chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Headache, Injected limb mobility decreased, Injection site erythema, Injection site induration
Clinical narrative: I started to have a head ache, back ache, and neck ache. I started to run a low grade fever the night of 05/21/10. By Saturday 05/22/10 I began to run a fever around 100 degrees. By Saturday night I ran a high fever of 103 with severe body pain and ache, which could not be resolved with over the counter meds. The site where I received the pneumonia vaccine was a hard, red, hot knot. I could barely move my arm and it is still sore. I continue to run a temp today, Monday 05/24/10. I have no illness symptoms except for body ache and fever.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Injection site nodule, Injection site warmth, Neck pain, Pain, Pain in extremity
Clinical narrative: I started to have a head ache, back ache, and neck ache. I started to run a low grade fever the night of 05/21/10. By Saturday 05/22/10 I began to run a fever around 100 degrees. By Saturday night I ran a high fever of 103 with severe body pain and ache, which could not be resolved with over the counter meds. The site where I received the pneumonia vaccine was a hard, red, hot knot. I could barely move my arm and it is still sore. I continue to run a temp today, Monday 05/24/10. I have no illness symptoms except for body ache and fever.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: I started to have a head ache, back ache, and neck ache. I started to run a low grade fever the night of 05/21/10. By Saturday 05/22/10 I began to run a fever around 100 degrees. By Saturday night I ran a high fever of 103 with severe body pain and ache, which could not be resolved with over the counter meds. The site where I received the pneumonia vaccine was a hard, red, hot knot. I could barely move my arm and it is still sore. I continue to run a temp today, Monday 05/24/10. I have no illness symptoms except for body ache and fever.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: - had shingles in past on the butt, re-appeared 4 days after shot. Both butt had shingles - improved since started.
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Facial palsy, Headache
Clinical narrative: Grandmother stated that he complained of a headache at 10 p.m. and she gave him 2 teaspoons of liquid Motrin and at 11:00 p.m. he could not smile on the right side of his face and his right eye would not close all the way. Seen at ER and his blood pressure and arms/legs were checked and the ER doctor diagnosed Bell's Palsy.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Blood test, Borrelia test, Computerised tomogram abnormal, Eye swelling, Eyelid disorder
Clinical narrative: -Stated "feeling like I  burnt my to tongue " 20 min. after I got my vaccine. - 9 hrs later around dinnertime L lower lip and tongue felt numb. 24 hrs later - L side of face/forehead to neck felt numb. -L eye feels swollen/not shutting eye lid.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: -Stated "feeling like I  burnt my to tongue " 20 min. after I got my vaccine. - 9 hrs later around dinnertime L lower lip and tongue felt numb. 24 hrs later - L side of face/forehead to neck felt numb. -L eye feels swollen/not shutting eye lid.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Patient reported hard lump and redness at injection site 2 days after administration.
Age: 1.05
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt developed diffuse urticaria about 5 minutes after vaccines given. Lungs clear, vitals stable, no swelling. BENADRYL 9mg given and resolved.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Abdominal pain upper, Anaemia, Dizziness, Electroencephalogram, Full blood count
Clinical narrative: Pt was given 2 shots on 4/15/10. One was varicella and one was HPV. Immediately after vaccination the pt got lightheaded so we sat her on the floor with head down and feet up until she felt better. She returned back to class that day. The next day (4/16/10) as she was in the lunch line at school her stomach began to hurt and she got dizzy. She went to tell her line teacher. As she got to her and began to tell her she wasn't feeling good she went down and the teacher caught her. She doesn't remember after that. She passed out and peed her pants. Her grandmother and mother were called in and she was taken to the Dr. where lab work was ordered. The found that she was anemic. All lab results will be with VAERS form. Description of incident per RN  administrator of vaccine and per pt mother per phone call.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Loss of consciousness, Urinary incontinence
Clinical narrative: Pt was given 2 shots on 4/15/10. One was varicella and one was HPV. Immediately after vaccination the pt got lightheaded so we sat her on the floor with head down and feet up until she felt better. She returned back to class that day. The next day (4/16/10) as she was in the lunch line at school her stomach began to hurt and she got dizzy. She went to tell her line teacher. As she got to her and began to tell her she wasn't feeling good she went down and the teacher caught her. She doesn't remember after that. She passed out and peed her pants. Her grandmother and mother were called in and she was taken to the Dr. where lab work was ordered. The found that she was anemic. All lab results will be with VAERS form. Description of incident per RN  administrator of vaccine and per pt mother per phone call.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Local Erythema 5cm x 3cm L thigh.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pruritus
Clinical narrative: 2 days post vaccination developed blisters on backside (site of previous infection) similar to shingles eruptions in past. Itching, but no pain, advised to go to urgent care for exam. Diagnosed with mild shingles, treated with famciclovir. Reports she has had shingles 4 times in past.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: This case was reported by a physician and described the occurrence of erythema in a 5-year-old subject of unspecified gender who was vaccinated with INFANRIX. On an unspecified date the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced erythema, tenderness, swelling and pharmaceutical product complaint. The subject's top part of thighs was red, tender and swollen for approximately three or four days. At the time of the report, no other details were provided. At the time of reporting the erythema, tenderness, and swelling were resolved. This is the second of three subjects the physician reported who experienced adverse events with INFANRIX within two to three weeks; see cases A0851205A and A0851211A. Follow-up information was received on 05 April 2010, via physician. The 5-year-old male subject who was vaccinated with 5th dose of INFANRIX (.5 ml, intramuscular, left thigh) on an unspecified date in 2010; lot number reported as "B091AA". The subject received four previous DTaps. No adverse events were reported with previous vaccinations. On "10 May 2010" at an unspecified time after vaccination with INFANRIX, the subject was diagnosed with a "large local reaction" and experienced more redness, swelling of the left thigh than usual reaction. The physician did not consider the events serious and were not associated with medical history/concurrent illness, lack of efficacy, erroneous administration, or suspected transmission. The physician reported the event onset date was "10 May 2010" and resoled "14 May 2010".
