chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial case received on 18 December 2009 from a pharmacist. A 32 year old female patient received a left arm injection of FLUZONE (lot number U3224BB) on 17 December 2009. "Later that day" the patient experienced burning at the injection site and a slight red area. The next day the adverse events continued and the patient developed more burning sensation at the site and redness the size of a "nickle" at the site and swollen area. The patient experienced soreness of back area at trapezius area. The patient was advised to take anti-inflammatory and BENADRYL and to return call if adverse events worsened or continue or to seek health care from a health care professional. It was unknown at the time of the report if the patient recovered. Follow-up information was received on 01 February 2010 from a pharmacist. The pharmacist had suggested the use of Ibuprofen to the patient as an anti-inflammatory. He stated he presumed the adverse events resolved, but has had no further contact with the patient, who lives in another part of the state. The patient's physician is unknown. It is unknown if the events resolved. Documents held by sender: none.
Age: 9.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Dizziness, Fall, Immediate post-injection reaction
Clinical narrative: Initial information was received on 30 December 2009 from a health care professional. A 9 year old male patient with a history of asthma got dizzy and fell backwards immediately after receiving FLUZONE (lot number U3232AA) and H1N1 (lot number UP008AA) both administered intramuscularly in the left deltoid "one month a ago". After 15 minutes of observation, the patient was sent home. The patient recovered from the events. Follow-up information received on 25 January 2010 from a healthcare professional. The date the patient received the vaccinations was 12 November 2009. The reporter noted the patient was "fine after 15" minutes on 12 November 2009 and no treatment was given. List of Documents held by Sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Drug exposure during pregnancy, Premature baby
Clinical narrative: Initial report received from a health care professional via MERCK on 31 August 2010. A neonate (sex not provided) received transplacental on 15 September 2010 FLUZONE, lot number not provided. The patient was born at 29 weeks gestation on 10 December 2009 with the mother's expected date of delivery (EDD) of 23 December 2009. The mother delivered preterm with prelabor rupture of membranes. The outcome was not reported. The mother's case was captured in case 2010-04804 and the other twin was captured in case 2010-04806. Documents held by sender: None.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received 26 October 2009 from a health care professional. A six year old female patient who is a part of a cluster of two patients complained of blistering all along the arm, had swelling, and was hot to touch at the left deltoid 48 hours after receiving FLUZONE (lot number UT3252AA) intramuscularly in the left deltoid on the morning of 22 October 2009. The patient had a doctor's visit and was treated with ORAPRED. The patient was not recovered. List of Documents held by Sender: none. The other patient from this cluster has been captured in case number 2009-04493.
Age: 1.43
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Erythema multiforme, Hypersensitivity, Rash erythematous
Clinical narrative: Initial report received on 19 January 2010 from a healthcare professional, who also provided follow-up information on 08 February 2010. From the information received on 08 February 2010, it was determined a case narrative was required; therefore the following narrative has captured all case information received to date. A 17 month old male patient received a left thigh intramuscular injection of FLUZONE (lot number U3265KA) and a right thigh intramuscular injection of H1N1 (lot number UT023FA) on 18 January 2010. The initial report stated the patient experienced a whole body red raised rash on 18 January 2010. When seen in the office on 19 January 2010, the physician diagnosed the rash as "hypersensitivity reaction". On an unspecified date prior to the office visit, the parents administered TYLENOL. The patient was not ill at the time of the vaccinations. There were no pre-existing medical conditions, no allergies and no concomitant medications. Previous vaccinations received by the patient were "FLUZONE Pediatric, no preservative (.25 mL) and H1N1 (.25 mL)" on 09 December 2009. The initial report indicated the patient had not recovered. In the follow-up information it was noted that the mother stated the rash was improving, but the physician told her to monitor the "erythematic multiformi" and call the office with any concerns or "if it doesn't clear up". The follow-up information indicated the patient had experienced erythema multiforme. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Body temperature increased, Cough, Dark circles under eyes, Pallor
Clinical narrative: Initial report was received from a health care professional on 15 September 2010. A four-year-old male patient with no reported past medical history, had received FLUZONE, lot number UT3567AA (route and site of administration not reported) on 13 September at 10:00, and an unspecified amount of time later, experienced a temperature of 103.1, itching all over, and coughing. He was noted to be pale, weak and had dark circles underneath his eyes. The patient was treated with CLARITIN, TYLENOL, and a "bath". His temperature responded to initial treatment but was reported to have increased to 104.3. The child was reported to be "feeling better" 24 hours later, however he was not reported to have recovered. No further information was available at the time of this report. Documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Initial report was received from a health care professional on 15 September 2010. A four-year-old male patient with no reported past medical history, had received FLUZONE, lot number UT3567AA (route and site of administration not reported) on 13 September at 10:00, and an unspecified amount of time later, experienced a temperature of 103.1, itching all over, and coughing. He was noted to be pale, weak and had dark circles underneath his eyes. The patient was treated with CLARITIN, TYLENOL, and a "bath". His temperature responded to initial treatment but was reported to have increased to 104.3. The child was reported to be "feeling better" 24 hours later, however he was not reported to have recovered. No further information was available at the time of this report. Documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Oedema peripheral, Pain in extremity, Skin discolouration
Clinical narrative: After vaccination, pt arm was swollen up & purple. After 3wks of injection, patients arm is still sore & stiff.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Large, red, swollen, hot to touch are on left thigh, with induration. Treatment is BENADRYL and Cephalexin.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: < than 24 hours after injection, redness approximately 3" across at immunization site, no fluctuance as yet.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness, hardness at the site still bothered her for 3 weeks.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Pain in extremity
Clinical narrative: Redness until the elbow hard and painful.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Chest discomfort, Diarrhoea, Erythema, Headache
Clinical narrative: Pt. states he experienced HA sore (R) arm from shoulder to hand, malaise, increased anxiety causing chest tightness & diarrhea. Sx started in afternoon throughout noc. At time of visit today at approx 0930 he was WNL of his usual (R) arm without swelling or redness.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Pain in extremity, Swelling
Clinical narrative: Pt. states he experienced HA sore (R) arm from shoulder to hand, malaise, increased anxiety causing chest tightness & diarrhea. Sx started in afternoon throughout noc. At time of visit today at approx 0930 he was WNL of his usual (R) arm without swelling or redness.
