chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAPIPV
Symptoms: Erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of erythema in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (.5 ml, route unknown). At an unspecified time after vaccination with KINRIX, the subject experienced erythema, hardness injection site, swelling injection site and injection site warmth. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with KINRIX. This case corresponds to a pharmaceutical product complaint. The healthcare professional reported that 15 subjects experienced the same events in the same time period after vaccination with KINRIX. At the time of reporting, no additional information was available. This is case 15 of 15 (see case IDs A0860669A, A0860688A, A0860690A - A0860701A for the other reports).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of red bump at injection site in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). The subject's medical history included bone marrow biopsy, "calicimia minor", lymph node biopsy, pneumonia and respiratory syncytial virus. Concurrent vaccination included MMR II vaccine (non-GSK); Merck given on 19 May 2010; VARIVAX (non-GSK); Merck given on 19 May 2010. On 19 May 2010 at 11:00 the subject received 1st dose of KINRIX (.5 ml, unknown route, left thigh). On 20 May 2010, 1 day after vaccination with KINRIX, the subject experienced red bump at injection site and hotness at injection site. The event was descried as "red, hot knot 3 centimeters at site". At the time of reporting the events were unresolved.
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Contusion, Electromyogram, Mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Hepatitis vaccine in left deltoid caused huge bruise after 13 days; extreme pain in left arm has continued to this day - limited movement in left arm, extreme pain.
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Hepatitis vaccine in left deltoid caused huge bruise after 13 days; extreme pain in left arm has continued to this day - limited movement in left arm, extreme pain.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: After receiving the DTap shot, patient developed a red patch about the size of a softball on his arm in a ring around the injection site.  It was red and warm to the touch.  No fever or itching or significant pain was reported by 5yr old.  Still red but seems to be fading as of 5/29/10, 3 days after shot. Seen by Dr. on 5/28/10 who said it was a "localized reaction" and not to worry unless it got worse.
Age: 0.75
Sex: F
Vaccine: DTAP
Symptoms: Cough, Hypersensitivity, Rhinorrhoea
Clinical narrative: She began producing lots of mucus nasally.  This caused a cough.  No fever.  No lymphadenopathy.  It comes across as an allergic reaction to her second shot.
Age: 47.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blood test, Chest X-ray, Decreased appetite, Dizziness, Echocardiogram
Clinical narrative: Flu-like symptoms for 2 days, then again one week later including increased heart rate, sweating, shakes, lightheadedness, decreased appetite, significant weight loss (15 lbs).
Age: 47.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Electrocardiogram, Heart rate increased, Hyperhidrosis, Hyperthyroidism, Influenza like illness
Clinical narrative: Flu-like symptoms for 2 days, then again one week later including increased heart rate, sweating, shakes, lightheadedness, decreased appetite, significant weight loss (15 lbs).
Age: 47.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Iodine uptake, Tremor, Ultrasound thyroid, Weight decreased
Clinical narrative: Flu-like symptoms for 2 days, then again one week later including increased heart rate, sweating, shakes, lightheadedness, decreased appetite, significant weight loss (15 lbs).
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain in extremity, X-ray normal
Clinical narrative: Pain in upper arm never left.  Pain continues to present (May 29, 2010) and includes radiating pain in right shoulder, right elbow, and pain extends down to tendons in right hand. Pain has resulted in a referral to an orthopedic which now includes 3 visits, and two cortisone shots, that last of which only caused more pain.  Told to get an MRI, possible partial tear in rotator cuff, physical therapy suggested.  xrays for bones are fine.  Onset of pain began at time of the seasonal flu shot...wondering if there is a correlation.  Much pain and inconvenience and cost involved.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Started to get red at site, redness got larger, hard center, raised. Pt discharged on 5/15 with redness around 10 cm in diameter.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Asthenia, Back pain, Condition aggravated, Depression
Clinical narrative: Before I received the shot, I was a normal, healthy and very active teenager and an excellent student. After the shot, everything changed. My former gynecologist gave me the shot and when I came back 3 days later to tell her what had happened (I'll explain after this), she denied giving me the shot and basically said that there was nothing she could do to help me. I had a severe allergic reaction a few hours after the first shot. I had severe nausea, severe dizziness, and severe shortness of breath. I also was extremely pale and thought that and felt like I was going to pass out. I was taken to the emergency room by my mother and they determined that it was a severe allergic reaction to the shot and suggested to me not to get the second or third shot, which I never did. The following day, I woke up with severe pain and stiffness throughout my whole body, where it was most severe in my entire neck and my entire back. I had never ever had pain this severe in my life until the day after I got the shot and I believe that they are related. I have had the severe pain ever since. It has completely and negatively affected my entire life. I was no longer able to be active, I gained weight, and my grades dropped dramatically. It has also affected my depression at some points and makes it worse sometimes, when before the medication that I am on, worked all of the time, until I had this severe neck and back pain, which at times, has made my depression worse. I am still having a lot of trouble with all of this horrific pain. It has completely debilitated me and I am at a loss for what to do next, because I have tried almost everything in the book, minus surgery.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Educational problem, Hypersensitivity, Musculoskeletal stiffness