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Swelling, Tenderness
Clinical narrative: This case was reported by a physician and described the occurrence of erythema in a 5-year-old subject of unspecified gender who was vaccinated with INFANRIX. On an unspecified date the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced erythema, tenderness, swelling and pharmaceutical product complaint. The subject's top part of thighs was red, tender and swollen for approximately three or four days. At the time of the report, no other details were provided. At the time of reporting the erythema, tenderness, and swelling were resolved. This is the second of three subjects the physician reported who experienced adverse events with INFANRIX within two to three weeks; see cases A0851205A and A0851211A. Follow-up information was received on 05 April 2010, via physician. The 5-year-old male subject who was vaccinated with 5th dose of INFANRIX (.5 ml, intramuscular, left thigh) on an unspecified date in 2010; lot number reported as "B091AA". The subject received four previous DTaps. No adverse events were reported with previous vaccinations. On "10 May 2010" at an unspecified time after vaccination with INFANRIX, the subject was diagnosed with a "large local reaction" and experienced more redness, swelling of the left thigh than usual reaction. The physician did not consider the events serious and were not associated with medical history/concurrent illness, lack of efficacy, erroneous administration, or suspected transmission. The physician reported the event onset date was "10 May 2010" and resoled "14 May 2010".
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: This case was reported by a physician and described the occurrence of erythema in a 5-year-old subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX (unknown), lot number reported as "AC14B091". At an unspecified time after vaccination with INFANRIX, the subject experienced erythema, tenderness, swelling and pharmaceutical product complaint. The subject's top part of thighs was red, tender and swollen for approximately three or four days. At the time of the report, no other details were provided. At the time of reporting the erythema, tenderness, and swelling were resolved. This is the third of three subjects the physician reported who experienced adverse events with INFANRIX within two to three weeks; see cases A0851205A and A0851210A. Only lot number for subject 3 was available. Follow-up information was received on 05-April 2010, via physician. The 5-year-old male subject who was vaccinated with 5th dose of INFANRIX (.5 ml, intramuscular, left thigh) on an 23 March 2010; lot number reported as "B106CA". The subject received four previous DTaps. No adverse events were reported with previous vaccinations. Previous and/or concurrent vaccination included MMR vaccine (non-gsk); non-GSK manufacturer; subcutaneous; unknown given on 23 March 2010; IPOL (non-gsk); non-GSK manufacturer; intramuscular; unknown given on 23 March 2010. On 24 March 2010, 1 day after vaccination with INFANRIX, the subject was diagnosed with a "large local reaction" and experienced more redness, swelling of the left thigh than usual reaction. The physician did not consider the events serious and were not associated with medical history/ concurrent illness, lack of efficacy, erroneous administration, or suspected transmission. On 29 March 2010, the local reaction, erythema, tenderness, and swelling were resolved.