Age: 14.0
Sex: F
Vaccine: FLUN3, HEP, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Started on 11/9/10 around 11:00 AM pt at school and had no ride to return to clinic. Pt presents with large welt size: L 5.5 cm, W 6.3 cm, erythema and swollen right upper lateral arm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Crying, Swelling face, Swollen tongue, Urticaria
Clinical narrative: 2 hives, facial swelling, tongue swelling, crying, coughing.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Rheumatoid arthritis, Rheumatoid factor positive
Clinical narrative: Arthralgias soon after hepatitis B vaccines. Subsequently diagnosed with rheumatoid arthritis.
Age: 1.29
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Ammonia, Aphasia, Arthralgia, Body temperature increased, Cerebellar ataxia
Clinical narrative: Sleeping, diarrhea, nausea, vomiting, 2 febrile seizures, loss of consciousness, headaches, high-pitched screaming, sleep 3 hours, up for 4 screaming joint pain, dizziness, falling wide gait, eye conjunctivitis of yellowish-orange coloration, lucid eye movement, temperatures, lack of appetite, diagnosed with cerebellar ataxia, loss of speech & slurred speech. Head banging & backwards walking, swelling of face, rash for two weeks, and redness of left thigh.
Age: 1.29
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Conjunctival discolouration, Conjunctivitis, Convulsion, Decreased appetite, Diarrhoea
Clinical narrative: Sleeping, diarrhea, nausea, vomiting, 2 febrile seizures, loss of consciousness, headaches, high-pitched screaming, sleep 3 hours, up for 4 screaming joint pain, dizziness, falling wide gait, eye conjunctivitis of yellowish-orange coloration, lucid eye movement, temperatures, lack of appetite, diagnosed with cerebellar ataxia, loss of speech & slurred speech. Head banging & backwards walking, swelling of face, rash for two weeks, and redness of left thigh.
Age: 1.29
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Dizziness, Dysarthria, Eye discharge, Eye movement disorder, Fall
Clinical narrative: Sleeping, diarrhea, nausea, vomiting, 2 febrile seizures, loss of consciousness, headaches, high-pitched screaming, sleep 3 hours, up for 4 screaming joint pain, dizziness, falling wide gait, eye conjunctivitis of yellowish-orange coloration, lucid eye movement, temperatures, lack of appetite, diagnosed with cerebellar ataxia, loss of speech & slurred speech. Head banging & backwards walking, swelling of face, rash for two weeks, and redness of left thigh.
Age: 1.29
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Febrile convulsion, Gait disturbance, Head banging, Headache, Injection site erythema
Clinical narrative: Sleeping, diarrhea, nausea, vomiting, 2 febrile seizures, loss of consciousness, headaches, high-pitched screaming, sleep 3 hours, up for 4 screaming joint pain, dizziness, falling wide gait, eye conjunctivitis of yellowish-orange coloration, lucid eye movement, temperatures, lack of appetite, diagnosed with cerebellar ataxia, loss of speech & slurred speech. Head banging & backwards walking, swelling of face, rash for two weeks, and redness of left thigh.
Age: 1.29
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Laboratory test, Loss of consciousness, Lumbar puncture, Nausea, Nuclear magnetic resonance imaging
Clinical narrative: Sleeping, diarrhea, nausea, vomiting, 2 febrile seizures, loss of consciousness, headaches, high-pitched screaming, sleep 3 hours, up for 4 screaming joint pain, dizziness, falling wide gait, eye conjunctivitis of yellowish-orange coloration, lucid eye movement, temperatures, lack of appetite, diagnosed with cerebellar ataxia, loss of speech & slurred speech. Head banging & backwards walking, swelling of face, rash for two weeks, and redness of left thigh.