Clinical narrative: Before I received the shot, I was a normal, healthy and very active teenager and an excellent student. After the shot, everything changed. My former gynecologist gave me the shot and when I came back 3 days later to tell her what had happened (I'll explain after this), she denied giving me the shot and basically said that there was nothing she could do to help me. I had a severe allergic reaction a few hours after the first shot. I had severe nausea, severe dizziness, and severe shortness of breath. I also was extremely pale and thought that and felt like I was going to pass out. I was taken to the emergency room by my mother and they determined that it was a severe allergic reaction to the shot and suggested to me not to get the second or third shot, which I never did. The following day, I woke up with severe pain and stiffness throughout my whole body, where it was most severe in my entire neck and my entire back. I had never ever had pain this severe in my life until the day after I got the shot and I believe that they are related. I have had the severe pain ever since. It has completely and negatively affected my entire life. I was no longer able to be active, I gained weight, and my grades dropped dramatically. It has also affected my depression at some points and makes it worse sometimes, when before the medication that I am on, worked all of the time, until I had this severe neck and back pain, which at times, has made my depression worse. I am still having a lot of trouble with all of this horrific pain. It has completely debilitated me and I am at a loss for what to do next, because I have tried almost everything in the book, minus surgery.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Neck pain, Pallor, Weight increased
Clinical narrative: Before I received the shot, I was a normal, healthy and very active teenager and an excellent student. After the shot, everything changed. My former gynecologist gave me the shot and when I came back 3 days later to tell her what had happened (I'll explain after this), she denied giving me the shot and basically said that there was nothing she could do to help me. I had a severe allergic reaction a few hours after the first shot. I had severe nausea, severe dizziness, and severe shortness of breath. I also was extremely pale and thought that and felt like I was going to pass out. I was taken to the emergency room by my mother and they determined that it was a severe allergic reaction to the shot and suggested to me not to get the second or third shot, which I never did. The following day, I woke up with severe pain and stiffness throughout my whole body, where it was most severe in my entire neck and my entire back. I had never ever had pain this severe in my life until the day after I got the shot and I believe that they are related. I have had the severe pain ever since. It has completely and negatively affected my entire life. I was no longer able to be active, I gained weight, and my grades dropped dramatically. It has also affected my depression at some points and makes it worse sometimes, when before the medication that I am on, worked all of the time, until I had this severe neck and back pain, which at times, has made my depression worse. I am still having a lot of trouble with all of this horrific pain. It has completely debilitated me and I am at a loss for what to do next, because I have tried almost everything in the book, minus surgery.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Chest X-ray, Febrile convulsion, Full blood count, Influenza serology, Pyrexia
Clinical narrative: Fevers up to 103.3 and febrile seizures.
Age: 2.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Anger, Dyskinesia, Frustration, Pyrexia, Screaming
Clinical narrative: She was given chickenpox vaccination and MMR.  Started with fever and she became jerky. She is now screaming about everything all day long, will not sit still for more then five minutes.  She no longer plays without screaming.  She reacts to small things all day long.  She is not the same child she has outburst of anger for no reason.  She asks for things when she already has them in her hand.  She seems to not be able to get comfortable at any time, seems frustrated and can't explain what is wrong.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Asthma, Bronchial hyperreactivity, Chest discomfort, Chronic obstructive pulmonary disease
Clinical narrative: Hives over my whole body, wheezing and chest contraction and tightness, very fast heart rate, dizziness, nausea and extreme weakness. Loss of appetite and mental confusion.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Confusional state, Decreased appetite, Dizziness, Heart rate increased, Muscle contractions involuntary
Clinical narrative: Hives over my whole body, wheezing and chest contraction and tightness, very fast heart rate, dizziness, nausea and extreme weakness. Loss of appetite and mental confusion.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Urticaria, Viral infection, Wheezing
Clinical narrative: Hives over my whole body, wheezing and chest contraction and tightness, very fast heart rate, dizziness, nausea and extreme weakness. Loss of appetite and mental confusion.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain, Skin warm