Sex: U
Vaccine: DTAP
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a pharmacist and described the occurrence of anaphylaxis in a subject of unspecified age and gender who was vaccinated with Dtpa, manufacturer unspecified, IPV, and MMR vaccine. The subject's medical history and concurrent medications were not provided. On an unspecified date the subject received an unspecified dose of Dtpa (unknown), an unspecified dose of IPV, and an unspecified dose of MMR vaccine. At an unspecified time after vaccination with Dtpa, IPV and MMR vaccine, the subject experienced anaphylaxis that required an emergency department visit. The pharmacist considered the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: DTAP, MMR
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a pharmacist and described the occurrence of anaphylaxis in a subject of unspecified age and gender who was vaccinated with DTAP (manufacturer unspecified), IPV, and MMR.  The subject's medical history and concurrent medications were not provided.  On an unspecified date the subject received an unspecified dose of DTAP (unknown), an unspecified date the subject received an unspecified dose of DTAP (unknown), an unspecified dose of IPV, and an unspecified dose of MMR vaccine.  At an unspecified time after vaccination with DTAP, IPV and MMR vaccine, the subject experienced anaphylaxis that required an emergency department visit.  The pharmacist considered the event was clinically significant (or requiring intervention).  At the time of reporting the outcome of the event was unspecified.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, PNC
Symptoms: Injection site reaction, Injection site swelling, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of local reaction at injection site in a 2-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), HAVRIX, (non-gsk) PREVNAR, FLUZONE (non-gsk). On 12 December 2008 the subject received 1st dose of INFANRIX (.5 ml, unknown), 2nd dose of HAVRIX (unknown), 4th dose of PREVNAR and unspecified dose of FLUZONE (Non-GSK). On 13 December 2008, a few hours after vaccination with HAVRIX, INFANRIX, PREVNAR and FLUZONE (Non-GSK), the subject experienced local reaction at injection site. At the injection site there was swelling and a rash around it. The physician wrote an unspecified prescription for the rash. In December 2008, the events were resolved. The healthcare professional considered the events were probably related to vaccination with INFANRIX, HAVRIX, PREVNAR and FLUZONE (Non-GSK).
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Oedema peripheral, Wrong drug administered
Clinical narrative: This case was reported by healthcare professional and described the occurrence of wrong vaccine administration in a 7-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject inadvertently received unspecified dose of INFANRIX (unknown). This was considered to be the wrong vaccine for administration. The child should not have received INFANRIX at the age of 7. At an unspecified time after vaccination with INFANRIX, the child developed a swollen arm. At the time or reporting the outcome of the event was unspecified.
Age: 1.37
Sex: F
Vaccine: DTAP
Symptoms: Biopsy, Inappropriate schedule of drug administration, Injection site papule, Injection site pruritus, Local reaction
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of bump at injection site for 8 months in a 2-year-old subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). In March 2009 2009 the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX time after vaccination with INFANRIX, the subject experienced bump at injection site for 8 months, a preliminary biopsy was positive for aluminum, possible allergy to aluminum, and drug dose administration interval too long. At the time of reporting  the outcome of the events was unspecified. On 16 October 2009, a physician reported via a sales representative that a subject experienced a bump at injection site for 8 months. The preliminary biopsy was positive for aluminum. The subject may have had an aluminum allergy. The date of injection was March 2009. This was a catch-up vaccine. The sales representative had no additional information to provide. The subject's bump at the injection site was also described as itchy. The subject was diagnostic with local allergic reaction. Follow up information was provided on 11 November 2009 via the vaccine responsible physician. On an unspecified date in March 2009, the subject received a fourth dose of INFANRIX (intramuscularly, right thigh). The physician reported the onset date of the previously reported events was on 15 May 2009, ,approximately two months after vaccination with INFANRIX. The physician reported the immunization series was delayed due to parent's choice. The physician reported that a biopsy was performed; however, the physician did not have the biopsy results since it was "done elsewhere". At the time of reporting, the outcome of the events was unresolved.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: (L) deltoid erythema, tender to touch; swelling.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Erythema, Sneezing
Clinical narrative: Sneezing, redness, & cough after immunizations given.  BENADRYL & EPI given.  Pt observed X 1 hr d/c home in stable condition.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Patient was fine the evening of the MMRV vaccine.  When he woke in the morning, he had a very slight fever and complained of his arm hurting.  His arm was red, warm and very swollen.  The redness spead from his elbow to his shoulder and started to go around his arm.  Tylenol helped with the slight fever and achiness.  Today, 05/24/2010, the arm is still slightly red and still has some swelling.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Culture urine positive, Escherichia infection, Full blood count normal, Haematuria, Proteinuria
Clinical narrative: Patient presented for evaluation on 5/18/2010. Generalized purpuric rash on the trunk and extremities. No mucocutaneous involvement. Low grade fever was present - 99.8 F. No thrombocytopenia. Microscopic hematuria, pyuria and proteinuria present on UA. Urine culture grew E. coli.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Purpura, Pyrexia, Pyuria, Rash generalised, Urine analysis abnormal
Clinical narrative: Patient presented for evaluation on 5/18/2010. Generalized purpuric rash on the trunk and extremities. No mucocutaneous involvement. Low grade fever was present - 99.8 F. No thrombocytopenia. Microscopic hematuria, pyuria and proteinuria present on UA. Urine culture grew E. coli.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever of around 100 degrees...   tired, quiet.
