chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Drug exposure during pregnancy, Erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain from shoulder to forearm since injec yesterday. Pt eval this am, skin mildly elev at site - diameter of a lemon. No redness @ site (+) warm. Streaking red on shoulder and forearm, pt advised BENADRYL she is pregn.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pregnancy
Clinical narrative: Pain from shoulder to forearm since injec yesterday. Pt eval this am, skin mildly elev at site - diameter of a lemon. No redness @ site (+) warm. Streaking red on shoulder and forearm, pt advised BENADRYL she is pregn.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dyspnoea, Influenza, Pyrexia
Clinical narrative: Patient had some trouble breathing, fever chills, diarrhea, flu symptoms started 3 hours after vaccination. Lasted a couple of days.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: She received influenza  vaccine 10/1/10 at around 1000/AM. 10/5/10 notified us at appt the she had had a reaction - 10/1/10 started at 9pm with red, swollen, warm area size of quarter then radiated down upper (R) arm about 1"-2". She then developed chills/aches all over/weakness and here is list of temp 1100/PM - 100.0 degrees, 102.1, 102.6, 103.4, 103.8, 102.9 330/AM 100.5  - She took TYLENOL  alt with ASA and fever finally came down. 504AM 99.9 - 97.6.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: She received influenza  vaccine 10/1/10 at around 1000/AM. 10/5/10 notified us at appt the she had had a reaction - 10/1/10 started at 9pm with red, swollen, warm area size of quarter then radiated down upper (R) arm about 1"-2". She then developed chills/aches all over/weakness and here is list of temp 1100/PM - 100.0 degrees, 102.1, 102.6, 103.4, 103.8, 102.9 330/AM 100.5  - She took TYLENOL  alt with ASA and fever finally came down. 504AM 99.9 - 97.6.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Blood pressure decreased, Dizziness, Feeling cold, Gaze palsy, Pallor
Clinical narrative: Legs were elevated & ice pack applied behind neck. Approx. 8mins after vaccine administration, mother notified me that the pt. stated that she felt like she was going to faint & was dizzy. I noticed the pt. in the chair shaking, eyes were rolling back and appeared pale. EMS called by this nurse. Once she became conscious & alert x3 glucose was given by another nurse & V/S were taken. Pt. complained of being cold. EMS arrived & evaluated pt. Sent home with mother.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Tremor
Clinical narrative: Legs were elevated & ice pack applied behind neck. Approx. 8mins after vaccine administration, mother notified me that the pt. stated that she felt like she was going to faint & was dizzy. I noticed the pt. in the chair shaking, eyes were rolling back and appeared pale. EMS called by this nurse. Once she became conscious & alert x3 glucose was given by another nurse & V/S were taken. Pt. complained of being cold. EMS arrived & evaluated pt. Sent home with mother.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: About 4 inch diameter red raised circle at injection site. Pt went do Dr.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: 3 x 5" erythema with 2 blisters around site of injection on (R) arm. 2 x 3" erythema around site of injection on (L) arm.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: Rash
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Pyrexia, Rhinorrhoea
Clinical narrative: felt awful, fever, runny nose
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Drug exposure during pregnancy, Dyspnoea, Palatal oedema, Pharyngeal oedema
Clinical narrative: Pharyngeal and uvular edema, Difficulty breathing
Age: 58.0
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Cough, Fatigue, Rhinorrhoea, Throat irritation
Clinical narrative: Runny nose, scratchy throat, cough, fatigue.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Diarrhoea, Rash, Rhinorrhoea
Clinical narrative: Paient experienced adverse effect possibly from Afluria flu shot: rash on hands and arms, loose stool, cough and runny nose beginning the day after receiving flu shot.  When she contacted us on 10/04/10 the symptoms of rash were subsiding.  Told patient she could use Benadryl if needed but she felt it was getting better, she just wanted the event reported.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Heart rate increased, Laboratory test, Pharyngeal erythema
Clinical narrative: returned to clinic and reported feeling increased heart rate and hoarseness in voice, front area of throat was reddened
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Hot flush, Hyperhidrosis
Clinical narrative: Excelerated heart rate, light headedness, hot flashes, sweating, extremely blood shot eyes, difficulty taking a deep breath.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia
Clinical narrative: Excelerated heart rate, light headedness, hot flashes, sweating, extremely blood shot eyes, difficulty taking a deep breath.
Age: 58.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Pyrexia
Clinical narrative: Fever and chills for several hours.   A mild fever the following day.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Face injury, Fall, Head injury, Loss of consciousness
Clinical narrative: Patient had vaccine fully administered and retracted from skin and reported that the vaccine went well.  As I was disposing the needle in the sharps container he passed out while still seated and fell to the floor hitting his head and nose on the floor.  He was unconscious for appr. 10 sec before he came to.  EMS arrived within 5 minutes of adverse reaction.
