chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Irritability, Lymphadenopathy, Rectal haemorrhage, Thrombosis, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning her 17 week old niece with no known pertinent medical history and drug reactions/allergies who had been vaccinated with a first dose of ROTATEQ (lot# not reported) at 8 weeks of age. A couple of days after the first dose, the patient developed slight, sporadic rectal bleeding. On 21-JUL-2010, the patient was vaccinated with a second dose of ROTATEQ (lot# not reported). On 21-JUL-2010, immediately after receiving the second dose (reported as "in the evening"), the baby had blood in the stools; the bleeding has continued and she had passed two clots, clots ranged from pea to dime size; in the week preceding this report, there were clots every day and seven BMs without pus per day. No other significant symptoms; baby was sometimes irritable and sometimes looked like she had gas pain. Initially it was thought there was a milk allergy, so diet was changed and baby continued with breast milk; allergy testing came back negative; blood work showed an increased AST (56) and an increased potassium level; baby now was on a "special formula". Colonoscopy performed on 25-AUG-2010; according to the registered nurse, the physician said the results were the "worse he had seen in 30 years"; biopsy results pending. She had been diagnosed with severe ulcerative colitis. Unspecified medical attention was sought. The patient did not recover from severe ulcerative colitis. On 27-AUG-2010, additional information was received from a licensed practical nurse who added that the first dose of ROTATEQ was given on 21-MAY-2010, lot # 665272/0203Z, along with a dose of PREVNAR, PENTACEL, and a dose of hepatitis B virus vaccine (thimerosal free), lot# 666183/1481Y. The second dose of ROTATEQ was administered on 21-JUL-2010, lot # 668213/0512Z, along with a dose of PENTACEL. It was reported that the baby was recently placed on Nutramigen formula. The condition was not disabling or life threatening. Additional allergy testing would be done in three months. In a note from the pediatric GI, the event was suspected to be either allergic colitis or lymphoid nodules in the colon caused by the ROTATEQ. Pathology report was not yet back from the colonoscopy. Upon internal review, rectal haemorrhage was considered to be other important medical events. The reporter requested lot checks for ROTATEQ. A lot check has been initiated. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Local reaction, Pruritus
Clinical narrative: Local reaction x 3d - erythema, pruritus - progressive. 1) Symptomatic tx. 2) Prophylactic tx (antibiotic). 3) Follow up if symptoms persist > 7d.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Hyperhidrosis, Malaise, Pyrexia
Clinical narrative: Fever, malaise, sweaty, headache lasting 3 days.
Age: 27.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Anxiety, Injection site erythema, Palpitations
Clinical narrative: Anxious, heart racing, 4 cc erythematous area around site of injection (L) deltoid.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site rash, Injection site warmth
Clinical narrative: ~ 2 days after receiving vaccine, a small red rash developed a few inches below injection site (~ 5 in wide). No other symptoms reported other than mild inflammation and warmth at site of rash.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Small red rash at injection site with more redness & slight swelling ~ 3 inches below injection site. Pt reported no other effects other than rash area feeling hot. Told pt to see doctor if rash worsens.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture, CSF culture, Crying, Culture urine, Diet refusal
Clinical narrative: Baby received vaccines approx 11 AM, after getting home became very fussy, inconsolable crying, high pitched crying, refusal to feed, fever 100.8, seen in ER, received LP, bld cx, urine cx, Ceftriaxone given, patient d/c'd home after work up.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Lumbar puncture, Pyrexia
Clinical narrative: Baby received vaccines approx 11 AM, after getting home became very fussy, inconsolable crying, high pitched crying, refusal to feed, fever 100.8, seen in ER, received LP, bld cx, urine cx, Ceftriaxone given, patient d/c'd home after work up.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, pain, warmth, swelling at and near inj site.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema swelling of tricep, bicep - extreme.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema
Clinical narrative: Edema & Erythema below injection site. Edema severe amount.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Urticaria
Clinical narrative: Patient came with some welps on her hand & face, and a picture of her face swollen. She said the symptoms started the evening after taking the FLUVIRIN injection. She was treated at the ER & followed up with PCP - injection administered about 11:30 AM.
Age: 1.53
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site reaction, Rash macular, Vaccination site swelling
Clinical narrative: Imz. 8/31/10, mom called 9/2 to report red, swollen area at vaccine site - dime sized. Several small splotches around site as well.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left thigh swollen with redness.
Age: 13.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Injected limb mobility decreased, Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: On 08/31 playing catch with baseball. Ok at bedtime awoke approximately 0300 09/01 with pain (R) arm. Later in AM decreased ROM and strength of (R) arm for rest of day. 09/02 low grade temp with erythema -> 20cm with local tender (exquisite). 09/03 low grade temp. with 15 cm erythema and minimal tender. Saw MD minimal decreased ROM.
