIX on 7 October 2010 and the 2nd dose 16 November 2010. Previous and/or concurrent vaccination included HIB; manufacturer unspecified; unknown; unknown given on 7 October 2010 and 16 November 2010; DTaP; manufacturer unspecified; unknown; unknown given on 7 October 2010 and 16 November 2010; Hepatitis B vaccine; manufacturer unspecified; unknown; unknown given on 25 August 2010 and 7 October 2010; Pneumococcal vaccines (non-gsk); manufacturer unspecified; unknown; unknown given on 7 October 2010 and 16 November 2010; poliomyelitis vaccine (non-gsk); manufacturer unspecified; unknown; unknown given on 7 October 2010 and 16 November 2010. On 30 December 2010, 34 days after the 2nd vaccination with ROTARIX, 74 days after the 1st vaccination with ROTARIX, the subject experienced intussusception. The subject had plain abdominal radiograph showing a visible intussusceptum, fluid levels and dilated bowel loops and demonstrated invagination of the intestine by air or liquid contrast enema. Abdominal ultrasound showed a visible intussuscetpum. The subject underwent "laparotomy reduction of ileocalie for intussusception after failure of barium enema reduction" on 30 December 2010. The subject's intussusception required surgical reduction but no resection. The physician considered the event was clinically significant (or requiring intervention). On 30 December 2010, the intussusception was resolved.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC, VARCEL, DTAPIPV, MMR, PNC, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Cellulitis bilat. biceps. Erythema bilat biceps. Rx BACTRIM suspension, Hydrocortisone cream 2%.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site vesicles
Clinical narrative: Pt reported pain from Tdap, Tdap given in R Deltoid. Pt has blister at injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site of injection. 2 1/2 inches.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Ankylosing spondylitis, Diplopia, Migraine, Pain, Periorbital oedema
Clinical narrative: Severe peri-orbital edema, migraine headaches resulting in diplopia, blurred vision, and increased pain levels. Symptoms occured bilaterally, and have persisted greater than 5 months. The second shot was administered 12/16/10, and symptoms worsened. Treated in the ER and by primary care physician with a course of steroids, prednisone to decrease the peri-orbital edema. Additionally, ice packs for 10-15 min increments several times daily and ibuprofen up to 600-800mg every 6 hours.  Demerol was prescribed for pain management as well.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: Severe peri-orbital edema, migraine headaches resulting in diplopia, blurred vision, and increased pain levels. Symptoms occured bilaterally, and have persisted greater than 5 months. The second shot was administered 12/16/10, and symptoms worsened. Treated in the ER and by primary care physician with a course of steroids, prednisone to decrease the peri-orbital edema. Additionally, ice packs for 10-15 min increments several times daily and ibuprofen up to 600-800mg every 6 hours.  Demerol was prescribed for pain management as well.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Left leg hard and hot to touch. Skin with red blotches. Leg swollen.  Mother administered Tylenol and applied ice to affected area.
Age: 1.46
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Crying, Laboratory test normal, Pyrexia
Clinical narrative: High fever, seizure, inconsolable.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia oral, Lip swelling
Clinical narrative: About 8:30 AM on 4/26/11 sister of patient called health department. Stated patient's lips became swollen & numb at approx 3:30pm on 4/25/11. Able to swallow, breathe, no fever, n/v. No swelling/redness of injection site. Counseled to see private physician for further evaluation/treatment.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Infection, Injection site pruritus, Rash
Clinical narrative: A red "cold sore" like rash with some "blister like areas"  appeared on the back of his left arm where he received a varicella vaccination. Area covered a 3x2 inch patch. Pt c/o itching at the site. Client was seen by own MD Monday 4/25/11 afternoon.  Area was reportedly much improved and not as red.  MD dx area as an infection and gave antibiotic.  Parents of client are not convinced that rash was due to an infection, however, they still plan to give antibiotic, but wanted public health to know about reaction.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint swelling
Clinical narrative: The joints of her fingers, wrists and toes swelled and were painful.  This increased over the next couple of days then stared to resolve.
