chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Lumbar puncture normal, Myalgia, Nausea, Nuclear magnetic resonance imaging brain normal, Pain in extremity
Clinical narrative: Patient received the vaccination mid morning and within 30 minutes she developed a headache with described as "a sharp pain going through my head". (this same headache occurred after anthrax #1 in May 2010 and lasted x 2 weeks). By the evening she also developed multiple bouts of watery diarrhea, nausea and intermittent vomiting. She also developed generalized muscle and joint pain, clammy skin, hot and cold sensations and fatigue. The headache continued unabated. Two days later she sought evaluation in the Medical Clinic with Dr. She was given PHENERGAN, diarrhea medication and sent home for 3 days. She also took ibuprofen and ate a "BRAT" diet. After 2 weeks the nausea, diarrhea, hot/cold sensations dissipated. But the headache continued unabated and muscle/joint pain in the lower extremities continued. Current Symptoms: Presently the patient reports she has a continuous headache that worsens with bright light and loud sounds. She also has pain in the legs from just above the ankles to above the knee caps that never resolves. Around Thanksgiving this lower extremity pain worsened, even the weight of bed sheets were intolerable. She denies numbness, tingling, spasm, fasciculation, swelling and redness of the extremities muscles and joints. She states touch or massaging the legs makes it worse as well as activity including walking. She states she can stand for only 15-20 minutes before the pain forces her to sit/lie down. Stretching and weather changes do not affect the pain level. Sometimes the pain is worse on one side than another and there is no pattern to this alternating intensity. Headache has now lasted continually for 4 months. Lower extremity pain continues also. She is unable to work and needs to be prone all the time. She is now on Workmans' Comp. All evaluation has been negative. Trials of 5 migraine prophylactic drugs have been ineffective. Patient is a civilian employee. The Vaccine Healthcare Center was consulted due to the morbidity and chronicity of sxs.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Red blood cell sedimentation rate normal, Thyroid function test normal, Urine analysis normal, Vomiting
Clinical narrative: Patient received the vaccination mid morning and within 30 minutes she developed a headache with described as "a sharp pain going through my head". (this same headache occurred after anthrax #1 in May 2010 and lasted x 2 weeks). By the evening she also developed multiple bouts of watery diarrhea, nausea and intermittent vomiting. She also developed generalized muscle and joint pain, clammy skin, hot and cold sensations and fatigue. The headache continued unabated. Two days later she sought evaluation in the Medical Clinic with Dr. She was given PHENERGAN, diarrhea medication and sent home for 3 days. She also took ibuprofen and ate a "BRAT" diet. After 2 weeks the nausea, diarrhea, hot/cold sensations dissipated. But the headache continued unabated and muscle/joint pain in the lower extremities continued. Current Symptoms: Presently the patient reports she has a continuous headache that worsens with bright light and loud sounds. She also has pain in the legs from just above the ankles to above the knee caps that never resolves. Around Thanksgiving this lower extremity pain worsened, even the weight of bed sheets were intolerable. She denies numbness, tingling, spasm, fasciculation, swelling and redness of the extremities muscles and joints. She states touch or massaging the legs makes it worse as well as activity including walking. She states she can stand for only 15-20 minutes before the pain forces her to sit/lie down. Stretching and weather changes do not affect the pain level. Sometimes the pain is worse on one side than another and there is no pattern to this alternating intensity. Headache has now lasted continually for 4 months. Lower extremity pain continues also. She is unable to work and needs to be prone all the time. She is now on Workmans' Comp. All evaluation has been negative. Trials of 5 migraine prophylactic drugs have been ineffective. Patient is a civilian employee. The Vaccine Healthcare Center was consulted due to the morbidity and chronicity of sxs.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Severe headache soon after administration (~30-60mins) lasting 18 hours. HA did resolve and has not returned.Denies any other symptoms or reaction.
Age: 35.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Chest discomfort, Pruritus, Swelling face, Throat tightness, Urticaria
Clinical narrative: Hives, itching, facial swelling, tightness of the chest and throat
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia facial, Migraine, Nausea, Pain in extremity, Toothache
Clinical narrative: Migraine headaches numbness in face nausea arms ache teeth ache.
Age: 42.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Pruritus, Rash, Skin warm, Swelling
Clinical narrative: Patient noticed rash, swelling and itching the morning after her vaccination. The rash and swelling area became larger each day accompanied by warmness to the touch.
Age: 73.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Abasia, Hypoaesthesia
Clinical narrative: Reported by pt's spouse: Pt. took last oral typh. capsule 1/13/11; on 1/14/11 pt c/o numbness right leg initially progressing to numbness both legs and from waist down and unable to walk.  Pt. took first dose oral typhoid 1/7/11.