Age: 13.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Tenderness
Clinical narrative: On 08/31 playing catch with baseball. Ok at bedtime awoke approximately 0300 09/01 with pain (R) arm. Later in AM decreased ROM and strength of (R) arm for rest of day. 09/02 low grade temp with erythema -> 20cm with local tender (exquisite). 09/03 low grade temp. with 15 cm erythema and minimal tender. Saw MD minimal decreased ROM.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site atrophy, Injection site rash, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site atrophy in a 5-year-old female subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  Concurrent medical conditions included seasonal allergy.  On 13 July 2010 at 15:00 the subject received 1st dose of HAVRIX (.5 ml, unknown route, left thigh).  On an unspecified date in July 2010, less than one month after vaccination with HAVRIX, the subject experienced injection site skin atrophy, injection site rash and "dimple" (indentation) at injection site.  This case was assessed as medically serious by GSK.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with HAVRIX.  Three weeks prior to a doctor's office visit date of 10 August 2010 the subject's mother called to report a rash and what looked like a dimple on her thigh.  No exact date was given for onset.
Age: 29.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Hypoaesthesia facial, Neuropathy peripheral, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional, via GSK representative, and described the occurrence of cheek numb in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline), BOOSTRIX. On 6 August 2010 at 11:30 the subject received unspecified dose of TWINRIX (unknown, unknown arm), unspecified dose of BOOSTRIX (unknown, unknown arm). On 6 August 2010, 5 minutes after vaccination with BOOSTRIX and TWINRIX, the subject experienced cheek numb and tingling in cheek. At the time of reporting the events were unresolved. The healthcare professional reported that one of the office employees was given a TWINRIX vaccine in one arm and a BOOSTRIX vaccine in the other arm. Within 5 minutes or so, minutes after the administration, the subject developed numbness and tingling in her cheek. The reporter stated that she had to take subject to an urgent care center for medical attention. No further details were provided. Follow-up received from reporting healthcare professional on 31 August 2010: The subject was 29 years-old. The subject was evaluated by a physician at the urgent care facility for "neuropathy (paresthesia and hypoesthesia of left cheek after immunization (side effect))" and was instructed to rest. This case was assessed as medically serious by GSK. The events resolved on an unspecified date. The healthcare professional did not consider that the events may have associated with medical history/concurrent illness, lack of efficacy, erroneous administration or suspected transmission of an infectious agent via a medicinal product.
Sex: F
Vaccine: FLU3
Symptoms: Apgar score abnormal, Bradycardia foetal, Caesarean section, Drug exposure during pregnancy, Incorrect dose administered
Clinical narrative: This prospective pregnancy case was reported by a physician and described the occurrence of drug exposure in utero in a female neonate subject exposed to FLUARIX, (GlaxoSmithKline) and INFLUENZA virus vaccine (manufacturer unspecified; unknown) taken by the pregnant mother.  Concurrent medications included Prenatal vitamins and an epidural.  On an unspecified date, the mother of the subject received an INFLUENZA virus vaccine (manufacturer unspecified; unknown).  On 20 October 2009 at 14:46 the mother of the subject received unspecified dose of FLUARIX (.5 ml, unknown, left arm).  This was considered to be an extra dose of INFLUENZA virus vaccine.  The baby experienced drug exposure in utero.  The mother's date of last menstrual period and estimated date of delivery were not provided.  The subject was exposed to FLUARIX and INFLUENZA virus vaccine during the first trimester.  The outcome of the pregnancy was unknown.  After administering FLUARIX, the physician was informed by the mother of the subject that she had already received a flu vaccine from her primary physician.  The mother of the subject was seven weeks pregnant.  No adverse reactions were noted at the time of reporting.  Follow up information was received on 23 November 2009 via the reporting physician.  The physician reported the mother of the subject's date of last menstrual period was on 01 September 2009 and her estimated date of delivery was 08 June 2010.  The physician reported the conception was normal and did not involve in-vitro fertilization.  No complication was noted with a viable pregnancy at 11 weeks.  At the time of reporting, the physician did not consider the events to be serious.  Follow-up information was received on 24 August 2010 via a Pregnancy Outcome Form.  On, at 40 weeks gestation, the female neonate was delivered via immediate emergent cesarean section due to bradycardia during epidural placement.  It was noted that the fetus was previously healthy.  The neonate was hospitalized.  Weight was 3901 g, length of 46.5 cm and a head circumference of 35 cm.  APGAR scores at 1 minute and 5 minutes were 01 and 04.  No defects were noted.  This baby case, A0813153B is linked to mother case, A0813153A.
Age: 39.0
Sex: F
Vaccine: PNC10
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Oedema peripheral, Skin tightness
Clinical narrative: Significant pain and swelling at site of injection, swelling increased over 24 hour period starting in tricep area, and then consuming entire left arm traveling down elbow and forearm.  Right arm is now twice size as the left arm, hot to the touch, and difficult to move due skin tightening from the swelling.