Age: 1.29
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Rash, Red blood cell sedimentation rate, Screaming, Sleep disorder, Somnolence
Clinical narrative: Sleeping, diarrhea, nausea, vomiting, 2 febrile seizures, loss of consciousness, headaches, high-pitched screaming, sleep 3 hours, up for 4 screaming joint pain, dizziness, falling wide gait, eye conjunctivitis of yellowish-orange coloration, lucid eye movement, temperatures, lack of appetite, diagnosed with cerebellar ataxia, loss of speech & slurred speech. Head banging & backwards walking, swelling of face, rash for two weeks, and redness of left thigh.
Age: 1.29
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Swelling face, Urine analysis, Vomiting
Clinical narrative: Sleeping, diarrhea, nausea, vomiting, 2 febrile seizures, loss of consciousness, headaches, high-pitched screaming, sleep 3 hours, up for 4 screaming joint pain, dizziness, falling wide gait, eye conjunctivitis of yellowish-orange coloration, lucid eye movement, temperatures, lack of appetite, diagnosed with cerebellar ataxia, loss of speech & slurred speech. Head banging & backwards walking, swelling of face, rash for two weeks, and redness of left thigh.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Motor dysfunction, Muscular weakness
Clinical narrative: 2 days after vaccination; onset of numbness, diminished fine motor control in (L) hand, and weakness. All symptoms in (L) arm & hand. Beginning to resolve as of 11/12/10.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 7 x 8cm red swollen area at injection site.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Pt. had multiple erythematous wheals on trunk, neck, face. Stated he was experiencing severe itching, mom present, stated she had applied BENADRYL cream to areas noted, without much relief. Mom instructed to adm. oral BENADRYL to pt., per pkg. instr. and if no relief to take son to ER.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: 1115 Vaccine administered. 1125 c/o mild nausea and dizziness, local reaction at site of injection (warmth to touch, redness), 1140 redness at site decreasing in size, states nausea & dizziness improving. Dizziness is only when standing, 1215 redness & warm to touch continue to decrease as well as nausea per pt. No longer dizzy.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site anaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Pt got Influenza injection on Thursday 11/11/2010. Called me at 1230 on Friday 11/12/10, complaining that arm was extremely sore and numb from injection site down past elbow. She said this started about 5 AM Friday.
Age: 49.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site irritation, Pain in extremity
Clinical narrative: Patient returned 10-19-10 the day after receiving vaccine, he reported sore arm and no redness or swelling at injection site. Counseled him to watch for swelling/redness at injection site and inform us how he was progressing. Patient called his clinic after injection site irritation got worse. Patient went to Emergency Room 10-21-10. Antibiotics and pain medication prescribed, possible cellulitis diagnosed. 10-28-10 patient contacted and he reported symptom improvement.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV, PNC13
Symptoms: Body temperature increased, Retching, Vomiting
Clinical narrative: 3AM 11/12/2010. Child awoke with temp 101 degrees, vomiting then dry heaving. Vomiting stopped at 8AM and child was sleeping comfortably.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Pt. developed fever/chills, aches 39.7 C with Rx of IV fluids, antipyretics & eventual recovery to normal after 2-3 days at home.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Patient reported on 11/09/2010 that she felt pain during injection (not usual burning sensation) and resulting pain from injection site across shoulder into neck and down arm. 11/10/2010 Patient reported symptoms diminished slightly. Had contacted PBP and was encouraged to treat with ice or heat and call if symptoms worsen.
Age: 1.61
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Dyskinesia, Electroencephalogram, Pyrexia
Clinical narrative: Received Hepatitis A & Flu vaccine on 11/8/10 & that night developed fever & then next day noted jerky movements & becoming more frequent & seen at office 11/11/10 & referred to neurologist.
Age: 80.0
Sex: U
Vaccine: FLU3
Symptoms: Blood disorder, Haemorrhage, Induration, Injection site erythema, Injection site swelling
Clinical narrative: Swelling & redness at site, bleeding & blood under the skin. Area became hard but only spread to a diameter of 1-2 inches. Pt wanted to put ice on site & come later for injection.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient given vaccines on 10/29/10 and 3 days later he developed swelling and redness at the vaccine site on Rt thigh, and since then symptoms had worsened, with the site red and tender. Started on KEFLEX and BACTRIM. Outlined area - advised mom if symptoms spread to have him be seen. F/u next day on 10/30 - improved nicely. No tenderness, inflammation, was resolving nicely.
Age: 65.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Diarrhoea
Clinical narrative: Severe diarrhea
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Slight redness and tenderness at injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Inflammation, Local reaction
Clinical narrative: Large local inflammatory reaction in left arm s/p IPV & VARIVAX in that arm.
