chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Erythema, Injection site pain, Skin warm
Clinical narrative: 12/4/2012Patient had pain at the injection site, temperature of 102 with rigors. 12/5/2012 patient seen in clinic with complaint of severe pain at injection site. MD note slight swelling and warmth. 12/6/2012 Patient seen in clinic with three areas of erythema tender and very warm. Patient on augmentin for another infection changed to Cipro and Bactrim.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Swelling, Tenderness
Clinical narrative: 12/4/2012Patient had pain at the injection site, temperature of 102 with rigors. 12/5/2012 patient seen in clinic with complaint of severe pain at injection site. MD note slight swelling and warmth. 12/6/2012 Patient seen in clinic with three areas of erythema tender and very warm. Patient on augmentin for another infection changed to Cipro and Bactrim.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Client reported having pain in left arm approximately 3-4 weeks after vaccine had been administered.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Eyelid disorder, Eyelid oedema, Herpes virus infection, Ocular hyperaemia
Clinical narrative: Reactivated head herpes, but this time in the eyelid. Red eye, swollen lids, pus pockets. Treated with doctors repeatedly. Treated from 11/13/2012 and still 12/12/2012.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Reactivated head herpes, but this time in the eyelid. Red eye, swollen lids, pus pockets. Treated with doctors repeatedly. Treated from 11/13/2012 and still 12/12/2012.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Palpitations, Pharyngeal oedema, Rash macular
Clinical narrative: Patient states started coughing real bad to the point of throwing up. Then she started to feel like her throat was closing up and she could not breathe. At this point her heart was racing and she had to concentrate to breathe. Approx an hour and a half after symptoms started she called the Doctor and proceeded to the Emergency Room.   ER records show dyspnea, swelling of the throat and a generalized macular rash. Prednisone 60mg PO and Benadryl 25mg PO were given at the ER.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness, Vomiting
Clinical narrative: Patient states started coughing real bad to the point of throwing up. Then she started to feel like her throat was closing up and she could not breathe. At this point her heart was racing and she had to concentrate to breathe. Approx an hour and a half after symptoms started she called the Doctor and proceeded to the Emergency Room.   ER records show dyspnea, swelling of the throat and a generalized macular rash. Prednisone 60mg PO and Benadryl 25mg PO were given at the ER.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Feeling hot, Lymph node pain, Pain, Paraesthesia
Clinical narrative: Joints ache, tingling, hot, painful to walk (r/t bones and thighs). Achy when went to bed and woke up with more pain. Tender lymph nodes in groin. Took Advil.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Dyspnoea, Flushing, Lip swelling, Urticaria
Clinical narrative: 20 minutes after receiving DTaP, MMR and Polio Vaccine, child developed generalized hives, flushing, lip swelling, and difficulty breathing.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Lacrimation increased, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, runny nose, cough, body aches and very, very red, watery eyes.
Age: 46.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Dizziness, Headache, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed fever 101 -> 102.7 with dizziness and headache. Site of injection (L) arm swollen, feels hot and tender. 12/08 Temp 101. 12/09 Temp 102.7.
Age: 46.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Patient developed fever 101 -> 102.7 with dizziness and headache. Site of injection (L) arm swollen, feels hot and tender. 12/08 Temp 101. 12/09 Temp 102.7.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, PNC, VARCEL
Symptoms: Injection site induration
Clinical narrative: 4 cm wide induration 1 day post injection at injection site (L) arm.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Skin infection
Clinical narrative: After receiving the shot, pt stated her left back arm turned red and developed a "red ball". She saw her doctor & was told that the vaccination caused a skin infection. She was given cephalexin 500mg, prednisone 20mg & TAC cream.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Received vaccine from Employee Health few hours after receiving vaccine pt c/o "itchy back" - raised red rash over entire torso - resolved within 12 hours.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Headache, Pain
Clinical narrative: Father reports pt. c/o headache approx. 5-6 pm on 12-11-12 that worsened when standing. Declined TYLENOL but symptoms persist, causing pt. to stay home from school.
Age: 26.0
Sex: F
Vaccine: HEPAB, YF
Symptoms: Injection site erythema, Injection site haematoma, Injection site pruritus, Oropharyngeal pain
Clinical narrative: Client had yellow fever vaccine on 11-13-12 & had Hep A B #1 on 11-13-12. States she started itching to (R) arm at injection on site on 11-15-12. The area was red & had bruised according to client. The redness remains at the site is lighter per client - area measured appeared 25 mm L x 25 m W on 12-11-12.