Age: 39.0
Sex: F
Vaccine: PNC10
Symptoms: Skin warm
Clinical narrative: Significant pain and swelling at site of injection, swelling increased over 24 hour period starting in tricep area, and then consuming entire left arm traveling down elbow and forearm.  Right arm is now twice size as the left arm, hot to the touch, and difficult to move due skin tightening from the swelling.
Age: 57.0
Sex: M
Vaccine: TTOX
Symptoms: Pruritus, Rash
Clinical narrative: Rash on Arms.  Itching.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Diarrhoea, Pain in extremity
Clinical narrative: Severe and uncontrollable diarrhea still continuing after two weeks.  Sore arm and joints.  After fasting for over 5 days, diarrhea resumed when I began eating again.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Diarrhoea, Pain in extremity
Clinical narrative: severe diarrhea, sore arm and joints continuing over two weeks after vaccine
Age: 1.1
Sex: F
Vaccine: PNC13
Symptoms: Crying, Diarrhoea, Irritability, Lethargy, Pyrexia
Clinical narrative: 12:00 Am Tuesday baby awoke from sleep screaming and was difficult to settle.  Tuesday morning 6:30 am fever 102.4 and was fussy and lethargic.  Wednesday morning had fever of 102.3, one liquid stool.  She was again fussy and lethargic.  Thurday fever of 102.3 and extremely irritable and crying, two liquid stools.  Brought her to the doctor, who suspected Roseola.  Friday fever broke.  Saturday pronounced red spots on trunk and neck.
Age: 1.1
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Roseola, Screaming
Clinical narrative: 12:00 Am Tuesday baby awoke from sleep screaming and was difficult to settle.  Tuesday morning 6:30 am fever 102.4 and was fussy and lethargic.  Wednesday morning had fever of 102.3, one liquid stool.  She was again fussy and lethargic.  Thurday fever of 102.3 and extremely irritable and crying, two liquid stools.  Brought her to the doctor, who suspected Roseola.  Friday fever broke.  Saturday pronounced red spots on trunk and neck.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Malaise, Myalgia, Neck pain, Pyrexia
Clinical narrative: Neck pain, malaise, myalgias, fever, redness over site. Illness last two days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site reaction
Clinical narrative: Delayed injection site reaction characterized by redness, inflammation, and itching.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site pruritus, Injection site rash, Nausea, Pruritus
Clinical narrative: Patient states approximately one hour after the the vaccination, rash and itching began at area and began to spread to body.  Felt nauseous.  States fever of 103F.  Had breathing difficulty.  Had Epi-Pen at home for another use and used for this this reaction.  Afterward, used diphenhydramine.  Patient states that after this, felt better and did not seek medical attention.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash
Clinical narrative: Patient states approximately one hour after the the vaccination, rash and itching began at area and began to spread to body.  Felt nauseous.  States fever of 103F.  Had breathing difficulty.  Had Epi-Pen at home for another use and used for this this reaction.  Afterward, used diphenhydramine.  Patient states that after this, felt better and did not seek medical attention.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient presented with swelling, redness, and pain under injection site of Pneumovax.
Age: 3.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: Hard lump, hot to touch with red dots near/around around injection site.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Rash
Clinical narrative: Area was red, itchy and inflammed around injection site by the next morning afer receiving the vaccine. Three days later the red area was spreading getting larger.  By the fourth day the size started to diminish.  By 7 days later the rash had diminished and was much better.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dyspnoea, Malaise
Clinical narrative: Patient called and left a voicemail message that she wasn't feeling well and wanted someone to call her back. I called her at 3:05 PM and asked her to describe what was wrong. She stated that she "wasn't feeling well, having trouble breathing, and my blood pressure is 210." She wanted to know if this was a normal reaction. I told her that it was not, a normal reaction was injection site soreness, cough, fever and or aches. She told me that she called the paramedics and they are on the way. I asked her to get the VIS we gave her, and she hung up on me.
Age: 78.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: 1. Follow up call to patient on 8/26/10. Was told by patient's wife that she thought patient had signs of shingles on his forehead. Refer the patient to his primary care doctor.  2. Patient saw Dr. on 8/27 who suspected shingles and prescribe him Zovirax 400mg. 3. Talked to wife on 9/4/10 and was told patient had seen doctor and was on Zovirax and seems to be doing better. The shingles lesions/rash was only on his forehead and scalp.
Age: 1.51
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abdominal X-ray, Bladder catheterisation, Blood test normal, Chest X-ray normal, Crying
Clinical narrative: Fever until 9/4/2010, ED visit on 9/5/2010 inconsolable crying and writhing in pain. Tests came back normal except for small amt of redness in her ear. I notified the physicians office but they did not think this was a reaction.