Clinical narrative: Increasing redness, swelling, warmth which extends from the elbow to the shoulder.  No fever.  Mild pain. Diagnosed with cellulitis and started on Clindamycin.  Asked to follow up with the primary doctor in 2 days.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, FLUX, HBHEPB, MMR
Symptoms: Abdominal pain upper, Abnormal behaviour, Crying, Head banging, Non-cardiac chest pain
Clinical narrative: Patient was filled with severe pain when ready to eat and cried in pain in the upper stomach, chest area. Severe pain in upper stomach, severe crying just prior to eating; pain associated with eating continued and behavioral changes including head-banging, crying for little apparent reason.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, FLUX, HBHEPB, MMR
Symptoms: Oesophagogastric fundoplasty, Vomiting
Clinical narrative: Patient was filled with severe pain when ready to eat and cried in pain in the upper stomach, chest area. Severe pain in upper stomach, severe crying just prior to eating; pain associated with eating continued and behavioral changes including head-banging, crying for little apparent reason.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Facial palsy, Guillain-Barre syndrome
Clinical narrative: Paralysis of left side of face, then right side the next day. Admitted to hospital 4/23/2010 and treated for Guillain Barre Syndrome.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Asthenia, Chills, Lethargy, Malaise, Nausea
Clinical narrative: Lethargy, nausea, general feeling of illness which progressed to severe body aches, chills, fever over 100, weakness.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Pain, Pyrexia
Clinical narrative: Lethargy, nausea, general feeling of illness which progressed to severe body aches, chills, fever over 100, weakness.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Autism spectrum disorder, Facial palsy, Regressive behaviour, Swelling face
Clinical narrative: Significant facial swelling one side, eye drooping.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Rash vesicular, Skin lesion
Clinical narrative: Varicella-like rash appearing on torso, groin, and upper thigh with 50+ lesions.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Hypophagia, Irritability, Urticaria
Clinical narrative: Extreme fussiness. Refusal of bottle/liquids. HIVES.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site swelling, Pulmonary function test normal
Clinical narrative: This 12 month old female patient received her 0.05 ml of both the MMR and Varicella vaccine on 06May2010 at the Health Center. The patient's mom and dad stated that the child was not sick and answered no to all questions regarding risks. At 0930 on 06May2010 after receiving both vaccines the child had a localized reaction which consisted of a 2-3cm firm blanchable swell to her outer thighs bilaterally. The child was not respiratory compromised and had no acute distress. The resolution status is unknown.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Musculoskeletal pain, Pruritus
Clinical narrative: Broke out with blisters and pain on left buttock. Intense itching for several weeks. Took Acyclovir 800 mg 1 tab 5 times daily.
Age: 17.0
Sex: F
Vaccine: TYP
Symptoms: Blood glucose normal, Blood potassium decreased, Full blood count normal, Laboratory test normal, Respiratory distress
Clinical narrative: Wheezing, Respiratory Distress; treated with respiratory treatments and symptoms resolved.
Age: 17.0
Sex: F
Vaccine: TYP
Symptoms: Wheezing
Clinical narrative: Wheezing, Respiratory Distress; treated with respiratory treatments and symptoms resolved.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: First noticed redness and soreness at injection site 1 day after vaccination.  Later that day I became feverish (101F) The site was very swollen and painful.  Area of redness 3.5 inches in diameter.  I called the on-call doctor who recommended Benadryl and additional Tylenol (I was already taking Norco for pain post appendectomy). The fever subsided by the next day, and the redness and swelling subsided a few days after that.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: Pt had hives by injection site following administration.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Barium enema, Blood test, Intussusception, Ultrasound abdomen, Vomiting
Clinical narrative: Information has been received from a physician's assistant concerning a patient who on an unspecified dates was vaccinated orally with the first, second and third doses of ROTATEQ (Lot #s not provided). It was reported that, on approximately 10-MAY-2010 the patient had to be hospitalized (length not specified) with intussusception. At the time of the report the patient's outcome for intussusception was not reported. Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: X-ray
Clinical narrative: Information has been received from a physician's assistant concerning a patient who on an unspecified dates was vaccinated orally with the first, second and third doses of ROTATEQ (Lot #s not provided). It was reported that, on approximately 10-MAY-2010 the patient had to be hospitalized (length not specified) with intussusception. At the time of the report the patient's outcome for intussusception was not reported. Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician's assistant concerning a patient who on an unspecified dates was vaccinated orally with the first, second and third doses of ROTATEQ (Lot #s not provided). It was reported that, on approximately 10-MAY-2010 the patient had to be hospitalized (length not specified) with intussusception. At the time of the report the patient's outcome for intussusception was not reported. Additional information has been requested.