Age: 24.0
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Electrocardiogram normal, Heart rate irregular, Nausea
Clinical narrative: Dizziness, nausea, feeling of irregular heart rate. Had driven three days from state to state (elevation 7,220 ft)just prior to receiving vaccine.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Angioedema, Hypersensitivity, Pruritus, Pyrexia, Urticaria
Clinical narrative: systemic urticaria, angioedema, itching, fever
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: swelling of upper arm
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Injection site pain, Pain in extremity, Pruritus, Rash
Clinical narrative: Few days after vaccine had rash, itching, hives. Likely low grade allergic reaction. Now improving. Still some pain at injection site and pain in legs.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Few days after vaccine had rash, itching, hives. Likely low grade allergic reaction. Now improving. Still some pain at injection site and pain in legs.
Age: 19.0
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 20.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: 0900 (appx) - received flu vax, intranasal 1600 (appx) - rash, itchiness on upper neck, down back to lumbar area (hives) 1645 (appx) - evaluated, administered one 25 mg diphenhydramine P.O.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: 1-7-11 Father of this teen reports rash on face, back and stomach that appeared the morning after the flu vaccine. Reports rash seems to be getting worse. Encouraged him to take her to doctor. 1-13-11 Talked with pts dad, rash has resolved. Did not see a doctor and required no treatment.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pruritus, Rash
Clinical narrative: Rash upper chest & neck < 24 hours after receiving PNEUMOVAX & flu vaccines - pruritis same area - no swelling of face or lips, no SOB.
Age: 22.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Pt arm became red swollen & patient developed low grade fever. Arm was very sore day after injection. 2 days from injection pt was seen at UC & given antibiotics for possible infection. Antibiotic was cephalexin for 10 days.
Age: 34.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Asthenia, Hypoaesthesia, Myalgia, Nausea, Paraesthesia
Clinical narrative: Facial/tongue swelling, myalgia, nausea, vomiting, weakness, numbness & tingling in arms and legs.
Age: 34.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Swelling face, Swollen tongue, Vomiting
Clinical narrative: Facial/tongue swelling, myalgia, nausea, vomiting, weakness, numbness & tingling in arms and legs.
Age: 1.91
Sex: F
Vaccine: DTAP, FLU3, HEPA, PNC13
Symptoms: Pyrexia, Urticaria
Clinical narrative: Child developed low grade fever of 99.4 on 01-05-11 around 9 pm - medicated with BENADRYL and fever subsided. Hives developed thru the night on sides, back, abdomen, legs, then face. Child was taken to pediatrician on 01-06-11 and treated with BENADRYL and steroid.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphonia, Injection site nodule, Laryngitis, Malaise, Rash
Clinical narrative: Patient called 1/8/11 reporting raspy voice, laryngitis & all over malaise which she attributes to ZOSTAVAX 17 days ago, as well as a knot @ injection site & localized rash which have resolved. She has not seen MD for this.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood triglycerides, Decreased appetite, Dyspnoea, Injection site erythema, Laryngitis
Clinical narrative: Patient called 1/8/11 reporting raspy voice, laryngitis & all over malaise which she attributes to ZOSTAVAX 17 days ago, as well as a knot @ injection site & localized rash which have resolved. She has not seen MD for this.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Sputum discoloured, Upper extremity mass
Clinical narrative: Patient called 1/8/11 reporting raspy voice, laryngitis & all over malaise which she attributes to ZOSTAVAX 17 days ago, as well as a knot @ injection site & localized rash which have resolved. She has not seen MD for this.
Age: 59.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Fatigue, Headache, Lymphadenopathy, Pain, Tenderness
Clinical narrative: Bilateral axillary lymphadenopathy & tenderness, fatigue, headache, body aches x 1 week.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash macular
Clinical narrative: Patient received MMR/VARIVAX on 12/27/10 he developed fever of 10-102 on 1/3/11. Diffuse rashes (macular) started on 1/4/11. Rashes became generalized.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Mood altered
Clinical narrative: Parent reports redness, tenderness, hardness, warmth at injection site developing 7-8 days post-vaccination. Mood changes and low grade fever x 24 hours. Patient also teething at this time. Examined by pediatrician (MD) who prescribed KEFLEX 250 mg BID x 10 days. Injection site = left anterolateral thigh, SQ.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Parent reports redness, tenderness, hardness, warmth at injection site developing 7-8 days post-vaccination. Mood changes and low grade fever x 24 hours. Patient also teething at this time. Examined by pediatrician (MD) who prescribed KEFLEX 250 mg BID x 10 days. Injection site = left anterolateral thigh, SQ.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Mood altered
Clinical narrative: Parent reports redness, tenderness, hardness, warmth at varicella injection site developing 11-12 days post-vaccination. Mood changes also experienced. Patient also teething at this time. Examined by pediatrician (MD) who prescribed KEFLEX 250 mg BID x 10 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: I was red and warm to touch around the injection site. It started the day of the vaccination and got larger. Patient went to her MD and MD diagnosed it as cellulitis. Patient got BACTRIM DS to treat it 2 days after getting the vaccination and it started to get better 2 days after starting antibiotic.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling & pain at site of injection approx 2" no fever or other symptoms.