Age: 1.83
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Blood test normal, Convulsion, Diet refusal, Electroencephalogram, Foaming at mouth
Clinical narrative: She got her shots at 1:00 pm at Health Unit then went to taco Bell she didnt want to eat. We got home she took a 30-45 min. nap woke up layed there for 5 min. then went into a seizure. (the seizure happened on April 15th, 2011) She got her Hep. A shot at the Health Unit at 1:00 pm. After that we went to taco Bell she didn't eat. Then we went home and she took a 30-45 min. nap. She woke up from her nap and was fine for 5 min. She just layed there talking for 5 min. All of a sudden she got quiet. I (her mother) looked over at patient and she was in a seizure. I went to pick her up when her father ran to her and put her on her side he called 911. She had her eyes rolled back in her head and she was stiff and shaking and foaming from the mouth. That lasted for about 5-10 min by the time the ambulance got there she came out of seizure and was unresponsive. Took about 5 min to get her up. The ambulance took her. This all took place around 3:00 pm. The ER took blood and urine test and there was nothing wrong but a high fever of 103.9. The time of the shot (Hep A) she got at 1:00pm she did not have a fever. Only a runny nose. Health Unit did not take her temp. or any other vital signs before she got the shot. April 19th she had a Drs. apt. He sent us to get an EEG done of her. On April 21st, 2011, we are still waiting on the results of the test.
Age: 1.83
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Gaze palsy, Musculoskeletal stiffness, Pyrexia, Tremor, Unresponsive to stimuli
Clinical narrative: She got her shots at 1:00 pm at Health Unit then went to taco Bell she didnt want to eat. We got home she took a 30-45 min. nap woke up layed there for 5 min. then went into a seizure. (the seizure happened on April 15th, 2011) She got her Hep. A shot at the Health Unit at 1:00 pm. After that we went to taco Bell she didn't eat. Then we went home and she took a 30-45 min. nap. She woke up from her nap and was fine for 5 min. She just layed there talking for 5 min. All of a sudden she got quiet. I (her mother) looked over at patient and she was in a seizure. I went to pick her up when her father ran to her and put her on her side he called 911. She had her eyes rolled back in her head and she was stiff and shaking and foaming from the mouth. That lasted for about 5-10 min by the time the ambulance got there she came out of seizure and was unresponsive. Took about 5 min to get her up. The ambulance took her. This all took place around 3:00 pm. The ER took blood and urine test and there was nothing wrong but a high fever of 103.9. The time of the shot (Hep A) she got at 1:00pm she did not have a fever. Only a runny nose. Health Unit did not take her temp. or any other vital signs before she got the shot. April 19th she had a Drs. apt. He sent us to get an EEG done of her. On April 21st, 2011, we are still waiting on the results of the test.
Age: 1.83
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Urine analysis normal
Clinical narrative: She got her shots at 1:00 pm at Health Unit then went to taco Bell she didnt want to eat. We got home she took a 30-45 min. nap woke up layed there for 5 min. then went into a seizure. (the seizure happened on April 15th, 2011) She got her Hep. A shot at the Health Unit at 1:00 pm. After that we went to taco Bell she didn't eat. Then we went home and she took a 30-45 min. nap. She woke up from her nap and was fine for 5 min. She just layed there talking for 5 min. All of a sudden she got quiet. I (her mother) looked over at patient and she was in a seizure. I went to pick her up when her father ran to her and put her on her side he called 911. She had her eyes rolled back in her head and she was stiff and shaking and foaming from the mouth. That lasted for about 5-10 min by the time the ambulance got there she came out of seizure and was unresponsive. Took about 5 min to get her up. The ambulance took her. This all took place around 3:00 pm. The ER took blood and urine test and there was nothing wrong but a high fever of 103.9. The time of the shot (Hep A) she got at 1:00pm she did not have a fever. Only a runny nose. Health Unit did not take her temp. or any other vital signs before she got the shot. April 19th she had a Drs. apt. He sent us to get an EEG done of her. On April 21st, 2011, we are still waiting on the results of the test.