Age: 26.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pt is pregnant at the time approx. 22 wks. FLUZONE that was administered is not preservative free.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Erythema from deltoid to antecubital also edematous and very tender and warm to the touch.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site pruritus, Injection site scab
Clinical narrative: Patients reports hard, internal lump at injection site, size of a baseball. Itchy. Did resolve to small lump, scabbed over.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: 48 hours after receiving flu vaccine pt. developed fever > 102 degrees F; fever; chills; headache; body aches which have persisted 5 days to date.
Age: 1.33
Sex: M
Vaccine: DTAP, FLU3, HIBV
Symptoms: Hypersensitivity, Rash generalised
Clinical narrative: The following morning patient developed a rash on face & body. Went to ED. Was dx as allergic reaction and treated with steroid.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: About 1 hour after immunization, arm began to hurt severely. So much so she went to ER. They said it was ok & sent her home. It has been almost one month and it still hurts so much she can't move it.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Edema & erythema on site of injection 30 x 40 mm in diameter.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: Pt came in showing her arm was bruised. She said it was really sore & is starting to get better.
Age: 20.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Blood glucose increased, Fatigue, Glycosylated haemoglobin increased, Immediate post-injection reaction, Malaise
Clinical narrative: After immunizations given, patient felt immediate malaise, nausea. Blurred vision, polydipsia next day and persisted thereafter with increasing fatigue.
Age: 20.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Nausea, Polydipsia, Vision blurred
Clinical narrative: After immunizations given, patient felt immediate malaise, nausea. Blurred vision, polydipsia next day and persisted thereafter with increasing fatigue.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: The arm is very sore for a long period of time. When she lifts her arm it hurts. She is in pain all the time. She had gotten the shot on 10/5/12. She has sharp shooting pain when she lifts her arm.
Age: 1.35
Sex: M
Vaccine: FLU3
Symptoms: Irritability, Pyrexia, Rash generalised, Upper respiratory tract infection
Clinical narrative: Fever developed 12/7/12 without other symptoms except irritability. Fever x 2 days resolved. URI sx developed 12/10/12 and generalized rash 12/12/12.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Headache, Injection site erythema, Injection site infection, Injection site pain
Clinical narrative: Nov. 7th inj. site swollen down to elbow, painful, hot, red, raised. Fever 100 x 3 days, felt bad, ached all over and had a headache. Saw PCP 11-9-12 told bad infection noted injection site had a darker red core in it, no drainage, but scabbed over. Her skin peeled where she had the injection. She received 3 courses of erythromycin 333mg tid. On 11/12/12 injection site about 50 cent piece size, not painful, not hot, not swollen.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Injection site scab, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Nov. 7th inj. site swollen down to elbow, painful, hot, red, raised. Fever 100 x 3 days, felt bad, ached all over and had a headache. Saw PCP 11-9-12 told bad infection noted injection site had a darker red core in it, no drainage, but scabbed over. Her skin peeled where she had the injection. She received 3 courses of erythromycin 333mg tid. On 11/12/12 injection site about 50 cent piece size, not painful, not hot, not swollen.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Skin exfoliation
Clinical narrative: Nov. 7th inj. site swollen down to elbow, painful, hot, red, raised. Fever 100 x 3 days, felt bad, ached all over and had a headache. Saw PCP 11-9-12 told bad infection noted injection site had a darker red core in it, no drainage, but scabbed over. Her skin peeled where she had the injection. She received 3 courses of erythromycin 333mg tid. On 11/12/12 injection site about 50 cent piece size, not painful, not hot, not swollen.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Fall
Clinical narrative: Pharmacist gave patient a High Dose Flu shot. As he was walking in store he fell. This was about 3-4 min after the shot.