Age: 41.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient received PNEUMOVAX injection into left deltoid on 1/11/11 - has had swelling, redness and pain.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 1/12 day after administration site - swollen - red - hot - hard. Some improvement noted next day 1-13.
Age: 0.38
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site erythema, Injection site mass, Injection site rash
Clinical narrative: Small area of redness (+) rash at inj. site, bump.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood gases normal, Chest X-ray, Fibrin D dimer, Full blood count, Metabolic function test
Clinical narrative: Hands & feet looked bluish within a few hours after 3rd Gardasil vaccine. Was seen at ER and Hosp. Labs normal. Prescibed steroids but took only 1 dose.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell sedimentation rate, Skin discolouration
Clinical narrative: Hands & feet looked bluish within a few hours after 3rd Gardasil vaccine. Was seen at ER and Hosp. Labs normal. Prescibed steroids but took only 1 dose.
Age: 1.27
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever 101- 103.5 began 10 days after administration of MMR and Pentacel vaccines. Fever is gone but now has rash.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site swelling
Clinical narrative: 7x8cm firm swelling at site of PENTACEL injection, (R) lateral-ant thigh. No treatment.
Age: 1.07
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Pt was given MMR vaccine and within 2 minutes a 1.5 cm urticaria was present with 1 cm of redness surrounding the injection site on the (L) arm mom instructed to give BENADRYL q 6 hrs. Pt active with no mental status changes or activity changes.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received Tdap in left arm - deltoid - on 1/3/11.  Pain and swelling @ injection site x 2 days.  1/6/11:  onset of redness, swelling, increased warmth extending to elbow.  Temp 1/6/11:  98.7F.  1/6/11 seen @ Urgent Care.  MD treated client for allergic reaction to vaccine.  Started on Prednisone 10 mg (6 day tapered dose), OTC Benadryl, Tylenol PRN.  To return to PMD 1/12/11 if not improved. 1/10/11:  Phone call to client:  swelling resolved, slight redness remains; continues Prednisone as ordered.  Symptoms improving.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: Pt. had swelling at the injection site.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site swelling
Clinical narrative: 7 x 8 cm firm swelling at site of PENTACEL injection, (R) anterolateral thigh. No treatment.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Angioedema, Urticaria
Clinical narrative: The patient developed widespread urticaria and angioedema on the right side of her face.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Hypoaesthesia, Paraesthesia, Polyneuropathy
Clinical narrative: Initial report received from a consumer on 19 Nov 2010: This patient received RABAVERT (batch number) as a part of her pre-exposure prophylaxis exposure series. Three weeks ago on an unknown date, the patient developed paresthesia in the right side of body and pain in right wrist. At the time of this report, the patient was still experiencing the paresthesia (mainly numbness) in the right side. The reporter did not provide causality assessment between the events and RABAVERT vaccine. Follow up received from a consumer on 30 Nov 2010: The patient took rabies vaccine and not RABAVERT (manufacturer unknown; batch number 475011C) for pre-exposure prophylaxis on 08 Oct 2010. Follow-up information received from a physician on 14 Jan 2011: This patient received RABAVERT (4th booster) on 08 Oct 2010. The patient visited the Accident & Emergency Department on 17 Nov 2010 with progressive right-sided sensory polyneuropathy. The patient was hospitalised as a result. At the time of report, the patient outcome was unknown. The reporter suspected a possible causal relationship between the events and RABAVERT.