Age: 1.83
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Convulsion, Full blood count, Influenza virus test
Clinical narrative: She got her shots at 1:00 pm at Health Unit then went to taco Bell she didnt want to eat. We got home she took a 30-45 min. nap woke up layed there for 5 min. then went into a seizure. (the seizure happened on April 15th, 2011) She got her Hep. A shot at the Health Unit at 1:00 pm. After that we went to taco Bell she didn't eat. Then we went home and she took a 30-45 min. nap. She woke up from her nap and was fine for 5 min. She just layed there talking for 5 min. All of a sudden she got quiet. I (her mother) looked over at patient and she was in a seizure. I went to pick her up when her father ran to her and put her on her side he called 911. She had her eyes rolled back in her head and she was stiff and shaking and foaming from the mouth. That lasted for about 5-10 min by the time the ambulance got there she came out of seizure and was unresponsive. Took about 5 min to get her up. The ambulance took her. This all took place around 3:00 pm. The ER took blood and urine test and there was nothing wrong but a high fever of 103.9. The time of the shot (Hep A) she got at 1:00pm she did not have a fever. Only a runny nose. Health Unit did not take her temp. or any other vital signs before she got the shot. April 19th she had a Drs. apt. He sent us to get an EEG done of her. On April 21st, 2011, we are still waiting on the results of the test.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Severe pain in my right arm at and near the injection site. It hurts to move the arm - especially in certain positions such as reaching, pulling, pushing, putting behind my back. Physical Therapy 2x per week. Not due to vaccine, but to location of injection site.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Dyspnoea, Impaired driving ability, Laboratory test normal, Pain
Clinical narrative: Husband was hospitalized for cardiac problems. I went to pick him up - I collapsed in excruciating pain behind the wheel - I couldn't sit up to drive - had severe trouble breathing - pain was all around waist & middle of back - had to go to ER - collapsed on the floor.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Syncope
Clinical narrative: Husband was hospitalized for cardiac problems. I went to pick him up - I collapsed in excruciating pain behind the wheel - I couldn't sit up to drive - had severe trouble breathing - pain was all around waist & middle of back - had to go to ER - collapsed on the floor.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Cardiac disorder, Cardiac monitoring, Catheterisation cardiac, Myocarditis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient had cardiac symptoms the same night after taking the shot (10/21/10). He ended up at his cardiologist and was put in the hospital. On the special cardiac machines/equipment - he was having cardiac events for 5 days - he ended up w/ MRI and Myocarditis.
Age: 38.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Electromyogram, Grip strength decreased, Hypoaesthesia, Nerve conduction studies, Pain
Clinical narrative: Vaccine was administered on 2/3/11. There was no pain at time of injection. Pain in the right arm first began on 2/8/11. The shot was given on the Right arm - which has a shooting pain going down arm and into the hand. The hand has numbness and loss of grip.
Age: 38.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain in extremity, Ultrasound scan normal
Clinical narrative: Vaccine was administered on 2/3/11. There was no pain at time of injection. Pain in the right arm first began on 2/8/11. The shot was given on the Right arm - which has a shooting pain going down arm and into the hand. The hand has numbness and loss of grip.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Nuclear magnetic resonance imaging normal, Pain, Paraesthesia
Clinical narrative: Pt has had nerve pain in her right arm since the FLUVIRIN vaccine was administered. She describes the pain as shooting, tingling and throbbing. Pt has had an MRI evaluating her right arm, but no evidence of damage was seen. Arm appears visually normal.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Influenza A virus test positive, Lethargy, Pain, Pyrexia
Clinical narrative: Cough, fever, body aches, lethargy.
Age: 16.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pain, redness, swelling at injection site (L) deltoid. Had fever and headache 24 hrs post injection.