Age: 44.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Insomnia, Oedema peripheral
Clinical narrative: 1 day after vaccine given had redness and swelling at injection site an entire arm/fingers swollen; c/o insomnia past 2 nights.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Nasal congestion, Oropharyngeal pain
Clinical narrative: Approximately 48 hrs after receiving the flu shot patient developed sore throat which progressed to nasal congestion & cough.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Muscle spasms
Clinical narrative: Injection site reaction - small red bump baseball size hard area - sore to touch. Pt also complains of severe leg cramps during night since receiving & increased frequency of urination.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pollakiuria
Clinical narrative: Injection site reaction - small red bump baseball size hard area - sore to touch. Pt also complains of severe leg cramps during night since receiving & increased frequency of urination.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Rash erythematous
Clinical narrative: Patient called to let pharmacy know she had a red rash spreading from her injection site over onto her chest.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fungal infection, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced redness, soreness, & swelling at injection site. MD diagnosed as fungal infection due to needle.
Age: 18.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Pruritus, Rash generalised, Tenderness, Urticaria
Clinical narrative: Client returned to clinic on 12/6/12 at 2pm c/o hives and intense itching. Client noted to have 2 large areas to upper posterior arm. No heat present to palpation. Client stated spots were present upon waking this AM and are slightly painful to touch. Client also has rash appearing on bilat arms, waistline, back, and legs with tracks present.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Colour blindness acquired, Dyspnoea, Ear pain, Eye pain, Headache
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of parotid gland swelling in a 58-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included allergy to IVP dye, allergy to thimerosal and LIPITOR allergy. Concurrent medications included Tuberculin PPD. On 27 November 2012 at 13:30 the subject received unspecified dose of FLUARIX (.5 ml, unknown, right arm). On 29 November 2012, 2 days after vaccination with FLUARIX, the subject experienced parotid gland swelling, body pain, headache, stuffed sinuses and sore throat. On 30 November 2012, the subject experienced flashing in r eye, visual acuity decreased, loss of color vision, photosensitivity both eyes, blurred vision r eye, stabbing eye pain, tearing eyes and optic neuritis. The subject received FLUARIX on 27 November 2012 and he experienced body aches, headache, and parotid gland swelling on the morning of 29 November 2012. On 29 November 2012 his "maxillaries were packed and stuffed up" he also had a sore throat that extended to his Eustachian canals. On 30 November 2012 he experienced flashing in his right eye and decreased visual acuity and loss of color vision, with photosensitivity in both eyes. He experienced cloudy vision in the right eye "like looking through a cloud". He reported stabbing pain and tearing in both eyes, got worse on 01 December 2012, he went to the emergency department. He was admitted to the hospital on 01 December 2012 and discharged on 04 December 2012. The subject stated a physician (who was not the ophthalmologist) said he had optic neuritis secondary to the flu vaccination. He did see an ophthalmologist that said he could not diagnose neuritis and told him his retina was intact. The subject stated that all the symptoms continue. He was treated with IV steroid while in the hospital. The subject was hospitalised for 4 days and the healthcare professional considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the events of parotid gland swelling, body pain, headache, stuffed sinuses, sore throat, flashing in r eye, visual acuity decreased, loss of color vision, photosensitivity both eyes, blurred vision r eye and optic neuritis were unresolved; the stabbing eye pain and tearing eyes were worse. The healthcare professional considered the events of parotid gland swelling, body pain, headache, stuffed sinuses were probably related to vaccination with FLUARIX. The subject also reported that years ago on an unspecified date the he received unspecified dose of Influenza vaccine unspecified (unknown) and it had Thimerosal in it. He reported he experienced shortness of breath and was told he had an allergy to Thimerosal; he could not remember an additional information about this experience as it was so long ago.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Lacrimation increased, Optic neuritis, Oropharyngeal pain, Pain, Parotid gland enlargement