Age: 1.51
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pain, Pyrexia, Tympanic membrane hyperaemia, Urine analysis normal, X-ray normal
Clinical narrative: Fever until 9/4/2010, ED visit on 9/5/2010 inconsolable crying and writhing in pain. Tests came back normal except for small amt of redness in her ear. I notified the physicians office but they did not think this was a reaction.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Chills, Cough, Dry throat
Clinical narrative: Aching at injection site, then throat began swelling and was dry, tightness in the chest, slight dry cough, fever and chills, vomited once, weakness, achy - went to bed and did not seek treatment.  The next day I awoke with a headache but, was better.  I did require more sleep that mid-morning.  The following day (on 9/4/10) felt fine.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Pain, Pharyngeal oedema, Pyrexia
Clinical narrative: Aching at injection site, then throat began swelling and was dry, tightness in the chest, slight dry cough, fever and chills, vomited once, weakness, achy - went to bed and did not seek treatment.  The next day I awoke with a headache but, was better.  I did require more sleep that mid-morning.  The following day (on 9/4/10) felt fine.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Aching at injection site, then throat began swelling and was dry, tightness in the chest, slight dry cough, fever and chills, vomited once, weakness, achy - went to bed and did not seek treatment.  The next day I awoke with a headache but, was better.  I did require more sleep that mid-morning.  The following day (on 9/4/10) felt fine.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Immediate post-injection reaction, Pallor, Pharyngeal oedema, Syncope
Clinical narrative: Today, I gave flu shot FLUVIRIN 2010-2011, NDC 66521-113-10, lot#111785P1, exp 03-31-2011 (it was opened-been used). Patient 53 yoa, she has flu shot every year. On the consent and release-injectable vaccinations, question#1: 8 years for tetanus shot, question #2: NA and question #3: NA; question#4-#9: No. I gave flu shot at 1:35PM on left arm, IM; she had reaction: fainting, extreme paleness, swelling of the throat, wheezing, short of breath, difficult breathing. Pharmacist asked her husband to call 9-11 at first but pharmacist came back to pharmacy to call 9-11 and paged manager store to come for help. Manager talked to 9-11 agent. Pharmacist and husband let the patient lay down on the floor; check ABC's- patient was breathing. She had pulse-ok'd--No CPR. Injected epinephrine 1 dose 0.3 mg only, on left thigh, NDC 49502-0500-02 lot#0GM199, exp 09-2011. Wait for paramedics arrive.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Today, I gave flu shot FLUVIRIN 2010-2011, NDC 66521-113-10, lot#111785P1, exp 03-31-2011 (it was opened-been used). Patient 53 yoa, she has flu shot every year. On the consent and release-injectable vaccinations, question#1: 8 years for tetanus shot, question #2: NA and question #3: NA; question#4-#9: No. I gave flu shot at 1:35PM on left arm, IM; she had reaction: fainting, extreme paleness, swelling of the throat, wheezing, short of breath, difficult breathing. Pharmacist asked her husband to call 9-11 at first but pharmacist came back to pharmacy to call 9-11 and paged manager store to come for help. Manager talked to 9-11 agent. Pharmacist and husband let the patient lay down on the floor; check ABC's- patient was breathing. She had pulse-ok'd--No CPR. Injected epinephrine 1 dose 0.3 mg only, on left thigh, NDC 49502-0500-02 lot#0GM199, exp 09-2011. Wait for paramedics arrive.
Age: 3.0
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: I changed my son into pajamas and at that time noticed his upper arm had swollen and turned red around the injection site. There is approximately a 4 inch by 3 inch round area very swollen, red, raised, and firm. No white discoloration is showing in his arm (it doesn't look like a hive). The swelling is obviously related to the injection as the injection puncture site is in the exact middle of the swollen, red, area. His upper left arm is disproportionately larger than the other arm. I gave patient 5mL Hydroxyzine syrup at approximately 1:45 AM in case it was an allergic reaction. It is approximately 50 minutes later and there is no sign of improvement.
Age: 10.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Headache, Injection site induration
Clinical narrative: Dizziness, Everything went black, all color went from lips, unconsciousness. Returned to public health office where she was given the vaccine she was placed on a medical table and told to lay down with an ice pack behind her neck for about 20 minutes. I am filling out this report on Sunday 09/05/10 and her arm is still very hard and sore in the injection spot also, has had diarrhea, upset stomach and headaches.