Age: 22.0
Sex: F
Vaccine: HPV4, MMR, PPV, TDAP, VARCEL
Symptoms: Erythema, Malaise, Pain in extremity, Skin warm
Clinical narrative: PT. WOKE UP WITH 2 SORE ARMS. LARGE HOT VERY RED CLEARLY DEFINED AREAS ON UPPER OUTER ARMS. BOTH ARMS SORE. FEELS MALAISE.
Age: 55.0
Sex: F
Vaccine: FLU(H1N1), FLU3, PPV
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Tenderness, swelling, erythema at injection site.  Myalgia, fatigue, nausea.
Age: 55.0
Sex: F
Vaccine: FLU(H1N1), FLU3, PPV
Symptoms: Nausea
Clinical narrative: Tenderness, swelling, erythema at injection site.  Myalgia, fatigue, nausea.
Age: 7.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Erythema, Induration, Oedema peripheral, Pruritus
Clinical narrative: Upper arm severely swollen, hard, red and itchy for 36 hours.  Gave Benadryl and Tylenol.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt received influenza vaccine in left deltoid on 10/05/2010. The next morning mom noticed a low grade fever and the left upper arm was swollen, red, warm and pruritic. Pt was brought to ED after sx did not resolve with Motrin. Pt was given IV cefazolin and PO Benadryl but area of inflammation continued to spread. Pt switched to IV clinda.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Pt received influenza vaccine in left deltoid on 10/05/2010. The next morning mom noticed a low grade fever and the left upper arm was swollen, red, warm and pruritic. Pt was brought to ED after sx did not resolve with Motrin. Pt was given IV cefazolin and PO Benadryl but area of inflammation continued to spread. Pt switched to IV clinda.
Age: 25.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Injection site erythema, Rash erythematous, Rash pruritic
Clinical narrative: Redness at injection site of yellow fever vaccine on upper left arm.  Over the next 36 hours started to get red areas on shoulder, face, and back.  Described as red bumps resembling acne.  Now bumps are starting to itch.  No other symptoms, no DIB.  Will be starting to take Benadryl for the itching.
Age: 36.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red swollen raised bump size of grapefruit on upper arm where shot was given.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Acne, Rash, Rash pruritic
Clinical narrative: Patient had a rash break out on his chest, it is itchy, and appears to be many pimples just starting out, states that he has never had any type of acne of this magnitude.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site pruritus, Injection site swelling, Neck pain, Posture abnormal
Clinical narrative: NOTICE SMALL AMOUNT OF SWELLING AT THE INJECTION. OPN 10/05/2010 LOT MORE SWELLING AND ITCHING REMOVED BANDAID AND GAVE TYLENOL. ALSO NOTICE PAIN ON LEFT SIDE OF NECK AND UNABLE TO HOLD IN AND UPRIGHT POSITION LEANING TO THE LEFT. AFTER TALKING WITH NURSE ADVISE TO TAKE CHILD TO E.R SINCE THEY DID NOT HAVE A PRIMARY DOCTOR TO GO TO FOR EVALUATION.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Induration, Oedema peripheral, Skin warm
Clinical narrative: Massive swelling, from the shoulder to just above elbow. Extreme heat and hardness in the area.