Age: 7.0
Sex: M
Vaccine: HIBV, PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Vaccine given on 4-15-11 in (R) thigh. On Sat mom called triage line & was advised to take child to ER for evaluation. Thigh swollen, painful, unable to put pressure on the leg. ER gave meds. Fever also present. Had 3 PCV7 vaccines previously.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Joint range of motion decreased, Pain in extremity, X-ray
Clinical narrative: Significant pain down (L) arm without erythema or edema and residual pain in shoulder jt itself & decreased ROM of (L) shoulder.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Continuous aching left arm and cannot lift arm. Began one week post IM injection.
Age: 41.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Dysentery
Clinical narrative: Dysentery x 4 days, approx 30 episodes.
Age: 20.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Fever, 20 cm x 10 cm very edematous erythemic tender, warm area on lower (R) deltoid muscle posterior more than anterior.
Age: 0.41
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Tremor, Vomiting
Clinical narrative: Pt. started vomiting after vaccines. Vomited several times then was shaking, no apnea. Recovered quickly. Later that evening increased vomiting and was admitted to local hospital.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Injection site erythema, Injection site pain, Rash generalised, Rash maculo-papular
Clinical narrative: Received Varicella vaccine on 4-4-11, 4-7-11 c/o red arm & tender at injection site. Called on 4/8/11 and stated arm was better. 4-9-11 Pt went to ER with residual rash all over body, itchy, macular papular per ER doctor. Rec'd BENADRYL in ER & sent home.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic
Clinical narrative: Received Varicella vaccine on 4-4-11, 4-7-11 c/o red arm & tender at injection site. Called on 4/8/11 and stated arm was better. 4-9-11 Pt went to ER with residual rash all over body, itchy, macular papular per ER doctor. Rec'd BENADRYL in ER & sent home.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Allergy to vaccine, Nasopharyngitis, Pruritus generalised, Rash, Urticaria
Clinical narrative: Mother called to report that on April 9 pt developed a "bad cold" on April 10 "welts & a rash" very itchy all over including hands & soles of feet. Took her to an osteopathic physician dx as allergic reaction to hep A vaccine given 4/7 no tx given.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Blood folate, Blood thyroid stimulating hormone, Candidiasis, Decreased appetite
Clinical narrative: Patient having sore throat, fatigue, abdominal pain, decreased appetite, fever for last 2 weeks onset on 4/7/11. Pt was given amoxicillin due to possible thought of infection. Pt developed thrush x 2 days after starting abx. Pt symptoms no improved with antibiotic. Pt family has history of having reactions to various vaccinations. Reactions to this vaccination rare but do include decreased appetite, fever, and abd. pain. Fever of 102.2 comes & goes.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Differential white blood cell count, Fatigue, Full blood count, Laboratory test, Liver function test
Clinical narrative: Patient having sore throat, fatigue, abdominal pain, decreased appetite, fever for last 2 weeks onset on 4/7/11. Pt was given amoxicillin due to possible thought of infection. Pt developed thrush x 2 days after starting abx. Pt symptoms no improved with antibiotic. Pt family has history of having reactions to various vaccinations. Reactions to this vaccination rare but do include decreased appetite, fever, and abd. pain. Fever of 102.2 comes & goes.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Oropharyngeal pain, Pyrexia, Urine analysis, Vitamin B12
Clinical narrative: Patient having sore throat, fatigue, abdominal pain, decreased appetite, fever for last 2 weeks onset on 4/7/11. Pt was given amoxicillin due to possible thought of infection. Pt developed thrush x 2 days after starting abx. Pt symptoms no improved with antibiotic. Pt family has history of having reactions to various vaccinations. Reactions to this vaccination rare but do include decreased appetite, fever, and abd. pain. Fever of 102.2 comes & goes.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: 10cm x 10 cm erythema & swelling.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Headache, Incoherent, Nausea, Pallor
Clinical narrative: Nausea, vomiting, pale, H/A, lightheadedness, incoherent.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, pale, H/A, lightheadedness, incoherent.