Age: 31.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Pt received Varicella Vaccine 12-16-10. She called in on 12/17/10 reporting injection site 1 1/2 in red, sore, swollen and itchy. Advised pt apply cool packs & try taking BENADRYL for itch, and if no better or worse to have doctor follow up. Pt RTC today for 2nd set vaccines, brought pictures from phone/Blackberry, 12/18/10 site 6-7 inches in diameter red, sore, swollen with blistery appearance in middle approximately 1.0 cm. Began to clear up Mon 12/20/10 site completely gone today.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Pt came into store 1/9/11 will cellulitis at injection site. She will see MD tomorrow and let us know outcome. Spoke w/MD & received course of KEFLEX, which she has been on since Sunday. Area feels & looks much better, pt says should resolve in a few days.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: ADACEL was administered to patient on Jan 4th. On Jan 5 & 6 the patient experienced sore arm & on Jan 7 & 8, swollen lymph nodes. Pharmacist recommended IBU w/c helped with swelling and pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Injection site rxn - redness.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Fatigue, Injection site discolouration, Injection site erythema, Injection site induration
Clinical narrative: Site following day became sore, redness, and arm aches. Had read info form so felt mild reaction. Iced site and took some TYLENOL. Next day called health dept. unable to get through. Redness increased, hardness at site, warmth, swelling, itchy increased (no fever). Health dept. reached Dec. 16 - related symptoms to staff. May need to contact doctor. Spoke to Dr. prescribed Cephalexin 500 mg. Skin cellulitis. 7 days/reaction symptoms improved. Site center darkened appearance. Tiredness remained into January. Never had vaccine reaction before! Had to pay for antibiotic. Hopefully my insurance will pay health dept for vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Site following day became sore, redness, and arm aches. Had read info form so felt mild reaction. Iced site and took some TYLENOL. Next day called health dept. unable to get through. Redness increased, hardness at site, warmth, swelling, itchy increased (no fever). Health dept. reached Dec. 16 - related symptoms to staff. May need to contact doctor. Spoke to Dr. prescribed Cephalexin 500 mg. Skin cellulitis. 7 days/reaction symptoms improved. Site center darkened appearance. Tiredness remained into January. Never had vaccine reaction before! Had to pay for antibiotic. Hopefully my insurance will pay health dept for vaccine.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Asthenia, Back pain, Fatigue, Feeling abnormal
Clinical narrative: I have gotten seasonal influenza vaccines before, and had a prior adverse reaction in 1999, stopped getting them for a couple years, and then started getting them again in 2002 during pregnancy at the urge of my doctor with no side effect. This shot was the seasonal influenza with H1N1 for the 2010 flu year. Initially, significant swelling and bruising at vaccine site. Within hours was extremely sleepy, felt weak. Slept almost constantly for 3 days following the vaccine, other then getting up to eat. Felt weak, tired, drained, abnormal. This led to back pain which I believe was due to being bedridden in sleep for days because of vaccine. This acute back pain caused me to miss work for two weeks. There was a painful knot at vaccine site for weeks.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Gait disturbance, Hypersomnia, Injection site haematoma, Injection site nodule, Injection site pain
Clinical narrative: I have gotten seasonal influenza vaccines before, and had a prior adverse reaction in 1999, stopped getting them for a couple years, and then started getting them again in 2002 during pregnancy at the urge of my doctor with no side effect. This shot was the seasonal influenza with H1N1 for the 2010 flu year. Initially, significant swelling and bruising at vaccine site. Within hours was extremely sleepy, felt weak. Slept almost constantly for 3 days following the vaccine, other then getting up to eat. Felt weak, tired, drained, abnormal. This led to back pain which I believe was due to being bedridden in sleep for days because of vaccine. This acute back pain caused me to miss work for two weeks. There was a painful knot at vaccine site for weeks.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling, Somnolence
Clinical narrative: I have gotten seasonal influenza vaccines before, and had a prior adverse reaction in 1999, stopped getting them for a couple years, and then started getting them again in 2002 during pregnancy at the urge of my doctor with no side effect. This shot was the seasonal influenza with H1N1 for the 2010 flu year. Initially, significant swelling and bruising at vaccine site. Within hours was extremely sleepy, felt weak. Slept almost constantly for 3 days following the vaccine, other then getting up to eat. Felt weak, tired, drained, abnormal. This led to back pain which I believe was due to being bedridden in sleep for days because of vaccine. This acute back pain caused me to miss work for two weeks. There was a painful knot at vaccine site for weeks.