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of parotid gland swelling in a 58-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included allergy to IVP dye, allergy to thimerosal and LIPITOR allergy. Concurrent medications included Tuberculin PPD. On 27 November 2012 at 13:30 the subject received unspecified dose of FLUARIX (.5 ml, unknown, right arm). On 29 November 2012, 2 days after vaccination with FLUARIX, the subject experienced parotid gland swelling, body pain, headache, stuffed sinuses and sore throat. On 30 November 2012, the subject experienced flashing in r eye, visual acuity decreased, loss of color vision, photosensitivity both eyes, blurred vision r eye, stabbing eye pain, tearing eyes and optic neuritis. The subject received FLUARIX on 27 November 2012 and he experienced body aches, headache, and parotid gland swelling on the morning of 29 November 2012. On 29 November 2012 his "maxillaries were packed and stuffed up" he also had a sore throat that extended to his Eustachian canals. On 30 November 2012 he experienced flashing in his right eye and decreased visual acuity and loss of color vision, with photosensitivity in both eyes. He experienced cloudy vision in the right eye "like looking through a cloud". He reported stabbing pain and tearing in both eyes, got worse on 01 December 2012, he went to the emergency department. He was admitted to the hospital on 01 December 2012 and discharged on 04 December 2012. The subject stated a physician (who was not the ophthalmologist) said he had optic neuritis secondary to the flu vaccination. He did see an ophthalmologist that said he could not diagnose neuritis and told him his retina was intact. The subject stated that all the symptoms continue. He was treated with IV steroid while in the hospital. The subject was hospitalised for 4 days and the healthcare professional considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the events of parotid gland swelling, body pain, headache, stuffed sinuses, sore throat, flashing in r eye, visual acuity decreased, loss of color vision, photosensitivity both eyes, blurred vision r eye and optic neuritis were unresolved; the stabbing eye pain and tearing eyes were worse. The healthcare professional considered the events of parotid gland swelling, body pain, headache, stuffed sinuses were probably related to vaccination with FLUARIX. The subject also reported that years ago on an unspecified date the he received unspecified dose of Influenza vaccine unspecified (unknown) and it had Thimerosal in it. He reported he experienced shortness of breath and was told he had an allergy to Thimerosal; he could not remember an additional information about this experience as it was so long ago.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Photophobia, Photopsia, Photosensitivity reaction, Sinus congestion, Vision blurred
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of parotid gland swelling in a 58-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included allergy to IVP dye, allergy to thimerosal and LIPITOR allergy. Concurrent medications included Tuberculin PPD. On 27 November 2012 at 13:30 the subject received unspecified dose of FLUARIX (.5 ml, unknown, right arm). On 29 November 2012, 2 days after vaccination with FLUARIX, the subject experienced parotid gland swelling, body pain, headache, stuffed sinuses and sore throat. On 30 November 2012, the subject experienced flashing in r eye, visual acuity decreased, loss of color vision, photosensitivity both eyes, blurred vision r eye, stabbing eye pain, tearing eyes and optic neuritis. The subject received FLUARIX on 27 November 2012 and he experienced body aches, headache, and parotid gland swelling on the morning of 29 November 2012. On 29 November 2012 his "maxillaries were packed and stuffed up" he also had a sore throat that extended to his Eustachian canals. On 30 November 2012 he experienced flashing in his right eye and decreased visual acuity and loss of color vision, with photosensitivity in both eyes. He experienced cloudy vision in the right eye "like looking through a cloud". He reported stabbing pain and tearing in both eyes, got worse on 01 December 2012, he went to the emergency department. He was admitted to the hospital on 01 December 2012 and discharged on 04 December 2012. The subject stated a physician (who was not the ophthalmologist) said he had optic neuritis secondary to the flu vaccination. He did see an ophthalmologist that said he could not diagnose neuritis and told him his retina was intact. The subject stated that all the symptoms continue. He was treated with IV steroid while in the hospital. The subject was hospitalised for 4 days and the healthcare professional considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the events of parotid gland swelling, body pain, headache, stuffed sinuses, sore throat, flashing in r eye, visual acuity decreased, loss of color vision, photosensitivity both eyes, blurred vision r eye and optic neuritis were unresolved; the stabbing eye pain and tearing eyes were worse. The healthcare professional considered the events of parotid gland swelling, body pain, headache, stuffed sinuses were probably related to vaccination with FLUARIX. The subject also reported that years ago on an unspecified date the he received unspecified dose of Influenza vaccine unspecified (unknown) and it had Thimerosal in it. He reported he experienced shortness of breath and was told he had an allergy to Thimerosal; he could not remember an additional information about this experience as it was so long ago.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Visual acuity reduced