Age: 10.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Loss of consciousness
Clinical narrative: Dizziness, Everything went black, all color went from lips, unconsciousness. Returned to public health office where she was given the vaccine she was placed on a medical table and told to lay down with an ice pack behind her neck for about 20 minutes. I am filling out this report on Sunday 09/05/10 and her arm is still very hard and sore in the injection spot also, has had diarrhea, upset stomach and headaches.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Injection site erythema, Injection site pain, Pain, Rash
Clinical narrative: Arm where vaccine given was very sore; as I write this 2 days later, it is still extremely tender and painful and moving my arm hurts; skin is red. On the evening the vaccine was administered, I developed a severe rash and burning sensation on my ankles and tops of feet that lasted for about 4 hours. No treatment.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Feeling cold, Hypoaesthesia, Injection site erythema, Malaise, Pain in extremity
Clinical narrative: Severe soreness in arm, fever in arm & whole body at 5 pm.  Took two ibuprofen - 200 mg about 6 pm.  Fever subsided by 7 pm, but soreness in arm becomes more severe and swelling is noted at vaccination site.  Arm so sore that I was unable to position on left side.  On 9/4/2010 I awoke at 5:30 am and prepared to lead a hike on the a trail.  Took two 200 mg Ibuprofen at 6 am.  Left arm is still very sore and swollen.  Began hike at 9:30 am - not feeling very chipper.  Hiked until 12:00 noon, then the group took a lunch break.  Ambient temperature was 60 degrees and quite windy at 12 noon - I became really cold - my hands became numb.  Resumed hiking at 12:30 pm and I warmed up.  Completed hike about 3:45 pm and arrived home at 5 pm.  Had sandwich, took two 200 mg Ibuprofen, which greatly relieved the soreness in the arm, but arm is still quite swollen from the elbow to shoulder.  I was able to sleep on the left side during the night of 9/4/2010.  On morning of 9/5/2010 the arm is still sore and swollen, but the soreness is subsiding.  Redness is noted on the left bicep and swelling is still apparent.  Overall feeling is much better than yesterday.  I think that I'm on the mend.  BTW, I took two 200 mg Ibuprofen this about 9am on 9/5/2010.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: Severe soreness in arm, fever in arm & whole body at 5 pm.  Took two ibuprofen - 200 mg about 6 pm.  Fever subsided by 7 pm, but soreness in arm becomes more severe and swelling is noted at vaccination site.  Arm so sore that I was unable to position on left side.  On 9/4/2010 I awoke at 5:30 am and prepared to lead a hike on the a trail.  Took two 200 mg Ibuprofen at 6 am.  Left arm is still very sore and swollen.  Began hike at 9:30 am - not feeling very chipper.  Hiked until 12:00 noon, then the group took a lunch break.  Ambient temperature was 60 degrees and quite windy at 12 noon - I became really cold - my hands became numb.  Resumed hiking at 12:30 pm and I warmed up.  Completed hike about 3:45 pm and arrived home at 5 pm.  Had sandwich, took two 200 mg Ibuprofen, which greatly relieved the soreness in the arm, but arm is still quite swollen from the elbow to shoulder.  I was able to sleep on the left side during the night of 9/4/2010.  On morning of 9/5/2010 the arm is still sore and swollen, but the soreness is subsiding.  Redness is noted on the left bicep and swelling is still apparent.  Overall feeling is much better than yesterday.  I think that I'm on the mend.  BTW, I took two 200 mg Ibuprofen this about 9am on 9/5/2010.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: injection site red, swollen, warm to touch
Age: 40.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Foetal growth restriction
Clinical narrative: Miscarriage/unborn child not growing, no heartbeat of child.
Age: 3.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site haematoma, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Woke up with arm so swollen it was twice the size of his left one. Red with bruising in middle, hard bump, and skin was warm to the touch. On 9/5/10 arm still swollen, red, warm, and bruised, not skin is peeling a little.
Age: 3.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site warmth, Skin exfoliation
Clinical narrative: Woke up with arm so swollen it was twice the size of his left one. Red with bruising in middle, hard bump, and skin was warm to the touch. On 9/5/10 arm still swollen, red, warm, and bruised, not skin is peeling a little.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Dizziness
Clinical narrative: pt complaining of equilibrium problems and dizziness
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arm where the Pneumococcal Conjugate vaccine was injected swelled from shoulder to elbow to 1.5x its normal size. The area was visibly red and very hot with a line mapping out the entire area on the bottom side of the arm.
Age: 1.92
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever 101 for two days (checked at physician's office -- UTI and ear infection ruled out) no known cause for fever. Followed by rash onset 09/05/2010.
Age: 30.0
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Dizziness, Pain, Pyrexia
Clinical narrative: Dizziness followed by aches and fever.