Age: 44.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Given Advil and rest, Possible allergic reaction
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Mom noticed left arm was very red and swollen, warm to the touch day after injection. Child stated it did not hurt. This office was able to evaluate the area. Child appeared in no distress. Area was very red, swollen, warm and somewhat hard to the touch. No lymphedema in armpit area.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pustule, Injection site warmth, Muscle spasms
Clinical narrative: MOTHER OF PARENTS STATES THAT 1 DAY AFTER INJECTION, DAUGHTER COMPLAINED OF PAIN AT INJECTION SITE. MOTHER STATES THAT SHE NOTICED REDNESS AT SITE WITH "PIMPLE" ON INJECTION SITE. MOTHER STATES SITE IS WARM TO TOUCH. MOTHER STATES THAT CHILD WAS AWAKENED IN TEARS WITH COMPLAINTS OF RT LEG CRAMPS AT APPROX 12:00AM TODAY. STATES THAT CHILD WAS FEELING NAUSEATED TODAY (10/7/10). MOTHER DENIES FEVER.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea, Tearfulness
Clinical narrative: MOTHER OF PARENTS STATES THAT 1 DAY AFTER INJECTION, DAUGHTER COMPLAINED OF PAIN AT INJECTION SITE. MOTHER STATES THAT SHE NOTICED REDNESS AT SITE WITH "PIMPLE" ON INJECTION SITE. MOTHER STATES SITE IS WARM TO TOUCH. MOTHER STATES THAT CHILD WAS AWAKENED IN TEARS WITH COMPLAINTS OF RT LEG CRAMPS AT APPROX 12:00AM TODAY. STATES THAT CHILD WAS FEELING NAUSEATED TODAY (10/7/10). MOTHER DENIES FEVER.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Diarrhoea
Clinical narrative: mild diarrhea
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: SWOLLEN, CONSISTENTLY RED AREA ABOUT 4 INCHES BY 8 INCHES
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Limb discomfort, Pain in extremity
Clinical narrative: On 10/6/10 received phone call from patient.  Vaccine given 8/23/10.  States arm "sore and irritated" (especially at night) for past 2-3 weeks.  States "Shoulder and arm go numb from time to time".  States this started "a week or two ago".  When questioned about time before he believes symptoms began, states can't remember any problems soon after the vacacine was given.  Patient poor historian.  Encouraged to follow-up with PCP.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Blood creatine phosphokinase MB, Chills, Diarrhoea, Differential white blood cell count
Clinical narrative: nausea, diarrhea, vomiting, chills, body aches and severe pains to hips and knees, sweats
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Electroencephalogram, Full blood count, Hyperhidrosis, Lipase, Metabolic function test
Clinical narrative: nausea, diarrhea, vomiting, chills, body aches and severe pains to hips and knees, sweats
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain, Troponin I, Vomiting
Clinical narrative: nausea, diarrhea, vomiting, chills, body aches and severe pains to hips and knees, sweats
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pharyngeal erythema, Pyrexia, Stomatitis
Clinical narrative: Father reports that patient developed a fever of 102.6 and had redness and swelling at the site of the injection. He reported swelling was the size of a softball. He also developed sores in his mouth. The child had a red throat. He was prescribed Keflex 250mg QID.
Age: 4.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Type III immune complex mediated reaction
Clinical narrative: Awoke next morning with redness and swelling (tennis ball size) on arm at site of injection of Prevnar 13 and flu shot.  No fever.  No antibiotics administered.  Nearly resolved by 10/7/10 in am.  Appeared to be arthus reaction to me. (I'm MD practicing clinical immunology)
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site swelling
Clinical narrative: ALLERGIC REACTION TO PNEUMOVAX. SWELLING OF INJECTION SITE. REQUIRED EMERGENCY VISIT. GIVEN MEDICATION TO COUNTER THE ALLERGIC REACTION.
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chills, Dizziness, Injection site rash, Pain
Clinical narrative: rash at site, fever, chills, dizziness, body ache and cellulitis
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: rash at site, fever, chills, dizziness, body ache and cellulitis
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Axillary pain, Blood pressure increased, Body temperature decreased
Clinical narrative: Shortness of breath, swelling of nasal tissues, dizziness, slight nausea, itchiness all over body, significant soreness in shoulder muscle where vaccination was administered, swollen & sore gland in armpit of shoulder in which vaccination was administered, weakness & tremors, soreness in joints, lowered body temperature (96.4°), chills / cold sweats, normal pulse but slightly elevated blood pressure.  Symptoms have persisted for 60 hours as of the completion of this report, but seem to be getting a little bit less severe.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cold sweat, Dizziness, Dyspnoea, Injection site pain
Clinical narrative: Shortness of breath, swelling of nasal tissues, dizziness, slight nausea, itchiness all over body, significant soreness in shoulder muscle where vaccination was administered, swollen & sore gland in armpit of shoulder in which vaccination was administered, weakness & tremors, soreness in joints, lowered body temperature (96.4°), chills / cold sweats, normal pulse but slightly elevated blood pressure.  Symptoms have persisted for 60 hours as of the completion of this report, but seem to be getting a little bit less severe.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy, Nasal congestion, Nausea, Pruritus generalised, Tremor
Clinical narrative: Shortness of breath, swelling of nasal tissues, dizziness, slight nausea, itchiness all over body, significant soreness in shoulder muscle where vaccination was administered, swollen & sore gland in armpit of shoulder in which vaccination was administered, weakness & tremors, soreness in joints, lowered body temperature (96.4°), chills / cold sweats, normal pulse but slightly elevated blood pressure.  Symptoms have persisted for 60 hours as of the completion of this report, but seem to be getting a little bit less severe.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Pt had redness swollen arm, and warmth.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Induration, Pain in extremity
Clinical narrative: arm hurt and was "hard"
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Drug exposure during pregnancy, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: developed 3 inch diameter raised, hard, red lump at injection site that was hot to the touch and very painful - condition persists after 2 days
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site warmth
Clinical narrative: developed 3 inch diameter raised, hard, red lump at injection site that was hot to the touch and very painful - condition persists after 2 days
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Generalised erythema, Swelling
Clinical narrative: erythema generalized, swelling, dizziness
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Nausea, Nystagmus, Vertigo, Vision blurred
Clinical narrative: Blurred vision while looking at computer screen, nystagmus, nausea, vertigo & headache. 48 hours after vaccination nausea, vertigo and headache still persist.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: Per pt, within 30 minutes after shot he couldn't raise his left arm.  Pt is still experiencing this effect after 2 weeks.