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of parotid gland swelling in a 58-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included allergy to IVP dye, allergy to thimerosal and LIPITOR allergy. Concurrent medications included Tuberculin PPD. On 27 November 2012 at 13:30 the subject received unspecified dose of FLUARIX (.5 ml, unknown, right arm). On 29 November 2012, 2 days after vaccination with FLUARIX, the subject experienced parotid gland swelling, body pain, headache, stuffed sinuses and sore throat. On 30 November 2012, the subject experienced flashing in r eye, visual acuity decreased, loss of color vision, photosensitivity both eyes, blurred vision r eye, stabbing eye pain, tearing eyes and optic neuritis. The subject received FLUARIX on 27 November 2012 and he experienced body aches, headache, and parotid gland swelling on the morning of 29 November 2012. On 29 November 2012 his "maxillaries were packed and stuffed up" he also had a sore throat that extended to his Eustachian canals. On 30 November 2012 he experienced flashing in his right eye and decreased visual acuity and loss of color vision, with photosensitivity in both eyes. He experienced cloudy vision in the right eye "like looking through a cloud". He reported stabbing pain and tearing in both eyes, got worse on 01 December 2012, he went to the emergency department. He was admitted to the hospital on 01 December 2012 and discharged on 04 December 2012. The subject stated a physician (who was not the ophthalmologist) said he had optic neuritis secondary to the flu vaccination. He did see an ophthalmologist that said he could not diagnose neuritis and told him his retina was intact. The subject stated that all the symptoms continue. He was treated with IV steroid while in the hospital. The subject was hospitalised for 4 days and the healthcare professional considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the events of parotid gland swelling, body pain, headache, stuffed sinuses, sore throat, flashing in r eye, visual acuity decreased, loss of color vision, photosensitivity both eyes, blurred vision r eye and optic neuritis were unresolved; the stabbing eye pain and tearing eyes were worse. The healthcare professional considered the events of parotid gland swelling, body pain, headache, stuffed sinuses were probably related to vaccination with FLUARIX. The subject also reported that years ago on an unspecified date the he received unspecified dose of Influenza vaccine unspecified (unknown) and it had Thimerosal in it. He reported he experienced shortness of breath and was told he had an allergy to Thimerosal; he could not remember an additional information about this experience as it was so long ago.
Age: 78.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: On 7-17-2012 patient received Tdap IM to left upper arm 0.5 cc. 11/27/2012 He returned to clinic for routine diabetes follow up and reported continuing pain at injection site limiting ROM.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Blood pressure decreased, Blood test normal, Decreased appetite
Clinical narrative: 9/14/12 -  Lost appetite - nauseous- without power to get out of bed & walk - visit Dr. and my blood pressure was under 90 - run blood test & everything was normal. 9/18/12 - Pain on all my extremities, cant' close my hands, hardly walk, inflammation on hands and feet - Dr. run more test and again was normal & refer me to another Dr. - he put me on naproxen. I feel better but pain in my hands & back remain.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Inflammation, Nausea, Pain in extremity
Clinical narrative: 9/14/12 -  Lost appetite - nauseous- without power to get out of bed & walk - visit Dr. and my blood pressure was under 90 - run blood test & everything was normal. 9/18/12 - Pain on all my extremities, cant' close my hands, hardly walk, inflammation on hands and feet - Dr. run more test and again was normal & refer me to another Dr. - he put me on naproxen. I feel better but pain in my hands & back remain.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Abdominal pain, Headache, Muscle twitching, Pyrexia
Clinical narrative: After Hep A, he experienced fever, abd pain, and now headache while standing & "twitching in the jaw and leg".