Age: 14.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Confusional state, Delusion, Depressed level of consciousness, Dizziness, Fatigue
Clinical narrative: Patient received his routine allergy shot and a Hep-A and Varicella shot at 9:45 a.m.  We waited the alloted thirty minutes to see if he had any reactions, was checked out by provider at 10:15 a.m.  Everything seemed to be in order and then we left.  As we headed out to the car, patient said he felt a bit light headed.  When we arrived at the car, he circled it and seemed confused as to what to do.  I sat him down in his seat and proceeded to drive home.  However, about half a mile down the road, he complained of being dizzy and thought there was something in the road when the road was empty.  I turned around and went back to the clinic. He was seen immediately by provider, who took his blood pressure, oxygen levels, and listened to his heart and lungs.  Patient's vitals were fine, other than being dizzy, light headed, confused, pale, and fatigued.  A pediatrician came in to check him out.  The doctor felt he was okay.  The doctor recommended I take him home, give him lots of fluids for the day and keep patient cool for the day.  Patient rested that day.  He was slow that day and pretty much for the weekend.  We made sure he drank plenty of fluids and stayed cool. He feels fine.  The injection site is still sore.
Age: 14.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site pain, Pallor
Clinical narrative: Patient received his routine allergy shot and a Hep-A and Varicella shot at 9:45 a.m.  We waited the alloted thirty minutes to see if he had any reactions, was checked out by provider at 10:15 a.m.  Everything seemed to be in order and then we left.  As we headed out to the car, patient said he felt a bit light headed.  When we arrived at the car, he circled it and seemed confused as to what to do.  I sat him down in his seat and proceeded to drive home.  However, about half a mile down the road, he complained of being dizzy and thought there was something in the road when the road was empty.  I turned around and went back to the clinic. He was seen immediately by provider, who took his blood pressure, oxygen levels, and listened to his heart and lungs.  Patient's vitals were fine, other than being dizzy, light headed, confused, pale, and fatigued.  A pediatrician came in to check him out.  The doctor felt he was okay.  The doctor recommended I take him home, give him lots of fluids for the day and keep patient cool for the day.  Patient rested that day.  He was slow that day and pretty much for the weekend.  We made sure he drank plenty of fluids and stayed cool. He feels fine.  The injection site is still sore.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Mother states child's upper left arm was starting to swell and was red. States child could move arm but complained of pain.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Arthralgia, Carpal tunnel syndrome, Pain in extremity
Clinical narrative: Right wrist pain that resolved.  On Sunday started to have left wrist pain.  Got worse.  Family called said having pain in arm due to shots.  Diagnosis carpal tunnel syndrome.  Patient finish large project for school and was typing a lot.
Age: 22.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Body aches shortly followed by severe headache, chills, and fever.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Nodule, Pain in extremity, Skin warm
Clinical narrative: Pt states right arm painful several hours after vaccine given.  Small knot, by the next day had a 25 cent size knot, red and hot to touch. Pt was out of town and came in 10 days later and advised us of reaction.  She had knot the size of nickel.  Pt advised if not better should make appt to have provider check.  Pt states she is in and out of town.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram normal, Fatigue, Full blood count normal
Clinical narrative: Approximately 10 minutes after receiving the MCV4 vaccination we left the Dr. office only to have my daughter say she didn't feel well and she passed out.  Her breathing was heavy until she came within a minute, but she was extremely tired afterwards and just rested the rest of the day.  2 weeks later on July 31, 2009 she had a major (Tonic-Clonic) type seizure, 4 weeks later on August 28, 2009 another seizure.  Since that time she has had 3 more seizures (March 24, 2010, April 26, 2010 and May 1, 2010) for a total of 5 as of this date.  Never had any health issues whatsoever until this vaccination was given!!!
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Grand mal convulsion, Hyperventilation, Loss of consciousness, Malaise
Clinical narrative: Approximately 10 minutes after receiving the MCV4 vaccination we left the Dr. office only to have my daughter say she didn't feel well and she passed out.  Her breathing was heavy until she came within a minute, but she was extremely tired afterwards and just rested the rest of the day.  2 weeks later on July 31, 2009 she had a major (Tonic-Clonic) type seizure, 4 weeks later on August 28, 2009 another seizure.  Since that time she has had 3 more seizures (March 24, 2010, April 26, 2010 and May 1, 2010) for a total of 5 as of this date.  Never had any health issues whatsoever until this vaccination was given!!!
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU(H1N1), FLU3, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Swollen, tender right deltoid, erythema.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: Vaccine given 5/18/2010, next day Pt developed an injection site reaction. She was concerned and so I'm filling out VAERS. Next day about 1 inch pink "rash" developed w/ fever x 2 days. Pt took BENADRYL. "Rash" increased slightly that day then subsided. Description from other pharmacist -> small pink area - not on injection site.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Ecchymosis, Idiopathic thrombocytopenic purpura
Clinical narrative: Developed bruising/ecchymoses on various parts of body. 5 days after Flu vaccination seen in my office 10/30/09, referred to a Hematologist, seen same day-Platelet count = 2. Dx: Acute ITP.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Body temperature increased, Erythema, Swelling
Clinical narrative: 4 in diam redness and swelling and 99.5 temp.