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Diarrhoea
Clinical narrative: Severe diarrhea
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood culture, Cellulitis, Dizziness, Erythema, Feeling hot
Clinical narrative: On evening of receiving vaccine, began feeling feverish, achy, lightheaded. The following day noticed intense pain of R arm (vaccine received in R arm) but from elbow to bicep.  Noticed spreading warmth and redness of bicep, tenderness of antecubital fossa.  Seen in clinic 11/12, area of R bicep appears cellulitic, patient tachycardic, wbc 11K, US negative for RUE DVT.  Given 7 day course of Bactrim.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Pain, Skin warm, Tachycardia, Tenderness
Clinical narrative: On evening of receiving vaccine, began feeling feverish, achy, lightheaded. The following day noticed intense pain of R arm (vaccine received in R arm) but from elbow to bicep.  Noticed spreading warmth and redness of bicep, tenderness of antecubital fossa.  Seen in clinic 11/12, area of R bicep appears cellulitic, patient tachycardic, wbc 11K, US negative for RUE DVT.  Given 7 day course of Bactrim.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Ultrasound scan normal, White blood cell count increased
Clinical narrative: On evening of receiving vaccine, began feeling feverish, achy, lightheaded. The following day noticed intense pain of R arm (vaccine received in R arm) but from elbow to bicep.  Noticed spreading warmth and redness of bicep, tenderness of antecubital fossa.  Seen in clinic 11/12, area of R bicep appears cellulitic, patient tachycardic, wbc 11K, US negative for RUE DVT.  Given 7 day course of Bactrim.
Age: 61.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Dysphagia
Clinical narrative: Difficult swallowing Still have this now.
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Sensory loss, VIIth nerve paralysis
Clinical narrative: She describes what definitely looks to be a Right sided Bell's Palsy, very mild, already improving today 11/12/2010. Physical exam consistent with this also with very mild decreased sensation on right cheek only. No actual droop, no lid changes, rest of cranial nerve exam normal. Parents report she got the influenza vaccine injection (NOT nasal spray), but I don't remember where so not sure who to tell about it except VAERS. Also, had URI/LRI diagnosed 8 wks ago.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Eye pruritus, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: chills, cough, wheezing, congestion, sore throat, itchy eyes
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: chills, cough, wheezing, congestion, sore throat, itchy eyes
Age: 13.0
Sex: F
Vaccine: HPV2
Symptoms: Fall, Grand mal convulsion
Clinical narrative: Patient was receiving vaccinations at a school based clinic.  After she received her HPV vaccination she went to stand in line to get her Hepatitis A vaccination.  While standing in line she was noted to have tonic/clonic seizure activity, fluttering of her eyes, and she fell to the floor on her left side.  She was attended to immediately and was awakened within seconds.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient returned today with grandparents stating that she is having a reaction to the flu vaccine. The right arm Deltoid area was red, warm to touch, and tender to touch area was 5 &1/2 cm x 6 cm in size.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Soreness and pain from the site of the injection all the way to the wrist. Symptoms last for more than 1 week now and only subside when taking acetaminophen.  Patient was instructed to contact Primary Care Physician for follow-up.
Age: 15.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: 2 large red rash areas appeared in deltoid area of left arm. Warm and painful to touch.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Injection site haematoma, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Large bruise to upper left deltoid area with 2 large red, rashed rash areas immediately below. Area warm to touch and very painful. Pain tends to radiate down the arm. Also reports coughing up thick hard mucus.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Productive cough
Clinical narrative: Large bruise to upper left deltoid area with 2 large red, rashed rash areas immediately below. Area warm to touch and very painful. Pain tends to radiate down the arm. Also reports coughing up thick hard mucus.