Age: 9.0
Sex: M
Vaccine: DTAP, FLU3, HEP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Grand mal convulsion
Clinical narrative: Generalized tonic clonic seizure. No recorded fever. Lasted 5-10 minutes, spontaneously resolved.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Influenza like illness, Vomiting
Clinical narrative: The morning following vaccination, the patient had sudden onset of severe vomiting, dizziness, and flu type symptoms that were severe enough to call the EMT.  It was the EMT that stated he thought it was related to the flu vaccine.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Nausea, Pain in extremity
Clinical narrative: Patient said that her arm was in pain two days after she received the flu shot. She experienced nausea and numbness in her left arm on 10/03/2010 and went to the local ER where they gave her pain medication and had her put ice on the arm.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Dysstasia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Immediately upon awaking and trying to stand up, I noticed my legs and hurt and it was unpleasant to stand up. Later I had a fever of 100+, was very achy all over and really had a very hard day.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Confusional state, Fall, Head injury, Loss of consciousness
Clinical narrative: Patient passed out and fell and hit his head on the floor, and became unconscious for about 2 minutes.  Paramedics were called to the scene.  Patient regained consciousness but continued to be confused.  He did not display any signs of localized allergic or anaphylactic reactions.  He was taken to local hospital for evaluation.  It was believed that the vaccine did not cause the loss of consciousness, but possibly low blood pressure as reported by the patient the next day.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt complains of mild arm pain that is still present 10 days post-injection.  Also complains of difficulty raising arm above shoulder.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: Came down with a real bad headache at work. By the time I got home it was getting worse. Laid down fell asleep, when I woke up the headache wasn't as bad. But I sat up and I was really dizzy, then made it to the bathroom had diarrhea and was nauseous. Then had a low grade fever and chills. I think the worse part of this was the dizziness this has lasted 2 days. I started getting the flu shots in 2005 after learning I have MS. Even though I have MS I have never been sick from any of the shots before this. I don't know if it was the certain strain in this years vaccine or not. Just thought you should know this info it may help you. Thank you.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: No reaction on previous exposure to drug, Pyrexia
Clinical narrative: Came down with a real bad headache at work. By the time I got home it was getting worse. Laid down fell asleep, when I woke up the headache wasn't as bad. But I sat up and I was really dizzy, then made it to the bathroom had diarrhea and was nauseous. Then had a low grade fever and chills. I think the worse part of this was the dizziness this has lasted 2 days. I started getting the flu shots in 2005 after learning I have MS. Even though I have MS I have never been sick from any of the shots before this. I don't know if it was the certain strain in this years vaccine or not. Just thought you should know this info it may help you. Thank you.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Pt experienced a red area about 2 inches below the shot that is warm to the touch.
Age: 1.02
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Influenza A virus test negative, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Fever equal or above 104 F for 1-2 days needing ER visit and admitted to hospital 3 days.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Impaired work ability, Inappropriate affect, Logorrhoea, Speech disorder
Clinical narrative: Received influenza vaccination. Later in day became (according to co-workers) rambling in speech; completed a report wrong and otherwise seemed increased "happy" and very "talkative".