Sex: U
Vaccine: DTP
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: This case was reported by a physician and described the occurrence of injection site pain in an adult subject of unspecified gender who was vaccinated with DTP vaccine (GlaxoSmithKline). In September 2009 the subject received unspecified dose of DTP vaccine (unknown). On 29 September 2009, 8 days after vaccination with DTP vaccine,  the subject experienced injection site pain. The reporting physician was calling about an employee of his, who received a Tdap vaccine 9 days ago and developed slight pain at the injection site 8 days later. He did not know which brand of vaccine the subject received. At the time of reporting the event was unresolved. Follow up information was received on 19 October 2009 from the reporting physician. The physician reported that her PCP office recommended her to apply heat to the area and the swelling/redness was gone after two days. The initial reaction was noted only on post vaccine day eight and may not have been GlaxoSmithKline's product. The subject declined to provide information required to complete the adverse event report form. The physician reported that he was not the subject's primary care physician.
Sex: U
Vaccine: DTP
Symptoms: Radiculitis brachial
Clinical narrative: This case was reported by a healthcare professional via Merck and described the occurrence of brachial neuritis in a subject of unspecified age and gender who was vaccinated with DTP (manufacturer unspecified). On an unspecified date the subject received unspecified dose of TDaP (unknown). At an unspecified time after vaccination with DTaP vaccine and unspecified, the subject experienced brachial neuritis. The healthcare professional reported the subject "experienced brachial neuritis. The after receiving TDaP. This occurred at some unspecified time in the past". At the time of reporting the outcome of the brachial neuritis was unspecified.
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Headache, Nausea, Oedema peripheral, Pain
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of nausea in a female subject of unspecified age who was vaccinated with TETANUS vaccine (manufacturer unspecified). a physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of TETANUS vaccine (details unknown). At an unspecified time after vaccination with TETANUS vaccine, the subject experienced nausea, arms redness, swelling arm, pain and headache. At the time of reporting the events were unresolved. No further information was provided.
Age: 24.0
Sex: F
Vaccine: DTP
Symptoms: Blood cholesterol increased, Low density lipoprotein increased, Traumatic brain injury
Clinical narrative: This case was reported by a consumer via other manufacturer and descried the occurrence of traumatic brain injury in a 24-year-old female subject who was vaccinated with DTP vaccine, (manufacturer unspecified). A physician or other health care professional has not verified that report. On an unspecified date the subject received unspecified dose of DTP (unknown). At an unspecified time after vaccination with DTP, the subject experienced traumatic brain injury, increased total cholesterol and increased ldl. On 11 January 2010, manufacturer received a report of alleged adverse drug reactions of traumatic brain injury, increase in total cholesterol and increase in LDL in a 24-year old subject. At the time of reporting the outcome of the traumatic brain injury, increased total cholesterol and increased ldl was unspecified.
Age: 55.0
Sex: M
Vaccine: DTP
Symptoms: Adverse reaction, Asthma, Cough, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 54-year-old male subject who was vaccinated with combined DTP (A or W not known) vaccine. This case also described the occurrence of episode of atrial fibrillation after the subject received ADVAIR 100/50 mcg multi-dose powder inhaler over a period of two days for asthma and cough. A physician or other health care professional has not verified this report. The subject's medical history included atrial fibrillation and hyperthyroidism. Concurrent medical conditions included asthma and cough. There were no concurrent medications. On 22 February 2010 the patient started Fluticasone propionate+salmeterol xinafoate (inhaled) at 2 puff(s) twice per day. Approximately 1 day after starting Fluticasone propionate+salmeterol xinafoate, after his third or fourth dose of ADVAIR, on 23 February 2010, the patient experienced episode of atrial fibrillation. The episode of atrial fibrillation lasted from approximately 1:30 p.m. on 23 February 2010 until 10:00 a.m. on 24 February 2010. On 24 February 2010 the subject received a booster dose of DTP vaccine, unspecified (unknown). On 24 February 2010, the same day that he received DTP vaccine, unspecified and two days after starting Fluticasone propionate-salmeterol xinate, he developed a fever of 101 degrees Fahrenheit. The fever resolved on 25 February 2010. Fluticasone propionate+salmeterol xinafoate was discontinued. This case was assessed as medically serious by GSK. The patient reported an adverse reaction (fever 101 degrees Fahrenheit) to DTP vaccine. He needed a tetanus update and was administered the unknown brand vaccine during a doctor visit. His physician believed that the vaccine was not necessarily the cause of his reported fever. The patient also reported an extended episode of atrial fibrillation after his third or fourth dose of ADVAIR Diskus 100/50 mcg. He was taking ADVAIR for a cough, which immediately resolved following one dose of ADVAIR Diskus. Patient has history of hyperthyroidism, but was not on any medication for this condition at the time of the event. The patient was 19 yrs old at the time of his hyperthyroidism diagnosis. Patient also had a history of atrial fibrillation and had been on blood thinner and beta blocker medications in the past. Patient was not on any medication at the time of the event save for ADAIR 100/50. Patient reported he was under exceptional stress at work and had had a birthday that week. In addition, the patient reported that he has not attended to his nutritional needs of late. These he believed were contributory to the episode of atrial fibrillation as well as the ADVAIR. The extended episode started at 1:30pm and continued until 10:00 am the next day. Patient indicated that his atrial fibrillation episodes usually occur in the middle of the night. Patient stopped using his ADVAIR medication with the onset of the episode, despite his physician's belief that the medication was not the cause of his unusual atrial fibrillation episode.