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Blood test, Electromyogram, Fatigue, Feeling cold, Immediate post-injection reaction
Clinical narrative: Initial report was received on 18 May 2010 from a health care professional, who is also the patient. A female patient (age and date of birth not reported) had received a first dose intramuscular left arm injection of INFLUENZA A (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP068AA on 19 December 2010 and immediately following vaccination, she complained of pain and burning at the injection site and down to her right foot. On 23 December 2009, she developed tingling and burning in her left leg up to her knee. Tingling and burning were also present in her other foot and hands. She went to the emergency room and received Solumedrol as corrective treatment on 24 December 2009 (year reported as 2010) and was released. According to the reporter, up until the time of the report, she has experienced "transient migratory" itchy skin and a prickly feeling everywhere. The reporter declined to provide any additional information and stated that they wanted to file their own VAERS report. The reporter further stated that they them self did not want to be contacted for follow-up, nor did they want their physician or health department to be contacted for follow-up. Outcome was reported as not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Muscle spasms, Muscle twitching, Myalgia, Neuralgia, Pain
Clinical narrative: Initial report was received on 18 May 2010 from a health care professional, who is also the patient. A female patient (age and date of birth not reported) had received a first dose intramuscular left arm injection of INFLUENZA A (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP068AA on 19 December 2010 and immediately following vaccination, she complained of pain and burning at the injection site and down to her right foot. On 23 December 2009, she developed tingling and burning in her left leg up to her knee. Tingling and burning were also present in her other foot and hands. She went to the emergency room and received Solumedrol as corrective treatment on 24 December 2009 (year reported as 2010) and was released. According to the reporter, up until the time of the report, she has experienced "transient migratory" itchy skin and a prickly feeling everywhere. The reporter declined to provide any additional information and stated that they wanted to file their own VAERS report. The reporter further stated that they them self did not want to be contacted for follow-up, nor did they want their physician or health department to be contacted for follow-up. Outcome was reported as not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Pain of skin, Paraesthesia, Pruritus, Sleep disorder
Clinical narrative: Initial report was received on 18 May 2010 from a health care professional, who is also the patient. A female patient (age and date of birth not reported) had received a first dose intramuscular left arm injection of INFLUENZA A (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP068AA on 19 December 2010 and immediately following vaccination, she complained of pain and burning at the injection site and down to her right foot. On 23 December 2009, she developed tingling and burning in her left leg up to her knee. Tingling and burning were also present in her other foot and hands. She went to the emergency room and received Solumedrol as corrective treatment on 24 December 2009 (year reported as 2010) and was released. According to the reporter, up until the time of the report, she has experienced "transient migratory" itchy skin and a prickly feeling everywhere. The reporter declined to provide any additional information and stated that they wanted to file their own VAERS report. The reporter further stated that they them self did not want to be contacted for follow-up, nor did they want their physician or health department to be contacted for follow-up. Outcome was reported as not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Initial report was received on 18 May 2010 from a health care professional, who is also the patient. A female patient (age and date of birth not reported) had received a first dose intramuscular left arm injection of INFLUENZA A (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP068AA on 19 December 2010 and immediately following vaccination, she complained of pain and burning at the injection site and down to her right foot. On 23 December 2009, she developed tingling and burning in her left leg up to her knee. Tingling and burning were also present in her other foot and hands. She went to the emergency room and received Solumedrol as corrective treatment on 24 December 2009 (year reported as 2010) and was released. According to the reporter, up until the time of the report, she has experienced "transient migratory" itchy skin and a prickly feeling everywhere. The reporter declined to provide any additional information and stated that they wanted to file their own VAERS report. The reporter further stated that they them self did not want to be contacted for follow-up, nor did they want their physician or health department to be contacted for follow-up. Outcome was reported as not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Pruritus
Clinical narrative: Initial report was received on 18 May 2010 from a health care professional, who is also the patient. A female patient (age and date of birth not reported) had received a first dose intramuscular left arm injection of INFLUENZA A (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP068AA on 19 December 2010 and immediately following vaccination, she complained of pain and burning at the injection site and down to her right foot. On 23 December 2009, she developed tingling and burning in her left leg up to her knee. Tingling and burning were also present in her other foot and hands. She went to the emergency room and received Solumedrol as corrective treatment on 24 December 2009 (year reported as 2010) and was released. According to the reporter, up until the time of the report, she has experienced "transient migratory" itchy skin and a prickly feeling everywhere. The reporter declined to provide any additional information and stated that they wanted to file their own VAERS report. The reporter further stated that they them self did not want to be contacted for follow-up, nor did they want their physician or health department to be contacted for follow-up. Outcome was reported as not recovered. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Vaccines administered 5-25-10 at 12noon approximately 5-26-10 circled area approximately 3cm in diameter noted hard, red with small amt of swelling, 5-27-10 12noon increased swelling hot and itching: cold compress applied. At 800pm took to ER for evaluation.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV1
Symptoms: Decreased eye contact, Somnolence
Clinical narrative: Very sleepy, not making eye contact x 2 days then back to normal. Patient awake only to eat then back to sleep x 48 hrs then normal.
Age: 2.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Rash
Clinical narrative: Patient broke out into rash. Parents did not notify agency until May 28, 2010.