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hot flush, Hyperhidrosis, Pallor
Clinical narrative: After receiving shot the patient stood for a minute then while talking became lightheaded and sweaty. She stated she was on Phentermine and not eaten since 1:00pm so I ran to get O.J. thinking she was hypoglycemic. After another two minutes she lost color in her face and was getting hot flashes, 911 was called. BP approximately 110/70 after hot flash. Ambulance arrive approximately 7:58pm.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: 2 days after administration of FLUZONE, noted to have quarter sized, red area below injection site.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Injection site pain, Pain in extremity
Clinical narrative: Patient reports extreme pain in left arm from deltoid down to hand 2 or 3 times the pain resonated to the pectoral area. At 6pm the patient reported that the pain was beginning to lessen in intensity.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Skin warm
Clinical narrative: Hot to touch. Red from injection site to elbow.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Heart rate increased, Hyperhidrosis
Clinical narrative: Patient was given an influenza vaccine at approx 10:00 a.m on 10/6/10. She started feeling dizzy, clammy/sweating, and rapid heart beat around 4:00 p.m on 10/6/10. She was give 2 tables spoons of BENADRYL and vitals were monitored.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling at the sites of injection (PNEUMOVAX and flu) and pain to the site of injection.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia facial
Clinical narrative: Employee stated her head felt "full" and reported some numbness to the right side of face. Symptoms resolved after BENADRYL and EPI was given.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, MNQ
Symptoms: Injection site swelling, Tenderness
Clinical narrative: After receiving vaccines, (R) deltoid became swollen, 1 inch of circumference more than (L). Arm was tender.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Swollen injection site. Stiff arm. Redness spreading. Cellulitis. Steroid antibody.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Erythema, Infection, Injected limb mobility decreased, Malaise
Clinical narrative: Patient received both vaccines (in two different arms) on 10/3/10. On Monday, during the night, she had a fever of 102 degrees, and felt very sick. Went to Dr. on Tues. and Dr. felt it was from vaccines. By Wednesday fever went up to 103.4 and arm (left) was red and swollen. Difficult to move arm. Dr. felt infection from injection.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pyrexia, Vaccination complication
Clinical narrative: Patient received both vaccines (in two different arms) on 10/3/10. On Monday, during the night, she had a fever of 102 degrees, and felt very sick. Went to Dr. on Tues. and Dr. felt it was from vaccines. By Wednesday fever went up to 103.4 and arm (left) was red and swollen. Difficult to move arm. Dr. felt infection from injection.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large area of swelling, redness in upper arm - given Rx for antibiotic.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting after receiving flu shot on 10-6-10 from afternoon until evening.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abscess, Cellulitis, Feeling hot, Swelling
Clinical narrative: Patient called pharmacy on 9.18.10 to notify RPH about swelling and a "Hrat" feeling she was experiencing. She was advised by RPH on duty to see a physician at urgent care.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Haematochezia
Clinical narrative: Blood seen in stool the night of the vaccine. Same thing happened to older brother 2 days after receiving Rota vaccine.
Age: 49.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: Pruritus, erythema, & edema at site of injection. Additionally, pt reports lightheadedness.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: ZOSTAVAX given 9/28/2010 - Shingles break out 10/3/10 (R) T4 dermatome.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a physician and described the occurrence of arm pain in a 66-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included NEURONTIN. On 21 September 2010 at 15:00 the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). On 23 September 2010, 2 days after vaccination with FLULAVAL, the subject experienced arm pain. The subject described the pain as severe. The pain had persisted unabated for 4 days and was radiating down the ulna. The physician considered the event was clinically significant (or requiring intervention). The subject was treated with ANALGESIA. At the time of reporting the event was worse. The physician considered the event was probably related to vaccination with FLULAVAL>
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Body temperature increased, Chills, Hypersensitivity, Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 October 2010 at 07:00 the subject received a dose of FLULAVAL (unknown route, right arm). On 4 October 2010, less than one day after vaccination with FLULAVAL, the subject experienced fever (101.6), chills and body pain. The events were reported as a systemic reaction. The subjects symptoms required her to leave work 2 hours early. Healthcare professional considered the events were disabling. At the time of reporting the events were improved. The healthcare professional also reported 7 additional subjects who had experienced adverse events of injection site tenderness, injection site redness and hotness at injection site following vaccination with FLULAVAL (see case IDs A0885121A, A0885268A - A0885273A for more information).
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 October 2010 at 07:00 the subject received a dose of FLULAVAL (unknown route, right arm). On 4 October 2010, less than one day after vaccination with FLULAVAL, the subject experienced fever (101.6), chills and body pain. The events were reported as a systemic reaction. The subjects symptoms required her to leave work 2 hours early. Healthcare professional considered the events were disabling. At the time of reporting the events were improved. The healthcare professional also reported 7 additional subjects who had experienced adverse events of injection site tenderness, injection site redness and hotness at injection site following vaccination with FLULAVAL (see case IDs A0885121A, A0885268A - A0885273A for more information).