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Cyanosis, Feeling abnormal, Hypotonia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lifeless in a 2-year-old female subject who was vaccinated with INFANRIX, (GlaxoSmithKline), HIBERIX and PREVNAR.  There were no concurrent medications.  On 25 February 2010 the subject received 4th dose of INFANRIX (.5 ml, unknown, right thigh), 2nd dose of HIBERIX (unknown), 4th dose of PREVNAR (unknown).  On 25 February 2010, 12 hours after vaccination with HIBERIX, INFANRIX and PREVNAR, the subject experienced lifeless, blue hand, blue feet and limp body.  The subject's hands and feet turned blue, she became limp and lifeless 12 hours after receiving vaccinations.  The subject was taken to the emergency room but the events resolved before getting there.  The subject returned to the physician's office for follow-up.  At the time of reporting the lifeless, blue hand, blue feet and limp body were resolved.  The healthcare professional considered the events were possibly related to vaccination with INFANRIX, HIBERIX and PREVNAR.
Age: 38.0
Sex: M
Vaccine: DTAP
Symptoms: Drug use for unknown indication, Erythema, Pain, Pyrexia, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of erythema in a 38-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 1 March 2010 at 17:00 the subject received booster dose of INFANRIX (unknown). On 1 March 2010, at the time of vaccination with INFANRIX, the subject experienced drug use for unapproved indication. The 38-year old subject received INFANRIX in error. On 03 March 2010, 2 days after vaccination with INFANRIX, the subject experienced erythema, body pain, and fever. At the time of reporting the erythema was unresolved. On 04 March 2010 body pain fever resolved. The healthcare professional considered the events were probably related to vaccination with INFANRIX.
Age: 0.07
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Adverse reaction, Erythema, Local reaction, Product quality issue, Swelling
Clinical narrative: This case was reported by a physician and described the occurrence of erythema in a 5-year-old subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced erythema, tenderness, swelling and pharmaceutical product complaint. The subject's top part of thighs was red, tender and swollen for approximately three or four days. At the time of the report, no other details were provided. At the time of reporting the erythema, tenderness, and swelling were resolved. This is the first of three subjects the physician reported who experienced adverse events with INFANRIX within two to three weeks; see cases A0851210A and A0851211A. Follow-up information was received on 05 April 2010, via physician. The 5-year-old female subject who was vaccinated with 5th dose of INFANRIX (.5 ml, intramuscular, left thigh) on 12 March 2010; lot number reported as "B091AA". Previous and/or concurrent vaccination included MMR vaccine (non-gsk); Merck; unknown; unknown given on 12 March 2010; poliomyelitis vaccine inactivated IPOL, (non-gsk); non-GSK manufacturer; intramuscular; unknown given on 12 March 2010. The subject received four previous DTaPs. No adverse events were reported with previous vaccinations. On 13 March 2010, 1 day after vaccination with INFANRIX, the subject was diagnosed with a "large local reaction" and experienced erythema, tenderness, swelling and pharmaceutical product complaint. The physician stated the subject was a "healthy child". The physician did not consider the events serious and were not associated with medical history/ concurrent illness, lack of efficacy, erroneous administration, or suspected transmission. On 17 March 2010, the local reaction, erythema, tenderness, and swelling were resolved.
Age: 0.07
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Tenderness
Clinical narrative: This case was reported by a physician and described the occurrence of erythema in a 5-year-old subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced erythema, tenderness, swelling and pharmaceutical product complaint. The subject's top part of thighs was red, tender and swollen for approximately three or four days. At the time of the report, no other details were provided. At the time of reporting the erythema, tenderness, and swelling were resolved. This is the first of three subjects the physician reported who experienced adverse events with INFANRIX within two to three weeks; see cases A0851210A and A0851211A. Follow-up information was received on 05 April 2010, via physician. The 5-year-old female subject who was vaccinated with 5th dose of INFANRIX (.5 ml, intramuscular, left thigh) on 12 March 2010; lot number reported as "B091AA". Previous and/or concurrent vaccination included MMR vaccine (non-gsk); Merck; unknown; unknown given on 12 March 2010; poliomyelitis vaccine inactivated IPOL, (non-gsk); non-GSK manufacturer; intramuscular; unknown given on 12 March 2010. The subject received four previous DTaPs. No adverse events were reported with previous vaccinations. On 13 March 2010, 1 day after vaccination with INFANRIX, the subject was diagnosed with a "large local reaction" and experienced erythema, tenderness, swelling and pharmaceutical product complaint. The physician stated the subject was a "healthy child". The physician did not consider the events serious and were not associated with medical history/ concurrent illness, lack of efficacy, erroneous administration, or suspected transmission. On 17 March 2010, the local reaction, erythema, tenderness, and swelling were resolved.