Age: 1.0
Sex: M
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised, Scab
Clinical narrative: Fever, with rash developing over the next 3 days.  Started on the head, covered the body over 3 days. Some crusted.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Patient received influenza vaccine intramuscularly in her left arm. She complained on one year later that she had been experiencing ongoing pain and weakness in her left arm since the vaccination. She continued to receive occupational therapy for this and prior back pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: Approximately 24 hours after adm. of PENTACEL developed 2 x 2.5 cm erythema.  No itching.  No induration of right deltoid area.  Not painful.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: No adverse event. Would like to report administration of inactive/expired/subtherapeutic vaccine. Lot # 0876Y had been deemed subtherapeutic by Merck in Nov 2010, expired 20Dec2010.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Developed a region of erythema and duration.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Cellulitis, Erythema, Headache, Nausea, Swelling
Clinical narrative: Red, swollen with welt.  C/o headache & some nausea.  Went to ER 4/21/11 in AM they gave her antibiotic (KEFLEX) & mother has been using ice packs for comfort.  ER advised it was cellulitis.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: Red, swollen with welt.  C/o headache & some nausea.  Went to ER 4/21/11 in AM they gave her antibiotic (KEFLEX) & mother has been using ice packs for comfort.  ER advised it was cellulitis.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Child complained of an itchy arm. Mom says arm in area of varicella vaccine is red, hot, itchy, swollen and is about "golf ball sized". Child has a history of allergies. No previous reactions to vaccines. Mom gave child BENADRYL & will give ice pack.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Lg red area to Lt deltoid 60 mm. Induration 40 mm. BENADRYL elixir. TYLENOL elixir.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: When patient was seen in our office on 4-16-2011, the parent stated child had uncontrollable crying and a red & swollen (L) leg following vaccine on 2-16-11.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash
Clinical narrative: Rash with mild severity and sudden onset since 1 day. - Use BENADRYL & hydrocortisone tx: will observe for now if worse to call & start ATB.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying
Clinical narrative: "Cried for 3-4 days. Nothing I could do would satisfy her" per mom.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Erythema, Feeling hot, Rash, Swelling
Clinical narrative: Swollen, hot, red, looks like rash.
Age: 0.35
Sex: M
Vaccine: HIBV, PNC, RV5
Symptoms: Body temperature increased, Diarrhoea
Clinical narrative: Elevated temperature persistent with diarrhoea on the day of immunization.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chest X-ray normal, Conjunctivitis infective, Headache, Vomiting
Clinical narrative: Went to ER with temp 104 degrees - severe headache and vomiting. All began morning of 4-16-11 - stated E.R. physician thought pneumonia but chest x-ray clear. Given bag of IV antibiotics.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: White blood cell count
Clinical narrative: Went to ER with temp 104 degrees - severe headache and vomiting. All began morning of 4-16-11 - stated E.R. physician thought pneumonia but chest x-ray clear. Given bag of IV antibiotics.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: C-reactive protein normal, Differential white blood cell count normal, Full blood count normal, Petechiae, Platelet count normal
Clinical narrative: Petechia. Mom reports she noticed a dotted like rash on ride home from office. Called office advised to come back. Doctor examined, diagnosed, order lab work. Rash was gone in 2 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Petechia. Mom reports she noticed a dotted like rash on ride home from office. Called office advised to come back. Doctor examined, diagnosed, order lab work. Rash was gone in 2 days.
Age: 1.29
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: 1 week after vaccine child had high fever and seizure. Brought to hospital for care.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Chest discomfort, Dyspnoea, Immediate post-injection reaction, Pallor
Clinical narrative: Immediately after Tdap injection patient gasp for breath & grabbed chest - face was pale - BP 140/80 at 955 AM. Gave sugar & patient laid down. BP 136/76, pulse 80 at 10 AM. BP 124/66, pulse 72 at 10:10 AM - discharged to home at 1030 with BP 110/66 pulse 72 - patient states felt like he has asthma attack.