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Autopsy, Death, Sudden infant death syndrome
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA and from Glaxo Smith Kline (manufacturer number AR-09-12).  An 8 week old male patient with no pertinent medical history and preexisting illness was vaccinated with the second dose of RECOMBIVAX HB (Lot # 659669/0062X) IM in the left leg on 16-APR-2009.  Other concomitant vaccines included a first dose of PENTACEL (Lot #C3279AA) IM in the right leg; a first dose of ROTARIX (Lot # A41CA693A) oral and a first dose of PREVNAR (Lot # D24322) IM in the left leg, all of them administered also on 16-APR-2009.  It was reported that on 21-APR-2009 the patient experienced Sudden Infant Death Syndrome.  On 22-JUN-2009 the autopsy report received revealed (DOS) 22-APR-2009.  The cause of death was SIDS.  The patient was reported to have died at 07:15 AM on 21-APR-2009.  Manner of death was reported as natural.  A standard lot check investigation has been finalized.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot me the requirements of the Research Center and was released.  This was originally reported by a physician.  Additional information has been requested.  The VAERS ID # is 344816.
Age: 22.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Abdominal infection, Abdominal pain, Blood pressure decreased
Clinical narrative: Initial report received via Regulatory Authority (VAERS no. 375852) on 30 Sep 2010:  This patient had medical history of brain neoplasm, which was removed and rendered damage to her pituitary gland.  The patient received a dose of FLUVIRIN (H1N1 influenza virus vaccine, batch number 102044P1) intramuscularly, 0.5 ml on 03 Dec 2009.  The patient experienced a sharp pain on her right abdomen that persistently grew worse on 17 Dec 2009.  The patient's blood pressure dropped to 82/42 (units unspecified) on 18 Dec 2009.  She was advised to go to emergency room and there the patient was found to have a large amount of fluid in her abdomen (size of sauce jar).  It was reported that, the attending physician had never seen anything like this before and said that it could be either due to viral infection or possibly linked to the vaccination.  The outcome of the events was subsiding but not completely recovered.
Age: 22.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Abdominal pain, Blood pressure decreased, Localised intraabdominal fluid collection, Pain
Clinical narrative: Initial report received via Regulatory Authority (VAERS no. 375852) on 30 Sep 2010:  This patient had medical history of brain neoplasm, which was removed and rendered damage to her pituitary gland.  The patient received a dose of FLUVIRIN (H1N1 influenza virus vaccine, batch number 102044P1) intramuscularly, 0.5 ml on 03 Dec 2009.  The patient experienced a sharp pain on her right abdomen that persistently grew worse on 17 Dec 2009.  The patient's blood pressure dropped to 82/42 (units unspecified) on 18 Dec 2009.  She was advised to go to emergency room and there the patient was found to have a large amount of fluid in her abdomen (size of sauce jar).  It was reported that, the attending physician had never seen anything like this before and said that it could be either due to viral infection or possibly linked to the vaccination.  The outcome of the events was subsiding but not completely recovered.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Electromyogram, Muscular weakness, Myalgia
Clinical narrative: Pt received influenza vacc on 10/28/2009. Developed myalgias muscle weakness and hospitalized on Dec 16, 2009 - Jan 19, 2010. EMG proved G-B syndrome. No speech or breathing problems. Upper extremities affected more than lower. Pain required opioids. Had IV immunoglobulin injections. Attending rehab 3 days/week.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness, Myalgia
Clinical narrative: Pt received influenza vacc on 10/28/2009. Developed myalgias muscle weakness and hospitalized on Dec 16, 2009 - Jan 19, 2010. EMG proved G-B syndrome. No speech or breathing problems. Upper extremities affected more than lower. Pain required opioids. Had IV immunoglobulin injections. Attending rehab 3 days/week.