Age: 38.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Headache, Listless, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: Widespread, intensively severe muscle pain (esp. lower back, shoulders, neck). Large muscle weakness. Headache. Fever ranging from 101.2 F - 102.1 F. Listlessness.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pain, Rash erythematous
Clinical narrative: FINE RED RASH AT BOTH WRISTS, NECK- FEELS LIKE LITTLE STINGS"  REDDENED AREA BELOW SITE OF INJECTION ON LEFT DELTOID
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: I was injured at work on 11/8 (gouge wound to my arm) & was sent to medical center for a tetanus shot. At medical center I received a Tdap injection (no simple tetanus vaccine was available). Within 1 hour of vaccine administration, I felt feverish, achy, & fatigued. I took some aspirin & fell asleep by 6 PM. When I woke up at 2:15 AM, the injection site was red, swollen, & painful. Today (11/12) the injection site is still swollen & red. While running errands today, I developed a fever of over 101 degrees & had to go to bed. I reported this to my employer's nurse referral service; she said that I should take Advil or aspirin, apply a cold pack, take antihistamine, & rest. She also asked me to call medical center to report the reaction. I spoke to a supervisor there who consulted with an MD who wanted me to come back to medical center & see an MD. I did not feel well enough to do that. I have taken aspirin, used an ice pack on the injection site, & will be taking Benadryl. My temperature has currently dropped to 99.9.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: I was injured at work on 11/8 (gouge wound to my arm) & was sent to medical center for a tetanus shot. At medical center I received a Tdap injection (no simple tetanus vaccine was available). Within 1 hour of vaccine administration, I felt feverish, achy, & fatigued. I took some aspirin & fell asleep by 6 PM. When I woke up at 2:15 AM, the injection site was red, swollen, & painful. Today (11/12) the injection site is still swollen & red. While running errands today, I developed a fever of over 101 degrees & had to go to bed. I reported this to my employer's nurse referral service; she said that I should take Advil or aspirin, apply a cold pack, take antihistamine, & rest. She also asked me to call medical center to report the reaction. I spoke to a supervisor there who consulted with an MD who wanted me to come back to medical center & see an MD. I did not feel well enough to do that. I have taken aspirin, used an ice pack on the injection site, & will be taking Benadryl. My temperature has currently dropped to 99.9.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site pain, Insomnia, Myalgia
Clinical narrative: Chills, pain at injection site, fever 4 degrees above normal, intense headache, jaw ache, muscle ache, especially in arms and legs. Only relief for arms and legs was extending, shaking and kicking - muscle phase lasted 4 hours. Couldn't sleep until next day.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in jaw, Pyrexia
Clinical narrative: Chills, pain at injection site, fever 4 degrees above normal, intense headache, jaw ache, muscle ache, especially in arms and legs. Only relief for arms and legs was extending, shaking and kicking - muscle phase lasted 4 hours. Couldn't sleep until next day.
Age: 69.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cough, Dizziness, Dysphonia, Headache, Heart rate increased
Clinical narrative: First of all my eye got bloodshot.  Then I started with a headache, that I still have.  The next was coughing.  When I awoke on 11/10/2010 I was very dizzy and my heart was beating fast and very irregular.  I was hoarse. My eyes were more red and my sinuses were swollen.  Most of the symptoms have gone away except the headache and dizziness.
Age: 69.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Heart rate irregular, Ocular hyperaemia, Swelling
Clinical narrative: First of all my eye got bloodshot.  Then I started with a headache, that I still have.  The next was coughing.  When I awoke on 11/10/2010 I was very dizzy and my heart was beating fast and very irregular.  I was hoarse. My eyes were more red and my sinuses were swollen.  Most of the symptoms have gone away except the headache and dizziness.
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Pain, Vomiting
Clinical narrative: stomach pain, throwing up, general body aches
Age: 0.77
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Started with localized urticaria on right thigh
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Headache, Pyrexia, Vomiting
Clinical narrative: Fever, headache, dizziness, and vomiting. I contacted doctor to request medication, and was given Ondanestron ODT 4mg tablets for nausea and was told to make sure my daughter drank plenty of fluids.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash of raised red bumps starting as a small crescent on lower front right ribs.  Stretched around the ribs along relatively straight path just above waistline to end just about an inch onto the back. Diagnosed by doctor as shingles. Patient never had chickenpox or had been exposed to anyone with chickenpox but had varicella vaccine on 1/25/10.
Age: 57.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abdominal pain, Cough, Diarrhoea, Feeling abnormal, Influenza
Clinical narrative: Odd feeling, while attending an event in downtown -- throat tightening at first. As the evening progressed, it felt as if I were having a flu onset. After a brief dinner with friends, I went to bed & kept waking up with a VERY sore torso, ongoing tighness of throat/coughing. It took me awhile to finally take out the "possible side effects" brochure and know that it might be the flu shot. As the day wore on, I also had diarrhea, and when I reached home (a 3-hour drive) I slept for an hour and then felt much better. As the 24 hours progressed, I felt better every hour. I only got the shot because my husband had gotten the flu the previous year, and we travel in the state alot, and his physician recommended it for both of us. I had some time in the afternooon, but was attending a business function that evening. If I had known what type of reaction I would experience, I would not have gotten the shot. The warnings were written, but not clearly expressed, in my opinion.
Age: 57.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Throat tightness
Clinical narrative: Odd feeling, while attending an event in downtown -- throat tightening at first. As the evening progressed, it felt as if I were having a flu onset. After a brief dinner with friends, I went to bed & kept waking up with a VERY sore torso, ongoing tighness of throat/coughing. It took me awhile to finally take out the "possible side effects" brochure and know that it might be the flu shot. As the day wore on, I also had diarrhea, and when I reached home (a 3-hour drive) I slept for an hour and then felt much better. As the 24 hours progressed, I felt better every hour. I only got the shot because my husband had gotten the flu the previous year, and we travel in the state alot, and his physician recommended it for both of us. I had some time in the afternooon, but was attending a business function that evening. If I had known what type of reaction I would experience, I would not have gotten the shot. The warnings were written, but not clearly expressed, in my opinion.