Age: 11.0
Sex: F
Vaccine: DTAP, MNQ, TDAP, VARCEL
Symptoms: Overdose, Wrong drug administered
Clinical narrative: Wrong vaccine administered. Overdose of DTaP.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Injection site urticaria, Throat tightness, Urticaria
Clinical narrative: Coughing, Hives near injection site and then spread to chest, back and right arm, Throat Tightening.  Epi pen administered at 1:42 PM.
Age: 1.32
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: Following vaccines patient had "high fever and heart beating fast" per patient grandmother.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Fatigue, Injection site swelling
Clinical narrative: Sx. chills, fatigue, Lt. arm swollen from elbow to shoulder. OTC - ADVIL with effect, elevated (L) arm at HS with good effect. Pt. states she had PNEUMOVAX years ago without difficulty. Physical exam today with minimal finding of very faint erythema.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Computerised tomogram, Convulsion, Fall, Head injury, Loss of consciousness
Clinical narrative: Family reported that upon return to daycare after Dr's visit, pt developed high fever, had a seizure, fell & hit her head, stopped breathing and lost consciousness she was revived via CPR by staff & transported to ER via ambulance.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Respiratory arrest, Resuscitation
Clinical narrative: Family reported that upon return to daycare after Dr's visit, pt developed high fever, had a seizure, fell & hit her head, stopped breathing and lost consciousness she was revived via CPR by staff & transported to ER via ambulance.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Apr 14: 1 inch diameter bright red and raised area formed where shot was given. Temp 99.2, generalized achiness, chills, & fatigue. Apr 15: 2.25 inch diam. cherry red and indurated area at vaccine site. The site was approx. 1/4 inch raised. Temp 98.8 and site very painful & hot. Apr 16: 2.5 inch diameter maroon and even more indurated at site, hard and painful. Apr 17: redness subsided minimally. Apr 18: redness and induration minimally receded. Apr 19 - present: Sl. pink but palpable induration at vaccination site. I took pictures every day. Redness resolved however 3" diameter palpable "knot" persists.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site warmth, Nodule, Pain, Vaccination site induration
Clinical narrative: Apr 14: 1 inch diameter bright red and raised area formed where shot was given. Temp 99.2, generalized achiness, chills, & fatigue. Apr 15: 2.25 inch diam. cherry red and indurated area at vaccine site. The site was approx. 1/4 inch raised. Temp 98.8 and site very painful & hot. Apr 16: 2.5 inch diameter maroon and even more indurated at site, hard and painful. Apr 17: redness subsided minimally. Apr 18: redness and induration minimally receded. Apr 19 - present: Sl. pink but palpable induration at vaccination site. I took pictures every day. Redness resolved however 3" diameter palpable "knot" persists.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: IMMEDIATE SORENESS-LATER THAT DAY LARGE INDURATION ON L THIGH OF 5 INCHES. WARM TO TOUCH, SWOLLEN-LASTED 4 DAYS. PT VERY IRRITABLE AND EMOTIONAL.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Irritability
Clinical narrative: IMMEDIATE SORENESS-LATER THAT DAY LARGE INDURATION ON L THIGH OF 5 INCHES. WARM TO TOUCH, SWOLLEN-LASTED 4 DAYS. PT VERY IRRITABLE AND EMOTIONAL.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Chemotherapy, Condition aggravated, Hepatitis, Polymerase chain reaction, T-cell lymphoma
Clinical narrative: Vaccine-associated Varicella rash & Hepatitis-started chemo-therapy 8-30-2010, pt taking high dose Prednisone
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine, Varicella virus test positive
Clinical narrative: Vaccine-associated Varicella rash & Hepatitis-started chemo-therapy 8-30-2010, pt taking high dose Prednisone
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Axillary pain, Chest pain, Injection site pain, Limb immobilisation
Clinical narrative: Pain radiating way beyond injection site to armpit, chest, under arm, shoulder joint, etc.  Now, at 29 hrs. later the pain continues and is very severe.  Tylenol and immobilization provide minimal relief.  This is far from "normal" pain at the injection site.