Age: 34.0
Sex: M
Vaccine: HEPAB
Symptoms: Insomnia, Pain
Clinical narrative: Aches, pains, unable to sleep
Age: 1.02
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMR, PNC13
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site rash
Clinical narrative: LIKELY VACCINE REACTION TO MMR.  PETECHIA AROUND INJECTION SITE, REDNESS, RASH TO L ARM.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Nausea, Rash, Vomiting
Clinical narrative: 1 plus hour after vaccination, nausea and overheated. Emesis after supper meal. Rash around mid-night & presented to ER for treatment at 1 AM on 09/05/2010.. today 09/06/2010 reports no problems.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Immediate post-injection reaction, Thirst
Clinical narrative: Patient said she was feeling hot, thirsty and dizzy. I asked her to remain seated and provided a cup of water. I told her to put her head between her knees. She was still dizzy and I asked if she wanted to lie down. She laid flat on her back and I propped her feet up. She requested more water, and I complied. After about 5 minutes, she said she felt well enough to sit up. She asked for more water, and I asked if she would prefer a pop (cold). She said yes. She drank the pop while sitting, and remained resting for another 15 minutes. She filled out our incident report, said she felt fine and went home. I spoke with her 2 and 1/2 hours later, and she was fine.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test normal, Chest X-ray normal, Dizziness, Dyspnoea, Headache
Clinical narrative: Received shot at approximately 12:30 pm at the local flu shot clinic. Began feeling aches and headache within 20 minutes. Knew this was a possible side effect. By 5:00 p.m. aches were increasingly worse so I took some Tylenol and went to bed. By 1:00 am I was having a hard time breathing, dizzy and aches were so severe my husband called an ambulance and I was treated in the ER with the resulting diagnosis as "reaction to flu shot". I was given oxygen, Benadryl and morphine for the pain. I was released from the hospital at approximately 9 a.m. on 9/5/10. Have been regularly taking Percocet every 4 hours since being released with some relief finally about 1:30 p.m. 9/6/10. Will follow up with Dr. on 9/7/10. I have had flu shots every year that I can remember and have never had a reaction before.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Urine analysis normal, Vaccination complication
Clinical narrative: Received shot at approximately 12:30 pm at the local flu shot clinic. Began feeling aches and headache within 20 minutes. Knew this was a possible side effect. By 5:00 p.m. aches were increasingly worse so I took some Tylenol and went to bed. By 1:00 am I was having a hard time breathing, dizzy and aches were so severe my husband called an ambulance and I was treated in the ER with the resulting diagnosis as "reaction to flu shot". I was given oxygen, Benadryl and morphine for the pain. I was released from the hospital at approximately 9 a.m. on 9/5/10. Have been regularly taking Percocet every 4 hours since being released with some relief finally about 1:30 p.m. 9/6/10. Will follow up with Dr. on 9/7/10. I have had flu shots every year that I can remember and have never had a reaction before.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Muscle tightness, Nausea, Vomiting
Clinical narrative: nausea, vomiting, headache, fatigue, jaw & neck tightness
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Swelling of the lateral side of the R femur around injection site and fever up to 105.0F.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Movement disorder, Musculoskeletal pain, Pain
Clinical narrative: Fluzone HD shot.  Extreme pain in left shoulder (where shot was given).  Unable to move arm for 2 days.  Still painful to raise arm from shoulder.  Took Tylenol for the pain.  Moving arm at all was excruciating all night after injection.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse event, Convulsion, Gaze palsy, Immediate post-injection reaction, Malaise
Clinical narrative: The patient came in to receive a flu shot to Pharmacy. The initial flu shot did not take well into the patient's deltoid causing the vaccine to squirt back out. A new vaccine was prepared for readministration. The patient fainted immediately after receiving the vaccination. Her eyes rolled back and pupils became dilated. 911 was immediately called. Her head was supported and she began to seize slightly. Epipen was immediately administered after and the patient quickly woke up again. The patient felt sick and vomited. The patient was instructed to lie supine on the floor and was closely monitored for 10 minutes until paramedics arrived. The paramedics checked the patient's vital signs and offered to take her to the hospital.  The patient declined a visit to the hospital and was cleared by the paramedics.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Mydriasis, Syncope, Vaccination complication, Vomiting
Clinical narrative: The patient came in to receive a flu shot to Pharmacy. The initial flu shot did not take well into the patient's deltoid causing the vaccine to squirt back out. A new vaccine was prepared for readministration. The patient fainted immediately after receiving the vaccination. Her eyes rolled back and pupils became dilated. 911 was immediately called. Her head was supported and she began to seize slightly. Epipen was immediately administered after and the patient quickly woke up again. The patient felt sick and vomited. The patient was instructed to lie supine on the floor and was closely monitored for 10 minutes until paramedics arrived. The paramedics checked the patient's vital signs and offered to take her to the hospital.  The patient declined a visit to the hospital and was cleared by the paramedics.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Nodule, Pyrexia, Secretion discharge
Clinical narrative: Started the day after shot, started as a knot & fever (101 degrees), took TYLENOL & BENADRYL. Developed 2 large blisters & redness. Blisters are weeping. Went to urgent care & received an Rx for KEFLEX.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Eye swelling, Eyelid oedema
Clinical narrative: Approximately 2 hrs after inject pt noticed swelling around eyes & asthma symptoms. Pt's eyes were swollen shut the following morning. Swelling & asthma resolved by noon on 9/3/2010.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site reaction, Pyrexia
Clinical narrative: 2 hours fever, chills, & injection site reaction. Pt did not use anything to relieve symptom.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: 2 hour fever, chills, & injection site reaction (soreness, redness, and swelling).