Age: 2.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Cyanosis, Febrile convulsion
Clinical narrative: Febrile seizure, turned blue, so called 911 and ambulance took patient to hospital.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haematoma
Clinical narrative: Patient noticed at site of vaccination it looked red or she said it appeared bruised to her. She did not come to pharmacy until 6 days after she initially saw the area. I encouraged the patient to go on to physician and let us know immediately what the doctor said. I also encouraged patient to always contact pharmacy as soon as anything like that happens with a vaccine or any medication. The importance of prompt assistance is crucial.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Acne, Blister, Erythema, Feeling abnormal, Pyrexia
Clinical narrative: As described by MOC- Child developed low-grade fever and "felt bad" the evening following immunizations. The following morning (1/20/11)child began developing "a couple" lesions described as beginning like "small, red pimple-like blisters, and starting to turn into welts" on his bottom and back. All are small in size except one on his back which is approximately the size of a silver dollar. Child has not been complaining of itching, pain, or SOB.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Skin lesion, Urticaria
Clinical narrative: As described by MOC- Child developed low-grade fever and "felt bad" the evening following immunizations. The following morning (1/20/11)child began developing "a couple" lesions described as beginning like "small, red pimple-like blisters, and starting to turn into welts" on his bottom and back. All are small in size except one on his back which is approximately the size of a silver dollar. Child has not been complaining of itching, pain, or SOB.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Pt reports she had pain at the time of injection. She noticed that on the AM on the 12th there was a lump and swelling at the site of the left upper arm. The lump continued to get harder and bigger, with redness increasing over the back of the arm, to the elbow. She reports it gradually got worse, and then she came into an appointment. After starting on ATB it was improving in 48 hours.
Age: 1.68
Sex: M
Vaccine: DTAP, FLUX, FLUX(H1N1), IPV
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Low grade fever 100.5 Sunday night and Monday morning.  Diarrhea started Monday evening and still continues today 1/20/11.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Brain stem auditory evoked response, Computerised tomogram head, Convulsion, Deafness, Electroencephalogram
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pneumococcal meningitis in a 3-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PREVNAR 13 (unspecified manufacturer), Haemophilius influenza type b vaccine (Sanofi Pasteur MSD, Hib vaccine) and ROTATEQ (Merck). The subject's medical history included fetal distress syndrome. Birth weight was 8 pounds and 7 ounces, with a length of 52.1 cm and a head circumference of 36.1 cm. Concurrent medical conditions included hematochezia and milk allergy. On 4 August 2010 the subject received unspecified dose of PREVNAR 13 intramuscularly in the left leg. On the same day, the subject also received unspecified dose of HIB vaccine intramuscularly in the right leg. Later, on 17 August 2010 the subject received unspecified dose of ROTATEQ (oral) as well as an unspecified dose of intramuscular PEDIARIX in the right leg. On 17 September 2010, 31 days after vaccination with PEDIARIX and ROTATEQ, 44 days after vaccination with Hib vaccine and PREVNAR 13, the subject experienced upper respiratory infection with fever. The following day, on 18 September 2010, the subject's condition worsened with fussiness, pallor, bulging fontanelle and otitis media. The next day, on 19 September 2010, the subject had strep pneumo meningitis and experienced a seizure. The subject was hospitalised for 14 days. It was noted that "the medication" was ineffective. At the time of reporting the outcome of the events was unspecified. It was noted that "the vaccine" was administered by a healthcare professional. The medication was stored appropriately and not altered in any way. The subject's developmental milestones and physical growth were all normal. It as reported that the subject was recovering from the events with mild hearing loss.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Fontanelle bulging, Irritability, Laboratory test, Lumbar puncture, Meningitis pneumococcal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pneumococcal meningitis in a 3-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PREVNAR 13 (unspecified manufacturer), Haemophilius influenza type b vaccine (Sanofi Pasteur MSD, Hib vaccine) and ROTATEQ (Merck). The subject's medical history included fetal distress syndrome. Birth weight was 8 pounds and 7 ounces, with a length of 52.1 cm and a head circumference of 36.1 cm. Concurrent medical conditions included hematochezia and milk allergy. On 4 August 2010 the subject received unspecified dose of PREVNAR 13 intramuscularly in the left leg. On the same day, the subject also received unspecified dose of HIB vaccine intramuscularly in the right leg. Later, on 17 August 2010 the subject received unspecified dose of ROTATEQ (oral) as well as an unspecified dose of intramuscular PEDIARIX in the right leg. On 17 September 2010, 31 days after vaccination with PEDIARIX and ROTATEQ, 44 days after vaccination with Hib vaccine and PREVNAR 13, the subject experienced upper respiratory infection with fever. The following day, on 18 September 2010, the subject's condition worsened with fussiness, pallor, bulging fontanelle and otitis media. The next day, on 19 September 2010, the subject had strep pneumo meningitis and experienced a seizure. The subject was hospitalised for 14 days. It was noted that "the medication" was ineffective. At the time of reporting the outcome of the events was unspecified. It was noted that "the vaccine" was administered by a healthcare professional. The medication was stored appropriately and not altered in any way. The subject's developmental milestones and physical growth were all normal. It as reported that the subject was recovering from the events with mild hearing loss.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Nuclear magnetic resonance imaging brain, Otitis media, Pallor, Pyrexia, Upper respiratory tract infection