Age: 2.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Pyrexia
Clinical narrative: fever of 103.0
Age: 40.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Asthenia, Fatigue
Clinical narrative: Patient recieved Tdap in LD IM and Flu vaccine in RD IM, uneventful. Four hours after the injections felt general weakness, loss of strength, no energy and felt tired. These symptoms lasted about 48hours. Symptoms improved 04/27/2011.
Age: 40.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Dizziness, Fatigue, Feeling cold, Muscular weakness, Somnolence
Clinical narrative: Patient recieved Tdap in LD IM and Flu vaccine in RD IM, uneventful. Four hours after the injections felt general weakness, loss of strength, no energy and felt tired. These symptoms lasted about 48hours. Symptoms improved 04/27/2011.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dysarthria, Dyspnoea
Clinical narrative: Shortness of Breath, B/P 70/42, Pulse 54, O2 sat 88%, slurred speech  IV started by ENT
Age: 1.66
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: High Fever 102.5 from 4-24-4/27/11. Rash all over body small bumps on 4/27/11.
Age: 15.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Chest pain, Dizziness, Dyspnoea
Clinical narrative: Difficlty breathing, Chest Pain, Dizziness  Patient was put on O2   IV started by ENT
Age: 1.04
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Blood test, Computerised tomogram head, Computerised tomogram normal, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy
Clinical narrative: Developed ITP (Idiothrombocytopenia) & URI like sxs. Admitted on 7/1/10 with platelet count of 4. Tx: CT, Blood wk, IV fluids, Ig given x 2 days along with BENADRYL & TYL.
Age: 1.04
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Platelet count decreased, Upper respiratory tract infection
Clinical narrative: Developed ITP (Idiothrombocytopenia) & URI like sxs. Admitted on 7/1/10 with platelet count of 4. Tx: CT, Blood wk, IV fluids, Ig given x 2 days along with BENADRYL & TYL.
Age: 18.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Hypoaesthesia, Joint swelling, Limb discomfort, Pain in extremity, Paraesthesia
Clinical narrative: Pain shooting down (R) arm & fingers hurting started 8pm 4-26-11, 4-27-11 morning noticed (R) hand cold & cold to touch, c/o knuckles swollen & can't bend to a fist w/o pressure & pain, c/o (R) palm tingling & (R) 3-5 fingers numb & tingling.
Age: 18.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Peripheral coldness
Clinical narrative: Pain shooting down (R) arm & fingers hurting started 8pm 4-26-11, 4-27-11 morning noticed (R) hand cold & cold to touch, c/o knuckles swollen & can't bend to a fist w/o pressure & pain, c/o (R) palm tingling & (R) 3-5 fingers numb & tingling.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Local swelling, Paraesthesia, Rash, Rash erythematous
Clinical narrative: Red rash at site of shot - went to chest, neck & face - tingling started 2 days after, neck swollen on side of body vaccine admin.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash maculo-papular, Rash vesicular, Skin lesion
Clinical narrative: Pt. dx with shingles on 4.26/11. She developed lesions about 1 week after vaccine - per MD. Maculopapulovesicular lesions on left arm & 3 isolated lesions foot.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site atrophy, Injection site mass, Injection site pain
Clinical narrative: Soreness in left upper arm never went away feels like I got the immunization today. A lump formed at the site, became bigger more painful over time. Unable to dress. Pain arm - saw chiropractor. "Pushed on lump", it dissipated, now a depression exists in its spot. 1" diameter and 1/2 " deep depression located 6" below acromium (L) upper arm.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Local swelling, Swelling face
Clinical narrative: Localized swelling and redness to immunization site. Patient reports some swelling of the face on 4/26/10.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Injection site induration, Injection site warmth, Laboratory test normal, Local reaction, Pyrexia
Clinical narrative: Large local reaction 3 1/2 x 2 1/2 inches in location of mid-left thigh. Warm to touch and indurated in the center. Low grade fever since it started.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Streptococcus test