Age: 1.53
Sex: F
Vaccine: DTAP
Symptoms: Decreased appetite, Irritability, Pyrexia
Clinical narrative: Fever that reached 106, fussiness, loss of appetite.  Treatment: Tylenol and Motrin, other fever reducing techniques.
Age: 1.14
Sex: M
Vaccine: DTAPH, IPV
Symptoms: Emotional distress, Injection site swelling, Irritability, Movement disorder
Clinical narrative: Irritability, unconsoled, unable or unwilling to move freely body or neck for 24 hours, swelling at the injection site.
Age: 47.0
Sex: M
Vaccine: HEPAB
Symptoms: Lip swelling, Rash, Rash pruritic
Clinical narrative: Pt reports the day after inj #2 of Twinrix that he noted an itching rash on chest and upper back. Also reported his lips felt swollen. Denied SOB or difficulty swallowing.
Age: 36.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Chills, Hypoaesthesia, Nausea, Oropharyngeal pain
Clinical narrative: Telephone call 6/1/10 from client stating had MMR 5/27/10 and began with R ankle, R calf, R knee pain (3-4 pain level) on 5/28/10 pm progressing 5/29, 5/30, 5/31 including L elbow, L ankle, L knee, R hand numbness - Pain increased to 10 out of 10 5/31/10 difficult to ambulate - Pain increased at rest - No swelling noted but pain localized to joint areas - c/o sore throat x 24h 5/28-5/29. Some rash, fever, n/v, positive chills, 5/29, 5/30 and 5/31.
Age: 36.0
Sex: M
Vaccine: MMR
Symptoms: Pain in extremity, Pyrexia, Rash, Vomiting
Clinical narrative: Telephone call 6/1/10 from client stating had MMR 5/27/10 and began with R ankle, R calf, R knee pain (3-4 pain level) on 5/28/10 pm progressing 5/29, 5/30, 5/31 including L elbow, L ankle, L knee, R hand numbness - Pain increased to 10 out of 10 5/31/10 difficult to ambulate - Pain increased at rest - No swelling noted but pain localized to joint areas - c/o sore throat x 24h 5/28-5/29. Some rash, fever, n/v, positive chills, 5/29, 5/30 and 5/31.
Age: 36.0
Sex: F
Vaccine: HEP, VARCEL, HEP, VARCEL
Symptoms: Pruritus generalised, Rash
Clinical narrative: Pt states has a "rash" feels bumpy & itchy on arms & legs & abdomen. Raised area on rt abdomen about 10-15 & rt. leg. Began Tues. NOC with itching. "Bumps" began Wed. Recommended BENADRYL.
Age: 36.0
Sex: F
Vaccine: HEP, VARCEL, HEP, VARCEL
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: Pt states has a "rash" feels bumpy & itchy on arms & legs & abdomen. Raised area on rt abdomen about 10-15 & rt. leg. Began Tues. NOC with itching. "Bumps" began Wed. Recommended BENADRYL.
Age: 23.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Pruritus, Throat irritation, Tinnitus
Clinical narrative: Pt c/o itching, tingling to throat, "buzzing to ears" within 15 min of receiving vaccines.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site cellulitis
Clinical narrative: L arm cellulitis.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: 12 cm X 8 cm erythema, no fever, warm to touch, slight pain when this area is bumped. Instructed pt. to take BENADRYL 25 mg and CLARITIN 10 mg for next 3-7, apply ice to area BID.
Age: 51.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Headache - Fever - 100 - TYLENOL. Pain, swelling at injection site.
Age: 24.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Nausea, Pain, Pyrexia, Vertigo
Clinical narrative: Fever, body aches, nausea, vertigo.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling and pain.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired drug administered, Eye swelling, Ocular hyperaemia
Clinical narrative: Information has been received from a healthcare worker concerning a 10 year old male patient with no pertinent medical history, drug reactions or allergies who on 20-MAY-2010 at 9:00 A.M. was vaccinated SQ with a dose of VARIVAX (Merck) (dose and lot number not reported). There was not concomitant medication reported. At 3:00 P.M. on the same day, while the patient was on a field trip, he developed swelling around the eyes and redness. He reported back to the office where he received EPIPEN and then he was sent to the emergency room. Subsequently, on the same day (unspecified hour), the patient recovered from swelling around the eyes and redness. It was later discovered that the patient received an expired product (13-MAR-2010). No laboratories tests were performed. Swelling around the eyes and redness around the eyes were considered to be an other important medical events. Additional information has been requested.
Age: 0.79
Sex: M
Vaccine: HEP
Symptoms: Acute disseminated encephalomyelitis, Bulbar palsy, CSF cell count normal, CSF glucose normal, CSF lactate normal
Clinical narrative: Lethargy, bulbar symptoms, paralysis. Final diagnosis ADEM.