Age: 0.58
Sex: M
Vaccine: DTAP, PPV
Symptoms: Irritability, Pain in extremity, Pyrexia, Rash, Swelling
Clinical narrative: Swollen left leg and left foot, redness, bright red rash on left cheek, low grade fever, fussiness, pain in left leg/foot, refusal to use left leg.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pallor, Rash erythematous, Rash generalised, Rash macular
Clinical narrative: Rash all over body x 2 days (10 days post MMR) erythematous - blanching of skin coalescent at places, no itchiness, macular, no papules or vesicles.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Rash erythematous
Clinical narrative: Has red rash on trunk & arm opposite of vaccination site. No hives. No difficulty breathing. Recommended BENADRYL.
Age: 38.0
Sex: M
Vaccine: MMR
Symptoms: Headache
Clinical narrative: Pt received MMR 8/19/10 -> reports severe headache (10/10) on 8/31/10. Sent to ER.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose normal, Dizziness, Dyskinesia, Hypertension, Hypoaesthesia
Clinical narrative: Symptom: Nausea, dizziness, numbness in hands. Sign: syncope, dreaming, twitching/jerking, hypotension, hypoglycemia (BG 43). Syncope lasted for about 1 minute.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoglycaemia, Muscle twitching, Nausea, Syncope
Clinical narrative: Symptom: Nausea, dizziness, numbness in hands. Sign: syncope, dreaming, twitching/jerking, hypotension, hypoglycemia (BG 43). Syncope lasted for about 1 minute.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Infection, Rash
Clinical narrative: Client received MCV4 vaccine in AM and had small rash by PM. The next AM, client went to doctor and received antibiotics for infection. Rash was gone next AM.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: (R) arm started aching 3 PM 10/25/10 - by 4PM same day could not lift arm in front or to side of her. 10/25/10 PM woke pt. from sleep with throbbing pain. 10/26/10 - Continue with throbbing pain - as day progressed pain not as severe. 10/27/10 = Fine pain went away. 10/31/10 Normal activity - 4 PM pain, problems lifting arm - Applied heat (which made worse) & took MOTRIN. 10/31/10 pain woke pt. up - 11-1-10 AM unable to lift arm up in front or to side. At times pain & throbbing less severe with movement. 11-1-10 Still with throbbing pain in (R) arm - Advised to seek medical treatment.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Bursa disorder, Grip strength decreased, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: 10/25/10 Immediately after injection arm sore down to (R) wrist - sharp pain rest of the day - pain got worse as day progressed & numbness (R) hand - Pain kept pt. awake, unable to sleep on (R) arm - Pain continues - Sat. AM 10/31/10 could not move (R) arm up or out Sun. AM 10/31/10 - Continued pain with numbness from wrist on down. 3:15p 11/2/10 saw PMD - based on assessment Dr felt bursa got punctured/inflammation - Given steroid injection - Rx for primidone 50 mg (PRN: No improvement by Monday 11/8/10 to see PMD again (Note: No firm grip with (R) hand - pt. did mention she was able to fasten bra (able to lift arm behind back).
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: 10/25/10 Immediately after injection arm sore down to (R) wrist - sharp pain rest of the day - pain got worse as day progressed & numbness (R) hand - Pain kept pt. awake, unable to sleep on (R) arm - Pain continues - Sat. AM 10/31/10 could not move (R) arm up or out Sun. AM 10/31/10 - Continued pain with numbness from wrist on down. 3:15p 11/2/10 saw PMD - based on assessment Dr felt bursa got punctured/inflammation - Given steroid injection - Rx for primidone 50 mg (PRN: No improvement by Monday 11/8/10 to see PMD again (Note: No firm grip with (R) hand - pt. did mention she was able to fasten bra (able to lift arm behind back).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pain, Rash macular, Urticaria
Clinical narrative: Red hives, splotches full body, painful. Also attached office notes.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Cyanosis, Fall, Head injury, Pallor, Pulse pressure decreased
Clinical narrative: Walked to the parking lot following the injection. Had a syncopal episode at their car about 6-9 minutes after her injection. Witnessed by MOC. Child fell striking her head on the ground. MOC states daughter's lips were blue and she was unresponsive. MOC started CPR and called emergency. Sent son inside to get me. When I arrived the girl was responsive with eyes open. She could answer simple questions correctly and follow commands. Hand grips were equilaterally strong. She could wiggle her toes bilaterally and her pupils appeared even and she could track with her eyes. Her complexion was pasty pale and a weak pulse was present. At that time emergency vehicles were there and she was transported by ambulance to the local hospital for further evaluation. 11/05/10 heard back from MOC today. She states pt is much better. She took her into her PCP today to double check everything and pt is back to normal.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Walked to the parking lot following the injection. Had a syncopal episode at their car about 6-9 minutes after her injection. Witnessed by MOC. Child fell striking her head on the ground. MOC states daughter's lips were blue and she was unresponsive. MOC started CPR and called emergency. Sent son inside to get me. When I arrived the girl was responsive with eyes open. She could answer simple questions correctly and follow commands. Hand grips were equilaterally strong. She could wiggle her toes bilaterally and her pupils appeared even and she could track with her eyes. Her complexion was pasty pale and a weak pulse was present. At that time emergency vehicles were there and she was transported by ambulance to the local hospital for further evaluation. 11/05/10 heard back from MOC today. She states pt is much better. She took her into her PCP today to double check everything and pt is back to normal.