Clinical narrative: Large local reaction 3 1/2 x 2 1/2 inches in location of mid-left thigh. Warm to touch and indurated in the center. Low grade fever since it started.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash macular
Clinical narrative: After vaccine given on 3/21/11 in Rt thigh redness with swelling x 2days. Now on 4/27/11 (+) blotchy redness with pain in area where injection given.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Flatulence, Irritability
Clinical narrative: 1/31/11 Baby was given immunizations. 2/2/11 Mom called clinic stating baby was throwing up with no appetite. 2/13/11 Baby was still throwing up. 2/4/11 Baby was screaming most of nite as if in pain - still throwing up also loose stools. 2/4/11 Baby was evaluated by his pediatrician. Diagnosis was possible adverse reaction to ROTATEQ vaccine. No fever but vomiting and diarrhea and belly cramping, gas and very irritable. Parents were told to continue to push fluids, slowly restart solids. Also try 3/4 tsp BENADRYL to help with histamine response and quiet his tummy. Also given an Rx for ZOFRAN prn for vomiting and nausea. Monitor for signs of dehydration.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Screaming, Vomiting
Clinical narrative: 1/31/11 Baby was given immunizations. 2/2/11 Mom called clinic stating baby was throwing up with no appetite. 2/13/11 Baby was still throwing up. 2/4/11 Baby was screaming most of nite as if in pain - still throwing up also loose stools. 2/4/11 Baby was evaluated by his pediatrician. Diagnosis was possible adverse reaction to ROTATEQ vaccine. No fever but vomiting and diarrhea and belly cramping, gas and very irritable. Parents were told to continue to push fluids, slowly restart solids. Also try 3/4 tsp BENADRYL to help with histamine response and quiet his tummy. Also given an Rx for ZOFRAN prn for vomiting and nausea. Monitor for signs of dehydration.
Age: 27.0
Sex: F
Vaccine: HEPAB
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of possible cellulitis in a 27-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous vaccination included 1st dose of TWINRIX (GlaxoSmithKline) given on an unspecified date. There were no concurrent medications. On the afternoon of 18 April 2011 the subject received a 2nd dose of TWINRIX at 1.0 ml in the left arm. On 18 April 2011, less than one day after vaccination with TWINRIX, the subject experienced injection site pain, injection site soreness, injection site warmth and swelling at the injection site. It was reported that the subject's arm was swollen. It was reported that the symptoms got worse overnight. The subject experienced difficulty moving her arm and the events were "limiting" her (activities of daily living impaired) but not considered to necessarily be "disabling." The subject went to see her physician and the physician suspected possible cellulitis or joint infections. He was planning to have the subject follow-up in two days. This case was assessed as medically serious by GSK. At the time of reporting the events were worse. It was noted that the subject did not have any reaction from the 1st dose of TWINRIX.
Age: 27.0
Sex: F
Vaccine: HEPAB
Symptoms: Oedema peripheral
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of possible cellulitis in a 27-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous vaccination included 1st dose of TWINRIX (GlaxoSmithKline) given on an unspecified date. There were no concurrent medications. On the afternoon of 18 April 2011 the subject received a 2nd dose of TWINRIX at 1.0 ml in the left arm. On 18 April 2011, less than one day after vaccination with TWINRIX, the subject experienced injection site pain, injection site soreness, injection site warmth and swelling at the injection site. It was reported that the subject's arm was swollen. It was reported that the symptoms got worse overnight. The subject experienced difficulty moving her arm and the events were "limiting" her (activities of daily living impaired) but not considered to necessarily be "disabling." The subject went to see her physician and the physician suspected possible cellulitis or joint infections. He was planning to have the subject follow-up in two days. This case was assessed as medically serious by GSK. At the time of reporting the events were worse. It was noted that the subject did not have any reaction from the 1st dose of TWINRIX.