Age: 0.79
Sex: M
Vaccine: HEP
Symptoms: CSF protein normal, Cytomegalovirus test positive, Lethargy, Metabolic function test, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Lethargy, bulbar symptoms, paralysis. Final diagnosis ADEM.
Age: 0.79
Sex: M
Vaccine: HEP
Symptoms: Paralysis
Clinical narrative: Lethargy, bulbar symptoms, paralysis. Final diagnosis ADEM.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Abdominal discomfort, Chills, Dizziness, Erythema, Fatigue
Clinical narrative: Extremely sore arm, very hot, red and swollen, fatigue, dizziness, chills.  These symptoms continued to get worse throughout the day and I spent next couple of days sleeping with high fever ranging from 100.8 to 102.1, body aches, extreme dizziness, sick stomach, headache.  To date, 6 days later, many symptoms have gone away, but my arm is  still very red, swollen and hot.  Fever has dissipated, but fatigue and soreness continue.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Headache, Hypersomnia, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Extremely sore arm, very hot, red and swollen, fatigue, dizziness, chills.  These symptoms continued to get worse throughout the day and I spent next couple of days sleeping with high fever ranging from 100.8 to 102.1, body aches, extreme dizziness, sick stomach, headache.  To date, 6 days later, many symptoms have gone away, but my arm is  still very red, swollen and hot.  Fever has dissipated, but fatigue and soreness continue.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia, Skin warm
Clinical narrative: Extremely sore arm, very hot, red and swollen, fatigue, dizziness, chills.  These symptoms continued to get worse throughout the day and I spent next couple of days sleeping with high fever ranging from 100.8 to 102.1, body aches, extreme dizziness, sick stomach, headache.  To date, 6 days later, many symptoms have gone away, but my arm is  still very red, swollen and hot.  Fever has dissipated, but fatigue and soreness continue.
Age: 0.19
Sex: F
Vaccine: RV5
Symptoms: Constipation, Crying, Fatigue, Haematochezia, Irritability
Clinical narrative: Initial information has been received from a female consumer concerning her 9 week old daughter with no pertinent medical history and no allergies who on 03-MAY-2010 was vaccinated orally with the first dose of ROTATEQ (lot# 665162/1633Y). There was no concomitant medication. On 03-MAY-2010 the patient was reported to be very fatigued and cranky the day and night after the vaccination. The patient vomited which seemed severe for a couple of days. She was also constipated which progressed and got worse. She was screaming and crying trying to pass stools. On 13-MAY-2010 and 14-MAY-2010 it seemed that the constipation cleared up. Last night (17-MAY-2010), the patient had a mild form of constipation. Today, on 18-MAY-2010, the patient had red streaks in normal stools. It was reported that the patient was seen at the office on 06-MAY-2010 for the constipation and received DTAP.  The mother was unsure if her daughter receiving the DTAP made the constipation worse. There were no laboratory diagnostics studies performed. At the time of this report, the patient had not recovered. Additional information was received from a medical assistant who stated that the patient only received ROTATEQ on 03-MAY-2010 (because the mother didn't believe in vaccines"). She confirmed that the patient was not seen on 06-MAY-2010 for the constipation and DTAP administration, as reported by the mother. It was not until the mother called the office on 18-MAY-2010 that the staff learned of some of these events. Upon internal review, red streak in normal stool was determined to be other important medical event. Additional information is not expected.
Age: 0.19
Sex: F
Vaccine: RV5
Symptoms: Screaming, Vomiting
Clinical narrative: Initial information has been received from a female consumer concerning her 9 week old daughter with no pertinent medical history and no allergies who on 03-MAY-2010 was vaccinated orally with the first dose of ROTATEQ (lot# 665162/1633Y). There was no concomitant medication. On 03-MAY-2010 the patient was reported to be very fatigued and cranky the day and night after the vaccination. The patient vomited which seemed severe for a couple of days. She was also constipated which progressed and got worse. She was screaming and crying trying to pass stools. On 13-MAY-2010 and 14-MAY-2010 it seemed that the constipation cleared up. Last night (17-MAY-2010), the patient had a mild form of constipation. Today, on 18-MAY-2010, the patient had red streaks in normal stools. It was reported that the patient was seen at the office on 06-MAY-2010 for the constipation and received DTAP.  The mother was unsure if her daughter receiving the DTAP made the constipation worse. There were no laboratory diagnostics studies performed. At the time of this report, the patient had not recovered. Additional information was received from a medical assistant who stated that the patient only received ROTATEQ on 03-MAY-2010 (because the mother didn't believe in vaccines"). She confirmed that the patient was not seen on 06-MAY-2010 for the constipation and DTAP administration, as reported by the mother. It was not until the mother called the office on 18-MAY-2010 that the staff learned of some of these events. Upon internal review, red streak in normal stool was determined to be other important medical event. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Red indurated area around shot area. 5.5X3.5 cm. No drainage. Not painful.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Alopecia, Arthralgia, Computerised tomogram, Fatigue
Clinical narrative: 4 months after 3rd shot got 24 hour headaches. Other symptoms then started- fatigue, hair loss, numbness in hands and feet, joint pain, fainting, rapid heart rate, POTS, now at 9 months after shot started stomach issues. It hurts after eating anything.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Heart rate abnormal, Hypoaesthesia, Nuclear magnetic resonance imaging, Syncope
Clinical narrative: 4 months after 3rd shot got 24 hour headaches. Other symptoms then started- fatigue, hair loss, numbness in hands and feet, joint pain, fainting, rapid heart rate, POTS, now at 9 months after shot started stomach issues. It hurts after eating anything.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: 4 months after 3rd shot got 24 hour headaches. Other symptoms then started- fatigue, hair loss, numbness in hands and feet, joint pain, fainting, rapid heart rate, POTS, now at 9 months after shot started stomach issues. It hurts after eating anything.