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pneumococcal meningitis in a 3-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PREVNAR 13 (unspecified manufacturer), Haemophilius influenza type b vaccine (Sanofi Pasteur MSD, Hib vaccine) and ROTATEQ (Merck). The subject's medical history included fetal distress syndrome. Birth weight was 8 pounds and 7 ounces, with a length of 52.1 cm and a head circumference of 36.1 cm. Concurrent medical conditions included hematochezia and milk allergy. On 4 August 2010 the subject received unspecified dose of PREVNAR 13 intramuscularly in the left leg. On the same day, the subject also received unspecified dose of HIB vaccine intramuscularly in the right leg. Later, on 17 August 2010 the subject received unspecified dose of ROTATEQ (oral) as well as an unspecified dose of intramuscular PEDIARIX in the right leg. On 17 September 2010, 31 days after vaccination with PEDIARIX and ROTATEQ, 44 days after vaccination with Hib vaccine and PREVNAR 13, the subject experienced upper respiratory infection with fever. The following day, on 18 September 2010, the subject's condition worsened with fussiness, pallor, bulging fontanelle and otitis media. The next day, on 19 September 2010, the subject had strep pneumo meningitis and experienced a seizure. The subject was hospitalised for 14 days. It was noted that "the medication" was ineffective. At the time of reporting the outcome of the events was unspecified. It was noted that "the vaccine" was administered by a healthcare professional. The medication was stored appropriately and not altered in any way. The subject's developmental milestones and physical growth were all normal. It as reported that the subject was recovering from the events with mild hearing loss.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Neutrophil count increased, Smear cervix, Smear vaginal abnormal
Clinical narrative: This initial foreign regulatory report (ADR20874085) received from the Medicines and Healthcare Products Regulatory Agency on 12 Jan 2011 has been transcribed from an Anonymised Single Patient Report: This pregnant patient received seasonal influenza virus vaccine (manufacturer and batch number unknown) on 09 Dec 2010. On 17 Dec 2010, an ultrasound was performed,  which showed normal foetal. On 18 Dec 2010, the patient presented with miscarriage of pregnancy. The patient was 20 weeks pregnant at the time of miscarriage. A clinical investigation on the same day revealed increased values for neutrophils (14.43) and white blood cell count (19.2). No unit and reference ranges were reported. High vaginal smear showed group B streptococci. There was no evidence of toxoplasma, cytomegalovirus or rubella IgM. The physician's causality assessment was not reported.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Streptococcal infection, Streptococcus test positive, Ultrasound antenatal screen normal, White blood cell count increased
Clinical narrative: This initial foreign regulatory report (ADR20874085) received from the Medicines and Healthcare Products Regulatory Agency on 12 Jan 2011 has been transcribed from an Anonymised Single Patient Report: This pregnant patient received seasonal influenza virus vaccine (manufacturer and batch number unknown) on 09 Dec 2010. On 17 Dec 2010, an ultrasound was performed,  which showed normal foetal. On 18 Dec 2010, the patient presented with miscarriage of pregnancy. The patient was 20 weeks pregnant at the time of miscarriage. A clinical investigation on the same day revealed increased values for neutrophils (14.43) and white blood cell count (19.2). No unit and reference ranges were reported. High vaginal smear showed group B streptococci. There was no evidence of toxoplasma, cytomegalovirus or rubella IgM. The physician's causality assessment was not reported.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood creatine phosphokinase increased, Chest discomfort, Headache, Myalgia, Palpitations
Clinical narrative: Headache, muscle aches, chest tightness, unable to focus and palpitations.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: Headache, muscle aches, chest tightness, unable to focus and palpitations.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Localised oedema, Pain
Clinical narrative: Localized pain, erythema, & edema tx ice & MOTRIN.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Tenderness
Clinical narrative: Right arm tender with 3" x 7" red area on morning after receiving immunization. Pt self-medicated with BENADRYL & reported improvement.
Age: 0.52
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Child (6 mo) adm expired dose of ROTATEQ on 12-20-10 per order from Dr. - parent to be called for redose of child - 4 wks from previous dose on or after 1-20-11.
Age: 2.0
Sex: U
Vaccine: FLU3, HEPA, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. developed a raised, red area around injection site approx 24 hrs after injection. Redness spread and were seen 48 hrs after injection, was clearing up at that point.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Given client expired Rotavirus; had client to wait 15 min after med given; no problem noted. Inform Dr. and supervisor. Will call or send letter to revaccinate.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Client given expired Rotavirus, waited 15 min after meds given, no problem noted. Inform Dr. & supervisor. Will call or send letter to revaccinate.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Child (2mo) adm. expired dose of ROTATEQ on 12-30-10 per order of Dr. - parent to be called for redose of child 4-wks from previous dose on or after 1-30-11.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Child (2 mo) adm. expired dose of ROTATEQ on 12-30-10 per order of Dr. parent to be called for redose 4 wks later on 1-30-11 or after.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Child given expired dose oral ROTATEQ 5 (12-8-10) per Dr., parent to be contacted to bring child for redose 4 wks after invalid dose was given.