Age: 72.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea, Nausea Vomiting
Age: 72.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhea, Nausea Vomiting
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Headache, Hypoaesthesia, Injection site pain, Nausea
Clinical narrative: Information has been received for the pregnancy registry for GARDASIL from a registered nurse, who on an unspecified date was inadvertently vaccinated with the third dose of GARDASIL while pregnant. The patient did not realize that she was pregnant at the time, however found out after she received the 3rd shot that she was indeed pregnant. Follow-up information was received from the approximately 26 year old registered nurse, via telephone call who reported that her last menstrual period was on 14-MAY-2009. On 01-JUN-2009, the patient received the third dose of GARDASIL at a different provider's office. The patient found out she was pregnant on 19-JUN-2009. She denied any significant medical history and said there was no concurrent medications. She said she didn't "feel right" during her pregnancy. When asked for clarification she stated she had a lot of nausea and was diagnosed with Hyperemesis Gravidarium, and was treated with phenergan. The patient was diagnosed with Polyhydramnios but did not have gestational diabetes. She was referred to a Perinatologist at 28 weeks who "discussed that there could possibly be an esophageal problem" with this condition. On 04-JAN-2010, at 32 weeks from her LMP, the patient gave birth to a male baby who experienced esophageal atresia, imperforate anus, tethered spinal cord and flipped aortic arch. Follow-up information was received from a pediatrician and Pediatric medical records and the following experience was identified: The 25-year-old married gravida 2, para 0, now para 1 woman with a history of 1 spontaneous abortion and 1 living preterm infant. She had history of Chlamydia which was treated. Mother was O positive, serology nonreactive, rubella status immune, hepatitis B surface antigen negative, HIV nonreactive, beta strep status unknown. On 03-JAN-2010 the mother had an ultrasound day before indicating polyhydramnios. On 04-JAN-2010, at 32-3/7 week of gestation, the mother delivered a male infant, 1945 gm, at hospital. The pregnancy was complicated by premature rupture of membranes at 12:30 on day of birth on 04-JAN-2010. She presented with spontaneous preterm labor, spontaneous rupture of membranes of 2 hours prior to delivery. The amniotic fluid was increased. Mother did receive betamethasone x1. A primary C-section was performed for decreased fetal heart tones and breech presentation. Time of birth was 8:32 a.m. on 04-JAN-2010. Apgars awarded were 5 and 9. Mother and infant required oxygen and infant required CPAP and assisted bag-mask ventilation. The infant was intubated at hospital and transferred to another hospital. Upon internal review, C-section for decreased fetal heart tones and breech presentation were considered to be other important medical events. The baby's experience has been captured in WAES 1006USA04079B1. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Paraesthesia, Syncope, Vomiting
Clinical narrative: Information has been received for the pregnancy registry for GARDASIL from a registered nurse, who on an unspecified date was inadvertently vaccinated with the third dose of GARDASIL while pregnant. The patient did not realize that she was pregnant at the time, however found out after she received the 3rd shot that she was indeed pregnant. Follow-up information was received from the approximately 26 year old registered nurse, via telephone call who reported that her last menstrual period was on 14-MAY-2009. On 01-JUN-2009, the patient received the third dose of GARDASIL at a different provider's office. The patient found out she was pregnant on 19-JUN-2009. She denied any significant medical history and said there was no concurrent medications. She said she didn't "feel right" during her pregnancy. When asked for clarification she stated she had a lot of nausea and was diagnosed with Hyperemesis Gravidarium, and was treated with phenergan. The patient was diagnosed with Polyhydramnios but did not have gestational diabetes. She was referred to a Perinatologist at 28 weeks who "discussed that there could possibly be an esophageal problem" with this condition. On 04-JAN-2010, at 32 weeks from her LMP, the patient gave birth to a male baby who experienced esophageal atresia, imperforate anus, tethered spinal cord and flipped aortic arch. Follow-up information was received from a pediatrician and Pediatric medical records and the following experience was identified: The 25-year-old married gravida 2, para 0, now para 1 woman with a history of 1 spontaneous abortion and 1 living preterm infant. She had history of Chlamydia which was treated. Mother was O positive, serology nonreactive, rubella status immune, hepatitis B surface antigen negative, HIV nonreactive, beta strep status unknown. On 03-JAN-2010 the mother had an ultrasound day before indicating polyhydramnios. On 04-JAN-2010, at 32-3/7 week of gestation, the mother delivered a male infant, 1945 gm, at hospital. The pregnancy was complicated by premature rupture of membranes at 12:30 on day of birth on 04-JAN-2010. She presented with spontaneous preterm labor, spontaneous rupture of membranes of 2 hours prior to delivery. The amniotic fluid was increased. Mother did receive betamethasone x1. A primary C-section was performed for decreased fetal heart tones and breech presentation. Time of birth was 8:32 a.m. on 04-JAN-2010. Apgars awarded were 5 and 9. Mother and infant required oxygen and infant required CPAP and assisted bag-mask ventilation. The infant was intubated at hospital and transferred to another hospital. Upon internal review, C-section for decreased fetal heart tones and breech presentation were considered to be other important medical events. The baby's experience has been captured in WAES 1006USA04079B1. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Amniotic fluid volume increased, Blood HIV RNA below assay limit, Breech presentation, Caesarean section, Complication of pregnancy