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Condition aggravated, Eye pain, Headache, Hypersensitivity, Injection site urticaria
Clinical narrative: Pt called, reported: May 4 Pneumococcal vaccine left arm - developed one hive near injection site. Within one hr dev chest, throat and nasal congestion. Did not seek medical attention as he stated it was not life threatening. Sx persisted for a couple of hrs. That pm he developed a migraine with pain behind eyes and base of skull. No n/v, + photosensitivity. Pain eased in morning but worsened throughout the day. No medical attention for headaches. He took VICODIN that he had left over from his surgery. He reported a generalized worsening of his allergy sx. He used his albuterol inhaler but noticed no results. Headaches subsided within one week.
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Migraine, Nasal congestion, Respiratory tract congestion
Clinical narrative: Pt called, reported: May 4 Pneumococcal vaccine left arm - developed one hive near injection site. Within one hr dev chest, throat and nasal congestion. Did not seek medical attention as he stated it was not life threatening. Sx persisted for a couple of hrs. That pm he developed a migraine with pain behind eyes and base of skull. No n/v, + photosensitivity. Pain eased in morning but worsened throughout the day. No medical attention for headaches. He took VICODIN that he had left over from his surgery. He reported a generalized worsening of his allergy sx. He used his albuterol inhaler but noticed no results. Headaches subsided within one week.
Age: 27.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Balance disorder, Chest discomfort, Dizziness, Dysgeusia
Clinical narrative: Vaccinated with 1/2 dose of H1N1 pm of 13 May in left arm. Later that afternoon he noticed congestion of nose, throat and chest. Felt like he was developing pneumonia again with a tickle sensation in his lungs but he could not cough anything up. Later that night he began to notice problems with his balance, +head congestion and falling to right. Ears did not feel stuffy. No dizziness, no fever. Went to bed and slept remainder of night and most of next day. Had worked for 37 hrs prior to vaccination. Balance was feeling better on Friday, 14 May. On Sat 15 May began to notice foul taste in mouth, with nose and chest congestion. Used inhaler, no relief. Developed dizziness (room was not spinning he was, even with eyes closed), he stated he felt weak and was fatigued. Stated "Like I am drunk without the happiness". Went to the ED - dx as having vertigo and prescribed meclizine. Did not fill script as he felt he did not have vertigo. On Sun he slept most of day. Today 17 May reported that his sx are easing, balance has improved, slight stumbling. Vision with slight photosensitivity and slight pressure behind the eyes. States it is like it is hard to keep eyes open.
Age: 27.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Fall, Fatigue, Feeling abnormal, Gait disturbance, Head discomfort
Clinical narrative: Vaccinated with 1/2 dose of H1N1 pm of 13 May in left arm. Later that afternoon he noticed congestion of nose, throat and chest. Felt like he was developing pneumonia again with a tickle sensation in his lungs but he could not cough anything up. Later that night he began to notice problems with his balance, +head congestion and falling to right. Ears did not feel stuffy. No dizziness, no fever. Went to bed and slept remainder of night and most of next day. Had worked for 37 hrs prior to vaccination. Balance was feeling better on Friday, 14 May. On Sat 15 May began to notice foul taste in mouth, with nose and chest congestion. Used inhaler, no relief. Developed dizziness (room was not spinning he was, even with eyes closed), he stated he felt weak and was fatigued. Stated "Like I am drunk without the happiness". Went to the ED - dx as having vertigo and prescribed meclizine. Did not fill script as he felt he did not have vertigo. On Sun he slept most of day. Today 17 May reported that his sx are easing, balance has improved, slight stumbling. Vision with slight photosensitivity and slight pressure behind the eyes. States it is like it is hard to keep eyes open.
Age: 27.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Nasal congestion, Photosensitivity reaction, Respiratory tract congestion, Vertigo
Clinical narrative: Vaccinated with 1/2 dose of H1N1 pm of 13 May in left arm. Later that afternoon he noticed congestion of nose, throat and chest. Felt like he was developing pneumonia again with a tickle sensation in his lungs but he could not cough anything up. Later that night he began to notice problems with his balance, +head congestion and falling to right. Ears did not feel stuffy. No dizziness, no fever. Went to bed and slept remainder of night and most of next day. Had worked for 37 hrs prior to vaccination. Balance was feeling better on Friday, 14 May. On Sat 15 May began to notice foul taste in mouth, with nose and chest congestion. Used inhaler, no relief. Developed dizziness (room was not spinning he was, even with eyes closed), he stated he felt weak and was fatigued. Stated "Like I am drunk without the happiness". Went to the ED - dx as having vertigo and prescribed meclizine. Did not fill script as he felt he did not have vertigo. On Sun he slept most of day. Today 17 May reported that his sx are easing, balance has improved, slight stumbling. Vision with slight photosensitivity and slight pressure behind the eyes. States it is like it is hard to keep eyes open.