Age: 0.65
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Given client expired Rotavirus, had client to wait 15 min after meds given; no problem noted inform Dr. & supervisor. Will call or send letter to revaccinate.
Age: 1.1
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Irritability, Pyrexia, Vomiting
Clinical narrative: Awoke at 4:00 am with high fever. Mom gave ADVIL Infant drops and child vomited. Child fussy, crabby and only drinking. Mom didn't take temp. Mom guesses 102-103 temp.
Age: 29.0
Sex: F
Vaccine: YF
Symptoms: Drug exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: No adverse events. Client received yellow fever vaccine on 12/17/10 and learned she was pregnant Jan 8, 2011.
Age: 0.35
Sex: M
Vaccine: PNC13, RV5
Symptoms: Injection site erythema
Clinical narrative: Lt thigh with rough erythema to knee but worse area 3x3 inches.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Given client expired Rotavirus, had client to wait 15 min after meds given; no problem noted. Inform Dr. & supervisor. Will call or send letter to revaccinate.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Baby was given oral ROTATEQ on 1-4-11 and it was expired on 12-8-10. To be called back in for redose of this vaccine 4 weeks from invalid dose, per Dr.
Age: 0.54
Sex: M
Vaccine: RVX
Symptoms: Expired drug administered
Clinical narrative: Client given expired Rotavirus; waited in clinic for 15 min after meds given; no problem noted. Inform doctor & supervisor. Will call or send letter to revaccinate.
Age: 0.46
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Given client expired Rotavirus; had client to wait 15 min after meds given, no problem noted. Inform Dr. and supervisor will call or send letter to revaccinate.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Given client expired Rotavirus; had client to wait 15 min after meds was given; no problem noted. Informed Dr & supervisor will call or send letter to revaccinate.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Child (4 mo) admin. expired dose of ROTATEQ on 12-14-10 per order from Dr. parent to be called for redose of child 4 wks from previous dose on or after 1-14-11.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Child (2mo) adm. expired dose of ROTATEQ on 12-28-10 per order from Dr. - parent to be called for redose of child - 4 wks from previous dose on or after 1-28-11.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Child dosed with expired (12-8-10) ROTATEQ oral on 12-28-10 per Dr. instruction parent called to bring child for redose on 1-28-11 (4 wks after invalid dose).
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Condition aggravated, Convulsion, Incontinence, Mental status changes
Clinical narrative: Pt has a history of congenital stroke/hemiplegia and epilepsy. His seizures had been controlled on meds. Shortly after receiving PCV 13 -> had several episodes of incontinence and altered mental status -> likely seizures controlled with benzodiazepine.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Rash, Throat irritation, Tremor
Clinical narrative: Initial report received from a nurse via vaccine adverse event reporting system (VAERS; reference number not reported) on 10 Jan 2011: This patient had been previously vaccinated with flu shot in the past and did not have any severe reaction or allergic reaction to it. She was vaccinated with FLUVIRIN (batch number 111812P1) intramuscularly in left arm, on 15 Oct 2010. On the same day, she complained of scratchy throat and shakiness. She developed rash on both arms and had difficulty in breathing. She was given unspecified treatment in emergency room as per hospital protocol. However, duration of hospital stay was not reported. The patient made a complete recovery.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Bone pain, Dizziness, Electroencephalogram, Fatigue, Headache
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter with spring-time allergies and no pertinent medical history who on 30-APR-2010 was vaccinated IM with a 0.5 ml dose of GARDASIL. There was no concomitant medication. The consumer reported that "around the beginning of May 2010" on approximately 01-MAY-2010, her daughter had been experiencing heavy menstrual bleeding, headaches, quivering of the limbs, bone-crushing, fatigue and a series of black-outs since receiving a dose of GARDASIL. The consumer said that her daughter experienced these symptoms mainly on the second day of her period. The consumer said they had gone to see many specialists, including neurologist and cardiologist. On an unspecified date EEG, MRI and annual check-ups tests were performed (results not provided). At the time of the report, the patient had not recovered. Follow up information has been received from a physician. It was reported that the patient with acid reflux and congenital stridor was vaccinated IM in the left arm with the first dose of GARDASIL (lot number 663559/1178Y) on 30-APR-2010 at 16:45. The physician reported that the patient was seen on 31-AUG-2010 due to a second menstrual bleeding for 3 days (second time in that month). The patient experienced dizziness, shaking and near fainting. The physician reported that a similar episode had happened last month. Some dizziness was reported to take place daily and some was "present today." The patient was referred to the gynecologist, cardiologist, ear nose and throat (ENT) and neurology. At the time of the report the patient's outcome was unknown. Patient had a second menstrual bleeding for three days (second time in a month), dizziness, shaking and near fainting were considered to be other important medical events by the physician. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Loss of consciousness, Menorrhagia, Nuclear magnetic resonance imaging, Polymenorrhoea