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Pain down arm 8 hours post injection. General malaise, fever, chills. Pain down influenza arm.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Malaise, Pain in extremity, Paraesthesia
Clinical narrative: Pain down arm 1 hour post injection. Malaise, fatigue, chills 8 hours post injection. Follow up next day Ok but still tingling. Take flu shot annually. This has never happened.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: FLUVIRIN given Sunday 8/29/10 at 5:50 PM. Patient presented at pharmacy 9/3/10 at 2:00 PM with large injection site reaction. Patient claims that site has worsened since 8/29. No other complaints - just injection site reaction. Raised circle (~ dime size). Patient taking BENADRYL and ibuprofen. Will contact Doctor if condition worsens.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysphagia, Epistaxis, Hypoaesthesia facial, Injection site erythema
Clinical narrative: Lightedness, vertigo, numbness left side of face, bilateral nose bleeds, trouble swallowing, injection site redness all developed within about 1 day and lasted for 2-3 days.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Lightedness, vertigo, numbness left side of face, bilateral nose bleeds, trouble swallowing, injection site redness all developed within about 1 day and lasted for 2-3 days.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Flushing, Headache
Clinical narrative: 5 min after shot pt had symptoms of flushing, dizziness, headache, tired.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Erythema, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Vaccine given in left arm. Patient came in with (L) arm swollen, red, and warm to touch. Arm was sore and difficult to raise or touch. Redness radiated to chest some. Had some trouble breathing. Did an updraft treatment at home and given diphenhydramine 50 mg.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Vaccine given in left arm. Patient came in with (L) arm swollen, red, and warm to touch. Arm was sore and difficult to raise or touch. Redness radiated to chest some. Had some trouble breathing. Did an updraft treatment at home and given diphenhydramine 50 mg.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Immediate post-injection reaction, Swelling
Clinical narrative: Skin turned blue right after administration and area bumped.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash macular, Vaccination site reaction
Clinical narrative: Pt had dime size red blotches around vaccine site and down arm.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Rash, Swelling
Clinical narrative: Rash, swelling, soreness. Patient consulted family physician who prescribed CLARITIN, PEPCID AC and ALEVE. Patient rash and other sx started resolving by 9/3 fully resolved by 9/5.
Age: 47.0
Sex: M
Vaccine: MEN, SMALL, YF
Symptoms: Anxiety, Arthralgia, Depression, Headache, Hypersensitivity
Clinical narrative: Thyroid problem - on treatment. Allergies - on treatment. Headache. Depression, Anxiety - on treatment. Painful joints -OT. Vertigo - OT.
Age: 47.0
Sex: M
Vaccine: MEN, SMALL, YF
Symptoms: Thyroid disorder, Vertigo
Clinical narrative: Thyroid problem - on treatment. Allergies - on treatment. Headache. Depression, Anxiety - on treatment. Painful joints -OT. Vertigo - OT.
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Breech presentation, Caesarean section, Congenital anomaly, Drug exposure during pregnancy, Ear tube insertion
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A female patient on an unspecified date was vaccinated with a third dose of GARDASIL (lot #, site and route of administration not reported). At the time that the patient was vaccinated, she did not know that she was 2 weeks pregnant. On an unspecified date ultrasound before birth revealed no legs. Laboratory tests performed found no genetic defect. The mother was instructed to register on this web site. On an unspecified date she had a male baby (weight 6 pounds 10 ounces) who was born without legs. Onset date reported as age 0.3 (28-JUN-2008). During the pregnancy, the mother did not receive any other medication or vaccines. The listing indicated that the event was considered to be disabling and a congenital anomaly. The original reporting source was not provided. The VAERS ID # is 348547. Follow up information has been received from a medical assistant concerning a baby male patient, whose mother on 29-JUN-2007 was vaccinated with the first dose of GARDASIL (Lot # 657736/0389U) (route not reported), on 03-MAR-2008 was vaccinated with the second dose of GARDASIL (Lot # 659441/1446U) (route not reported) and on 20-JUN-2008, when she was 2 weeks pregnant was vaccinated with the third dose of GARDASIL (Lot # 659962/1740U) (route not reported). Concomitant therapy given on 20-JUN-2008 included a dose of HAVRIX (Lot # AHAVB264CA) (route not reported). Medical assistant reported that on 23-FEB-2009 the patient was born by a C-section due to a breech birth. The baby was born with no lower extremities. On an unspecified date, the baby had tubes placed in his ears. The baby was seen by an orthopedic specialist for prosthesis of lower extremities. The patient sought medical attention by seeing an orthopedic specialist. Upon internal review, breech birth was considered to be an other important medical event. The baby born with not lower extremities was disabling and a congenital anomaly. The mother's experience has been captured in WAES 0907USA05158. Additional information has been requested. The information describe above has been previously submitted in WAES 0907USA05185.