Age: 61.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema
Clinical narrative: Redness along the skin of (L) deltoid area from 11/9/2010. Tetanus vaccine. No treatment.
Age: 0.22
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: 2 mo imms given 11/11/10. Fever that night 102. Managed with TYLENOL. Seen in clinic 11/12/10 afebrile.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Cough, Headache, Influenza like illness, Pain
Clinical narrative: Itchy rash started 1am on 11/9/10 - covered legs, hands, torso, face, head. Rash still present on body 11/12/10 AM. Took BENADRYL and is going to try some Cortisol cream (11-12-10). Flu-like symptoms 11/8/10 evening (aches/headache/temperature/cough - those subsided.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Rash pruritic
Clinical narrative: Itchy rash started 1am on 11/9/10 - covered legs, hands, torso, face, head. Rash still present on body 11/12/10 AM. Took BENADRYL and is going to try some Cortisol cream (11-12-10). Flu-like symptoms 11/8/10 evening (aches/headache/temperature/cough - those subsided.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: Fever reaching 102.8. Severe headache. Stomach ache. All over muscle and body aches. Tiredness. Chills. Sore joints. Pain at injection site. Fever lasted two days.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Myalgia, Pain, Pyrexia
Clinical narrative: Fever reaching 102.8. Severe headache. Stomach ache. All over muscle and body aches. Tiredness. Chills. Sore joints. Pain at injection site. Fever lasted two days.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Blindness, Dizziness, Headache, Hypoaesthesia
Clinical narrative: Edema, dizziness, headaches, itching, pain in joint, skin burning sensation, tingling in hands, numbness on half of the head. Vision loss, muscle aches.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Myalgia, Oedema, Paraesthesia, Pruritus, Skin burning sensation
Clinical narrative: Edema, dizziness, headaches, itching, pain in joint, skin burning sensation, tingling in hands, numbness on half of the head. Vision loss, muscle aches.
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose, Electrocardiogram, Fear of needles, Laboratory test, Nausea
Clinical narrative: Medication suspected of leading to the adverse reaction: Tetanus, diphtheria, and acellular pertussis vaccine - Tdap--0.5mL/IM- medications suspected of contributing or leading to the adverse reactions: Pt had similar experience to needles prior to the encounter. Reaction preventable -e.g., inappropriate or lack of dose adjustment, excessive dosing, known drug interaction, drug allergies, other contraindications, or inappropriate drug administration technique: No. Type of reaction: Idiosyncratic - unanticipated rare adverse reaction not dose related. Likelihood that the reaction was a result of the medication: Doubtful -no reasonable temporal relationship between the reaction and the drug. Result of the reaction on the level of care: Laboratory tests performed, observation initiated/increased, oxygen administered, vital signs monitoring initiated/increased. Outcome: pt. slid to floor, pale, not breathing, postured, seizure lasting 20 sec. pt. came around and A&O x3. Incident description: pt. was a visitor to facility and getting a Tdap vaccine. Pt. found on floor by elevator pale, not breathing then went into posturing. Possible seizure x20secs. pt. came around alert and oriented x3, still pale and nauseous to ED for assessment. Pt. stated she has fear of needles and does faint with them. Friends confirmed fear and went with pt. to ED.