Age: 12.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP, VARCEL, FLUN3, HPV4, MNQ
Symptoms: Amnesia, Anxiety, Asthenia, Blood test normal, Cardiac monitoring normal
Clinical narrative: Blurry vision, warts (not genital), twitches, numbness, memory loss, no concentration, confused, trouble breathing, fainting (daily), very allergic to citric acid-now-never before.
Age: 12.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP, VARCEL, FLUN3, HPV4, MNQ
Symptoms: Chest X-ray normal, Computerised tomogram normal, Dizziness, Electrocardiogram normal, Feeling abnormal
Clinical narrative: Blurry vision, warts (not genital), twitches, numbness, memory loss, no concentration, confused, trouble breathing, fainting (daily), very allergic to citric acid-now-never before.
Age: 12.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP, VARCEL, FLUN3, HPV4, MNQ
Symptoms: Headache, Hypersomnia, Influenza like illness, Injection site swelling, Malaise
Clinical narrative: Blurry vision, warts (not genital), twitches, numbness, memory loss, no concentration, confused, trouble breathing, fainting (daily), very allergic to citric acid-now-never before.
Age: 12.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP, VARCEL, FLUN3, HPV4, MNQ
Symptoms: Muscle twitching, Pain in extremity, Paraesthesia, Syncope, Urine analysis normal
Clinical narrative: Blurry vision, warts (not genital), twitches, numbness, memory loss, no concentration, confused, trouble breathing, fainting (daily), very allergic to citric acid-now-never before.
Age: 12.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP, VARCEL, FLUN3, HPV4, MNQ
Symptoms: Amnesia, Confusional state, Disturbance in attention, Dyspnoea, Hypersensitivity
Clinical narrative: Blurry vision, warts (not genital), twitches, numbness, memory loss, no concentration, confused, trouble breathing, fainting (daily), very allergic to citric acid-now-never before.
Age: 12.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP, VARCEL, FLUN3, HPV4, MNQ
Symptoms: Hypoaesthesia, Muscle twitching, Skin papilloma, Syncope, Vision blurred
Clinical narrative: Blurry vision, warts (not genital), twitches, numbness, memory loss, no concentration, confused, trouble breathing, fainting (daily), very allergic to citric acid-now-never before.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: SEVERE SWELLING AT INJECTION SITE, VERY PAINFUL, VERY RED AND HOT TO THE TOUCH. HEADACHE AND TIREDNESS. LASTED 3 DAYS.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: SEVERE SWELLING AT INJECTION SITE, VERY PAINFUL, VERY RED AND HOT TO THE TOUCH. HEADACHE AND TIREDNESS. LASTED 3 DAYS.
Age: 61.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site pain, Pain, Pain in extremity, X-ray abnormal
Clinical narrative: Patient received H1N1 shot on 1-7-10 and c/o pain at time of injection, right arm pain. There was some tenderness at injection site, a little bump and maybe a sl rash about a week after she started having shooting stabbing like pains in the arm. The pain gradually got worse. Went to doctor and was taking ibuprofen for the pain and started PT. It seems to be worse with PT. Went to doctor a few days ago & he started her on some pain pills. It's better if she moves slowly & ices the area. X-ray was done.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at site of injection treated as cellulitis with CLINDAMYCIN.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Rash, Rash erythematous, Rash papular, Skin lesion
Clinical narrative: Patient developed rash/seen in office/not itchy his T about 101 degrees. Rash c/w varicella (Fluid-filled small papular lesions with erythematous base), confirmed with my partner also.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal discomfort, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Soreness of arm, red and swelling at injection site, upset stomach.
Age: 3.0
Sex: M
Vaccine: HIBV, PNC13, HIBV, PNC13
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Seen for well visit Friday and got HIB and PREVNAR, Friday night developed rash over body-has gotten progressively worse since Friday, seems itchy per day, no fever, no runny nose, no cough, no other symptoms, no new foods, not on any abx.
Age: 3.0
Sex: M
Vaccine: HIBV, PNC13, HIBV, PNC13
Symptoms: Erythema multiforme
Clinical narrative: Seen for well visit Friday and got HIB and PREVNAR, Friday night developed rash over body-has gotten progressively worse since Friday, seems itchy per day, no fever, no runny nose, no cough, no other symptoms, no new foods, not on any abx.