Age: 24.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: I woke up around 0330 with a searing pain in my right shoulder area. I couldn't move or touch it and it even hurt too much to roll my sleeve up to look at it. I finally was able to roll up my sleeve and my whole shoulder was completely swollen. I took a couple of ibuprofen and iced it for about 2 hours. When I woke up it was still painful to lift my arm but the pain had subsided considerably.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood blister, Contusion, Eyelid oedema, Fall, Head injury
Clinical narrative: Vaccinations administered at approximately 2:20 pm. Pt. was instructed to remain seated. I was speaking to pt.'s mother for approximately 10 min. when episode occurred. Pt. did not state feeling ill or faint. Suddenly, she rolled forward out of chair onto floor. Head struck floor (slightly puffy over L eyes et slight bruise L cheek) 1-2mm blood blister on R index finger after fall.
Age: 46.0
Sex: F
Vaccine: TTOX
Symptoms: Blood potassium decreased, Laboratory test, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Vaccine given 3-8-10. No temp. Complained first time pain 3-16-10. X Ray, lab work, MRI - Ortho consult. (Detailed medical records upon request). "Pt arm felt like concrete" right after injection.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Left thigh red area and swollen and hard golf ball size.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Varicella post vaccine
Clinical narrative: Pt seen 5/27/10 chief complaint red bump on left leg upon exam found shot site red and 2 chicken pox on body.
Age: 1.39
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling, Wound
Clinical narrative: Left upper thigh with about 5-7 cm area of swelling and erythema with visible puncture mark.
Age: 21.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Rash
Clinical narrative: Pt called about 45 min- 1hr after receiving vaccines - c/o rash on neck. Next day reported to us that this had resolved after 2 doses BENADRYL.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around vaccine site, ice pack given.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Gait disturbance, Injection site pain, Pain in extremity
Clinical narrative: Child with c/o severe pain to upper (L) thigh, limping & not wanting to walk, no redness.
Age: 38.0
Sex: M
Vaccine: VARCEL
Symptoms: Fatigue, Injection site vesicles, Rash maculo-papular, Skin lesion, Varicella virus test negative
Clinical narrative: Fatigue on 5/16/10. Vesicle on left deltoid. Maculo-papular lesions on his arms and legs and two in his scalp.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Electrocardiogram normal, Fall, Immediate post-injection reaction, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Patient collapsed immediately following the Gardasil shot.  She fell to her right side. Her mouth dropped open and her eyes were open. She was nonresponsive. She came to after a minute or two and said everything went black - sort of like she fainted but her eyes were not closed.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: Rec'd telephone call fpm patient mother about 1/2 hour after they left.  Mother staes patient has whelps on her body and her tongue.  Advise mother if she had Benadryl to give now and take her to the E.R.
Age: 5.0
Sex: F
Vaccine: DTP, VARCEL
Symptoms: Crying, Nightmare, Screaming, Sleep terror
Clinical narrative: Daughter began to experience night terrors.  She sits up in bed screaming and crying and can not be awakened.  She also has been experiencing severe nightmares.  This went from occurring every few months to occurring nightly since the night after her 5 year old vaccinations.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chills, Hyperhidrosis, Oropharyngeal pain, Pain
Clinical narrative: Fever 102, chills, body aches, sore throat, sweating, weakness. Went to rapid care on 5/30/2010. Was given antibiotic prescription and injection.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Fever 102, chills, body aches, sore throat, sweating, weakness. Went to rapid care on 5/30/2010. Was given antibiotic prescription and injection.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Abasia, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Seemed to have pain in (L) leg 5/27/10 would not walk, erythema. 5/28/10 no pain, no erythema + edema. Pulses good. Able to walk today. Tx: continue to observe; Rx for BENADRYL given. 5/27/10 symptoms reported by parent.