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Limb reduction defect
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A female patient on an unspecified date was vaccinated with a third dose of GARDASIL (lot #, site and route of administration not reported). At the time that the patient was vaccinated, she did not know that she was 2 weeks pregnant. On an unspecified date ultrasound before birth revealed no legs. Laboratory tests performed found no genetic defect. The mother was instructed to register on this web site. On an unspecified date she had a male baby (weight 6 pounds 10 ounces) who was born without legs. Onset date reported as age 0.3 (28-JUN-2008). During the pregnancy, the mother did not receive any other medication or vaccines. The listing indicated that the event was considered to be disabling and a congenital anomaly. The original reporting source was not provided. The VAERS ID # is 348547. Follow up information has been received from a medical assistant concerning a baby male patient, whose mother on 29-JUN-2007 was vaccinated with the first dose of GARDASIL (Lot # 657736/0389U) (route not reported), on 03-MAR-2008 was vaccinated with the second dose of GARDASIL (Lot # 659441/1446U) (route not reported) and on 20-JUN-2008, when she was 2 weeks pregnant was vaccinated with the third dose of GARDASIL (Lot # 659962/1740U) (route not reported). Concomitant therapy given on 20-JUN-2008 included a dose of HAVRIX (Lot # AHAVB264CA) (route not reported). Medical assistant reported that on 23-FEB-2009 the patient was born by a C-section due to a breech birth. The baby was born with no lower extremities. On an unspecified date, the baby had tubes placed in his ears. The baby was seen by an orthopedic specialist for prosthesis of lower extremities. The patient sought medical attention by seeing an orthopedic specialist. Upon internal review, breech birth was considered to be an other important medical event. The baby born with not lower extremities was disabling and a congenital anomaly. The mother's experience has been captured in WAES 0907USA05158. Additional information has been requested. The information describe above has been previously submitted in WAES 0907USA05185.
Age: 18.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Incorrect dose administered
Clinical narrative: Patient received an adult dose of Hep B instead of the pediatric dose for Hep B according to age. Notified patient and patient did not have an reaction complaints to Hep B dose.
Age: 18.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received an adult dose of Hep B instead of the pediatric dose for Hep B according to age. Notified patient and patient did not have an reaction complaints to Hep B dose.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Induration, Rash erythematous
Clinical narrative: Nine erythema spots approximately 1 inch diameter that are raised and feel hard, spread throughout upper torso. Surfaced approximately 1 day after vaccine.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous, Skin burning sensation, Skin warm
Clinical narrative: On 8/31/10 pt. noticed 3 spots on her left arm that were red and warm to touch and stated it feels like it "burns" "under the skin a little bit".
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Convulsion, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Patient received ADACEL and MENACTRA in our office. He was calm while getting vaccines. At the check out counter he passed out and Mom described "stiffened seizure activity". He recovered in our office and returned home.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, PNC13, VARCEL
Symptoms: Abdominal pain upper, Blister, Blood culture negative, C-reactive protein normal, Culture wound
Clinical narrative: C/O redness to (L) thigh, two days after vaccines thigh became swollen and did not feel well. C/O tummy ache and nausea, malaise and decreased appetite. Blister.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Full blood count normal, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: C/O redness to (L) thigh, two days after vaccines thigh became swollen and did not feel well. C/O tummy ache and nausea, malaise and decreased appetite. Blister.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, PNC13, VARCEL
Symptoms: Nausea, X-ray limb normal
Clinical narrative: C/O redness to (L) thigh, two days after vaccines thigh became swollen and did not feel well. C/O tummy ache and nausea, malaise and decreased appetite. Blister.
Age: 42.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP, YF
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.95
Sex: F
Vaccine: DTAP, HEP, HEPA
Symptoms: Erythema, Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Pt. given DTAP on 8/3/10 to (L) thigh. Pts mom noticed the same evening, leg was red, swollen. She called advise line they instructed mom to apply ice & giveTYLENOL for fever/pain. Mom called office 8/5/10 stating (L) leg more swollen/hard/hot to touch & with vesicular rash.
Age: 1.95
Sex: F
Vaccine: DTAP, HEP, HEPA
Symptoms: Oedema peripheral, Pain, Pyrexia, Rash vesicular
Clinical narrative: Pt. given DTAP on 8/3/10 to (L) thigh. Pts mom noticed the same evening, leg was red, swollen. She called advise line they instructed mom to apply ice & giveTYLENOL for fever/pain. Mom called office 8/5/10 stating (L) leg more swollen/hard/hot to touch & with vesicular rash.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Cough, Malaise, Pain, Pyrexia
Clinical narrative: Patient had the flu shot on 8-16. She felt sick on 8-19. Her symptoms include low grade fever, body ache, cough & congestion. She missed a couple of days of work.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: Patient had the flu shot on 8-16. She felt sick on 8-19. Her symptoms include low grade fever, body ache, cough & congestion. She missed a couple of days of work.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Joint range of motion decreased, Pain, Skin warm
Clinical narrative: Pt had redness, warmth on arm radiating up neck on (R) side. Also had body aches. Unable to raise arm above shoulder. Patient was informed to ice area, take OTC pain med and call if not better. Spoke with pt 8/30/10 and sx were much better, almost gone.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt seen x 3 days ago now presents with red, hot, swelling, (cellulitis) left deltoid. Treated with cephalexin 500mg x 7 day.