Clinical narrative: Information has been received for the pregnancy registry for GARDASIL from a registered nurse, who on an unspecified date was inadvertently vaccinated with the third dose of GARDASIL while pregnant. The patient did not realize that she was pregnant at the time, however found out after she received the 3rd shot that she was indeed pregnant. Follow-up information was received from the approximately 26 year old registered nurse, via telephone call who reported that her last menstrual period was on 14-MAY-2009. On 01-JUN-2009, the patient received the third dose of GARDASIL at a different provider's office. The patient found out she was pregnant on 19-JUN-2009. She denied any significant medical history and said there was no concurrent medications. She said she didn't "feel right" during her pregnancy. When asked for clarification she stated she had a lot of nausea and was diagnosed with Hyperemesis Gravidarium, and was treated with phenergan. The patient was diagnosed with Polyhydramnios but did not have gestational diabetes. She was referred to a Perinatologist at 28 weeks who "discussed that there could possibly be an esophageal problem" with this condition. On 04-JAN-2010, at 32 weeks from her LMP, the patient gave birth to a male baby who experienced esophageal atresia, imperforate anus, tethered spinal cord and flipped aortic arch. Follow-up information was received from a pediatrician and Pediatric medical records and the following experience was identified: The 25-year-old married gravida 2, para 0, now para 1 woman with a history of 1 spontaneous abortion and 1 living preterm infant. She had history of Chlamydia which was treated. Mother was O positive, serology nonreactive, rubella status immune, hepatitis B surface antigen negative, HIV nonreactive, beta strep status unknown. On 03-JAN-2010 the mother had an ultrasound day before indicating polyhydramnios. On 04-JAN-2010, at 32-3/7 week of gestation, the mother delivered a male infant, 1945 gm, at hospital. The pregnancy was complicated by premature rupture of membranes at 12:30 on day of birth on 04-JAN-2010. She presented with spontaneous preterm labor, spontaneous rupture of membranes of 2 hours prior to delivery. The amniotic fluid was increased. Mother did receive betamethasone x1. A primary C-section was performed for decreased fetal heart tones and breech presentation. Time of birth was 8:32 a.m. on 04-JAN-2010. Apgars awarded were 5 and 9. Mother and infant required oxygen and infant required CPAP and assisted bag-mask ventilation. The infant was intubated at hospital and transferred to another hospital. Upon internal review, C-section for decreased fetal heart tones and breech presentation were considered to be other important medical events. The baby's experience has been captured in WAES 1006USA04079B1. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug exposure during pregnancy, Feeling abnormal, Foetal disorder, Hepatitis B test negative, Hyperemesis gravidarum
Clinical narrative: Information has been received for the pregnancy registry for GARDASIL from a registered nurse, who on an unspecified date was inadvertently vaccinated with the third dose of GARDASIL while pregnant. The patient did not realize that she was pregnant at the time, however found out after she received the 3rd shot that she was indeed pregnant. Follow-up information was received from the approximately 26 year old registered nurse, via telephone call who reported that her last menstrual period was on 14-MAY-2009. On 01-JUN-2009, the patient received the third dose of GARDASIL at a different provider's office. The patient found out she was pregnant on 19-JUN-2009. She denied any significant medical history and said there was no concurrent medications. She said she didn't "feel right" during her pregnancy. When asked for clarification she stated she had a lot of nausea and was diagnosed with Hyperemesis Gravidarium, and was treated with phenergan. The patient was diagnosed with Polyhydramnios but did not have gestational diabetes. She was referred to a Perinatologist at 28 weeks who "discussed that there could possibly be an esophageal problem" with this condition. On 04-JAN-2010, at 32 weeks from her LMP, the patient gave birth to a male baby who experienced esophageal atresia, imperforate anus, tethered spinal cord and flipped aortic arch. Follow-up information was received from a pediatrician and Pediatric medical records and the following experience was identified: The 25-year-old married gravida 2, para 0, now para 1 woman with a history of 1 spontaneous abortion and 1 living preterm infant. She had history of Chlamydia which was treated. Mother was O positive, serology nonreactive, rubella status immune, hepatitis B surface antigen negative, HIV nonreactive, beta strep status unknown. On 03-JAN-2010 the mother had an ultrasound day before indicating polyhydramnios. On 04-JAN-2010, at 32-3/7 week of gestation, the mother delivered a male infant, 1945 gm, at hospital. The pregnancy was complicated by premature rupture of membranes at 12:30 on day of birth on 04-JAN-2010. She presented with spontaneous preterm labor, spontaneous rupture of membranes of 2 hours prior to delivery. The amniotic fluid was increased. Mother did receive betamethasone x1. A primary C-section was performed for decreased fetal heart tones and breech presentation. Time of birth was 8:32 a.m. on 04-JAN-2010. Apgars awarded were 5 and 9. Mother and infant required oxygen and infant required CPAP and assisted bag-mask ventilation. The infant was intubated at hospital and transferred to another hospital. Upon internal review, C-section for decreased fetal heart tones and breech presentation were considered to be other important medical events. The baby's experience has been captured in WAES 1006USA04079B1. No further information is available.