Sex: U
Vaccine: RAB
Symptoms: Diverticulitis, Inappropriate schedule of drug administration
Clinical narrative: Initial spontaneous report received from a pharmacist via professional information (562AE10) on 17 May 2010: This patient initiated RABIPUR injection for a dog bite on an unspecified date about 2 weeks ago (from the time of this report). On an unspecified date the patient was hospitalized with diverticulitis. The reporter was not sure whether this was a pre-existing condition. The patient also had not received his day 7 dose, however clarified that the patient had not had further doses of post exposure treatment (not received correct dosing schedule). No further information was provided at the time of this report.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Dyskinesia, Gaze palsy
Clinical narrative: Mom called on 5/27/2010 stating that child was noted to having jerking movements that was accompanied by staring. These episodes occurred about 7 times approx 10 seconds apart then stopped then again at 11:00 PM X 4.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Gait disturbance, Injection site swelling, Oedema peripheral, Pain
Clinical narrative: S: Pt's mom states he woke up this AM with swelling of L thigh and he was unable to walk on it. During the day pain improved, but the swelling has worsened. O: L thigh erythematous lesion L mid thigh edema of upper thigh extending toward knee ROM and patella reflex intact. No warmth noted at thigh.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Skin lesion
Clinical narrative: S: Pt's mom states he woke up this AM with swelling of L thigh and he was unable to walk on it. During the day pain improved, but the swelling has worsened. O: L thigh erythematous lesion L mid thigh edema of upper thigh extending toward knee ROM and patella reflex intact. No warmth noted at thigh.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Eye swelling, Oedema peripheral, Tenderness
Clinical narrative: Swelling and tender to touch in left arm and some swelling in periorbital.
Age: 1.01
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Received DTAP/HBV/IPV #3, HIB #3, Hep. A #1 P13, Varicella #1, MMR #1 on 5/19/10. Mother states had fever on 5/30/10 103 degrees F. Gave MOTRIN. On 5/31/10 had rash on face and body took to ER. 6/1/10 Child afebrile rash receding.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discolouration, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Injection area swelled to size of golf ball, became hot, hard and discolored.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: Immediate urticarial rxn 3cm x 1cm at MMR site. No anaphylaxis (-) cyl.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction
Clinical narrative: Increased Rxn 1 cm x 1 cm immediately after immunization MMR. No anaphylaxis no cough.
Age: 56.0
Sex: M
Vaccine: RAB
Symptoms: Animal bite, Cellulitis, Surgery
Clinical narrative: Initial report received from the pharmacist on 20 May 2010: This patient was bitten by a skittish house cat in the left hand on 16 May 2010. He began to develop cellulitis around the wound and for the treatment of which the patient was hospitalized on 18 May 2010. On 19 May 2010 (at around 10:00), the patient was vaccinated with first dose RABAVERT (batch number: unknown) dose unspecified intramuscularly in the left arm. On 19 May 2010 (10:30), the patient also received two injections of Human Rabies immune Globulin, total 06 ml in the right arm. On 19 May 2010 (at 14:00), the patient went in to the surgery for treatment of cellulitis at wound site (left hand). It was reported that, during surgery 05 mg HRIG were infiltrated around the wound & an additional 1.6 ml of HRIG was administered intramuscularly to the left arm, which was the same as the RABAVERT administration. The outcome of the event surgery was not reported.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Oedema peripheral, Pruritus generalised, Pyrexia, Urticaria
Clinical narrative: Mother called 6/1/10 reporting that childs hands were swollen. Hives, itching all over body and poss. fever. She reports onset as 5/30/10.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Body pain followed by outbreak of shingles by next morning.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Crying, Diarrhoea, Pain
Clinical narrative: Continued colic for more than 2 weeks. Loose motion and the child crying in extreme pain.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pruritus, Urticaria
Clinical narrative: Patient states that she woke up this morning with redness and extensive swelling to left arm, with hives and itching.
Age: 51.0
Sex: F
Vaccine: JEV1
Symptoms: Axillary pain, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Redness, induration and pain at site of injection (left arm); muscle aches, headache lasted approximately 1 week. As of 06/01/2010 still have slight tenderness on palpation at site of injection and stiffness of left side of neck and pain in axillary muscles on the left.
Age: 51.0
Sex: F
Vaccine: JEV1
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: Redness, induration and pain at site of injection (left arm); muscle aches, headache lasted approximately 1 week. As of 06/01/2010 still have slight tenderness on palpation at site of injection and stiffness of left side of neck and pain in axillary muscles on the left.