Sex: F
Vaccine: TDAP
Symptoms: Pallor, Posture abnormal, Respiratory arrest
Clinical narrative: Medication suspected of leading to the adverse reaction: Tetanus, diphtheria, and acellular pertussis vaccine - Tdap--0.5mL/IM- medications suspected of contributing or leading to the adverse reactions: Pt had similar experience to needles prior to the encounter. Reaction preventable -e.g., inappropriate or lack of dose adjustment, excessive dosing, known drug interaction, drug allergies, other contraindications, or inappropriate drug administration technique: No. Type of reaction: Idiosyncratic - unanticipated rare adverse reaction not dose related. Likelihood that the reaction was a result of the medication: Doubtful -no reasonable temporal relationship between the reaction and the drug. Result of the reaction on the level of care: Laboratory tests performed, observation initiated/increased, oxygen administered, vital signs monitoring initiated/increased. Outcome: pt. slid to floor, pale, not breathing, postured, seizure lasting 20 sec. pt. came around and A&O x3. Incident description: pt. was a visitor to facility and getting a Tdap vaccine. Pt. found on floor by elevator pale, not breathing then went into posturing. Possible seizure x20secs. pt. came around alert and oriented x3, still pale and nauseous to ED for assessment. Pt. stated she has fear of needles and does faint with them. Friends confirmed fear and went with pt. to ED.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Patient had syncope approximately 10 minutes after administration of GARDASIL (second in series). Had syncopal episode after administration of vaccines (Tdap, MENACTRA, GARDASIL #1) on 8/25/10. Did not report because we felt it was due to setting 3 shots at once.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: (R) arm swollen with erythema from shoulder to 2" above elbow. Warm, nontender. Dx - localized allergic rx.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Diffuse itchy varicelliform rash.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Musculoskeletal pain
Clinical narrative: Reported 10/29/10 07:03AM per mother. Varicella shot site red, hot, tender to touch, pain to shoulder. 08:30AM exam in office per doctor. Noted 6 cm diameter erythema. Tx with CLINDAMYCIN 150mg QID x 7 days.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Cognitive disorder, Fatigue, Headache, Neuropsychological test, Vaccine positive rechallenge
Clinical narrative: Fatigue headaches cognitive issues (neuropsych testing confirmed no A.D.D. & no processing disorder).
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: 2.5 cm subcutaneous swelling at (L) deltoid injection site.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Sensation of heaviness, Sensory loss
Clinical narrative: Patient described arm as numb, heavy no feeling. No treatment. Mom states lasted 2 days with last dose of HPV.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Red, rashy area, warm to touch, itch, hard around injection site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pt felt pain at injection site last evening, felt she was running fever so took TYLENOL and applied ice to area. Less swollen today. Area red swollen, hot to touch - 9"x7" will continue ice and TYLENOL. Will report tomorrow.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 45mm redness, warmth at injection site noticed approximately 9 hours after administration.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site reaction, Irritability, Local reaction
Clinical narrative: Large local reaction (2 1/2 - 3"), cranky to PREVNAR - 13 booster (R) thigh.
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling and painful.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Quality of life decreased, Urticaria
Clinical narrative: I already had a case of the shingles on July 10-2009. They finally cleared all out about November, but the pains were very bad. I got some nutritional I.V.'s and built up my Immune. In March I had another light attack of shingles. One day my Dr approached me and told me to get the vaccine for the shingles. Soon Aug 11-2010 I did. A month later I got the hives and I have been suffering with that ever since. I do have allergies. I did not know if you have allergies, do not get the vaccine. My Dr knew that I had allergies. How do I get cleared from the hives. I am going to an allergist. I can't seem to get better. I have been taking ALLEGRA. I have the hives all over my body, it has really ruined my life. If you know of any information to help me, please let me know.
Age: 73.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Catheterisation cardiac normal, Hyperhidrosis, Non-cardiac chest pain, Ultrasound abdomen abnormal
Clinical narrative: Initial report received from an investigator on 21 December 2009 under the reference number FUF14. A 73-year-old female subject experienced chest pain 106 days after receiving a second dose of study product H1N1 (30 mcg HA, Group 3), lot number UD12416 on 27 August 2009. The subject experienced sweating and chest pain under her rib cage (both sides) on 11 December 2009. The subject went to the emergency room (dates not provided) and was admitted to the hospital for heart catheterization that was normal. The subject was diagnosed with air pockets in the abdomen after an abdominal ultrasound, and was started on PROTONIX. The subject is to have a follow-up ultrasound in 6 months. Hospitalization dates were not provided. The subject recovered from the chest pain 4 days after onset. The subject remained in the study trial. According to the investigator, the event of chest pain was not related to the study product. The unblinding information for this study was received on 25 October 2009. Follow-up information was received 05 January 2010 from the investigator. The subject, who had a past medical history of hypertension, had previously received a first dose of study vaccine on 06 August 2009. The event diagnosis was amended by the investigator to non-cardiac chest pain which began 09 December 2009 and ended 11 December 2009 (previously reported as chest pain with a start date of 11 December 2009 and stop date of 15 December 2009), which changed the event latency from 106 days to 104 days post vaccination. The investigator clarified that the subject had experienced two separate episodes of chest pain; one episode on 09 December 2009 and a second episode on 11 December 2009; the patient was hospitalized on 11 December 2009 following the second episode. Diagnostic tests included an abdominal ultrasound on 09 December 2009 which revealed air pockets present. On 14 December 2009, a left heart catheterization was performed which showed normal function. Following the ultrasound and heart catheterization, the subject was diagnosed with non-cardiac chest pain. On 15 December 2009, the subject was discharged and scheduled for a six month follow-up ultrasound. The subject recovered from the event on 11 December 2009 (previously reported as 15 December 2009). According to the investigator, the event of non-cardiac chest pain was not related to the study vaccine or concomitant medications. Documents held by sender: None.