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter with spring-time allergies and no pertinent medical history who on 30-APR-2010 was vaccinated IM with a 0.5 ml dose of GARDASIL. There was no concomitant medication. The consumer reported that "around the beginning of May 2010" on approximately 01-MAY-2010, her daughter had been experiencing heavy menstrual bleeding, headaches, quivering of the limbs, bone-crushing, fatigue and a series of black-outs since receiving a dose of GARDASIL. The consumer said that her daughter experienced these symptoms mainly on the second day of her period. The consumer said they had gone to see many specialists, including neurologist and cardiologist. On an unspecified date EEG, MRI and annual check-ups tests were performed (results not provided). At the time of the report, the patient had not recovered. Follow up information has been received from a physician. It was reported that the patient with acid reflux and congenital stridor was vaccinated IM in the left arm with the first dose of GARDASIL (lot number 663559/1178Y) on 30-APR-2010 at 16:45. The physician reported that the patient was seen on 31-AUG-2010 due to a second menstrual bleeding for 3 days (second time in that month). The patient experienced dizziness, shaking and near fainting. The physician reported that a similar episode had happened last month. Some dizziness was reported to take place daily and some was "present today." The patient was referred to the gynecologist, cardiologist, ear nose and throat (ENT) and neurology. At the time of the report the patient's outcome was unknown. Patient had a second menstrual bleeding for three days (second time in a month), dizziness, shaking and near fainting were considered to be other important medical events by the physician. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope, Tremor
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter with spring-time allergies and no pertinent medical history who on 30-APR-2010 was vaccinated IM with a 0.5 ml dose of GARDASIL. There was no concomitant medication. The consumer reported that "around the beginning of May 2010" on approximately 01-MAY-2010, her daughter had been experiencing heavy menstrual bleeding, headaches, quivering of the limbs, bone-crushing, fatigue and a series of black-outs since receiving a dose of GARDASIL. The consumer said that her daughter experienced these symptoms mainly on the second day of her period. The consumer said they had gone to see many specialists, including neurologist and cardiologist. On an unspecified date EEG, MRI and annual check-ups tests were performed (results not provided). At the time of the report, the patient had not recovered. Follow up information has been received from a physician. It was reported that the patient with acid reflux and congenital stridor was vaccinated IM in the left arm with the first dose of GARDASIL (lot number 663559/1178Y) on 30-APR-2010 at 16:45. The physician reported that the patient was seen on 31-AUG-2010 due to a second menstrual bleeding for 3 days (second time in that month). The patient experienced dizziness, shaking and near fainting. The physician reported that a similar episode had happened last month. Some dizziness was reported to take place daily and some was "present today." The patient was referred to the gynecologist, cardiologist, ear nose and throat (ENT) and neurology. At the time of the report the patient's outcome was unknown. Patient had a second menstrual bleeding for three days (second time in a month), dizziness, shaking and near fainting were considered to be other important medical events by the physician. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: FLUN3
Symptoms: Activities of daily living impaired, Aspiration, Atelectasis, Autopsy, Computerised tomogram thorax abnormal
Clinical narrative: This is a follow-up to a previously submitted VAERS report 411968-1. Correction - Patient received FluMist vaccine on 10/20/2010 and NOT H1N1 on 11/9/2010 as listed on original VAERS report. His symptom onset was reported to be within days of vaccine receipt, but not limiting activities until 19 Nov 2010. Patient was transferred from one hospital to another. Cause of death was listed as respiratory arrest with evidence of aspiration. Autopsy results are pending.
Age: 41.0
Sex: M
Vaccine: FLUN3
Symptoms: Death, Pleural effusion, Pneumonia, Respiratory arrest
Clinical narrative: This is a follow-up to a previously submitted VAERS report 411968-1. Correction - Patient received FluMist vaccine on 10/20/2010 and NOT H1N1 on 11/9/2010 as listed on original VAERS report. His symptom onset was reported to be within days of vaccine receipt, but not limiting activities until 19 Nov 2010. Patient was transferred from one hospital to another. Cause of death was listed as respiratory arrest with evidence of aspiration. Autopsy results are pending.