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, HEPA, MMR, VARCEL
Symptoms: Differential white blood cell count, Full blood count, Injection site rash, Petechiae, Rash generalised
Clinical narrative: Pt. in for imms. as below, gave imms pt became blotchy on (B)LE, trunk, face, neck, back (L)UE. Also produced petechial rash on neck and top of shoulder area. Pt was checked by Dr, given liquid oral BENADRYL 18 mL watched for about 40 min - rash dissipated pt went home with BENADRYL q 6 hrs.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, HEPA, MMR, VARCEL
Symptoms: Rash macular
Clinical narrative: Pt. in for imms. as below, gave imms pt became blotchy on (B)LE, trunk, face, neck, back (L)UE. Also produced petechial rash on neck and top of shoulder area. Pt was checked by Dr, given liquid oral BENADRYL 18 mL watched for about 40 min - rash dissipated pt went home with BENADRYL q 6 hrs.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site rash
Clinical narrative: Pt developed rash at injection site 1-2 days post-immunization. Sought medical attention and it was determined to be cellulitis. Pt prescribed antibiotics and recovered fully.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Arm swelling, redness, induration of (L) arm. Went to ER. Tx is antibiotic.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Confusional state, Dizziness, Fall, Feeling hot
Clinical narrative: Patient fainted after (2 minutes) shot. Fell backwards in waiting area, bumping buttocks 1st & back of head 2nd on floor. Pt. seemed confused at first, was pale & warm (per pt.) said he felt dizzy, looked to be weak & complained of visual disturbances. Placed pt. on back with feet elevated, gave water (cold) to sip. No loss of consciousness.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Head injury, Pallor, Syncope, Visual impairment
Clinical narrative: Patient fainted after (2 minutes) shot. Fell backwards in waiting area, bumping buttocks 1st & back of head 2nd on floor. Pt. seemed confused at first, was pale & warm (per pt.) said he felt dizzy, looked to be weak & complained of visual disturbances. Placed pt. on back with feet elevated, gave water (cold) to sip. No loss of consciousness.
Age: 18.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Body temperature increased, Chills, Erythema, Headache, Hyperhidrosis
Clinical narrative: MENVEO injection looked cloudy. (12-3) 3AM patient had fever/sweating/chills/headache. Temp at 9AM 102.4, gave alternating doses of APAP and Ibuprofen to get fever to 99.6 at 1045AM - continued through day. Patient also had headache, redness/swelling at FLUVIRIN site. Both arms sore. (12-4) Day 2 - night chills/sweats 2AM took 2 Xstr TYLENOL temp 8AM 101.1 alternated TYLENOL/Ibu all day general malaise. (12-4) Massive headache and sore neck, nausea, fever. Continued TYLENOL/Ibuprofen. Day 3 (12-5) temp normal, mild headache FLUVIRIN arm still red & sore feeling better though.
Age: 18.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Injection site erythema, Injection site swelling, Malaise, Nausea, Neck pain
Clinical narrative: MENVEO injection looked cloudy. (12-3) 3AM patient had fever/sweating/chills/headache. Temp at 9AM 102.4, gave alternating doses of APAP and Ibuprofen to get fever to 99.6 at 1045AM - continued through day. Patient also had headache, redness/swelling at FLUVIRIN site. Both arms sore. (12-4) Day 2 - night chills/sweats 2AM took 2 Xstr TYLENOL temp 8AM 101.1 alternated TYLENOL/Ibu all day general malaise. (12-4) Massive headache and sore neck, nausea, fever. Continued TYLENOL/Ibuprofen. Day 3 (12-5) temp normal, mild headache FLUVIRIN arm still red & sore feeling better though.
Age: 18.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Pain in extremity, Product colour issue, Pyrexia
Clinical narrative: MENVEO injection looked cloudy. (12-3) 3AM patient had fever/sweating/chills/headache. Temp at 9AM 102.4, gave alternating doses of APAP and Ibuprofen to get fever to 99.6 at 1045AM - continued through day. Patient also had headache, redness/swelling at FLUVIRIN site. Both arms sore. (12-4) Day 2 - night chills/sweats 2AM took 2 Xstr TYLENOL temp 8AM 101.1 alternated TYLENOL/Ibu all day general malaise. (12-4) Massive headache and sore neck, nausea, fever. Continued TYLENOL/Ibuprofen. Day 3 (12-5) temp normal, mild headache FLUVIRIN arm still red & sore feeling better though.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Erythema, Lymphadenopathy, Pain
Clinical narrative: Local pain and erythema (10 x 19 cm), positive axillary lymph enlargement, low grade temp 99.5.
Age: 0.81
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Small hive-like rash on both hands. Very slight rash on abd. No rash noted around inj. site.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13, RV5
Symptoms: Lethargy, Tremor
Clinical narrative: Mother called & stated patient was lethargic & shaking. Vaccines administered at 10AM & mother called at 130PM. Encouraged mother to have baby evaluated at an Emergency Room. 12-12-12 - Mother called patient is doing much better & they are planning on doing an MRI.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Haemorrhage, Injection site erythema, Injection site reaction, Injection site swelling, Nodule
Clinical narrative: Knot in arm, bleeding, severe redness and swelling around area shot was given, and down arm. Arm felt hot, and tingling felt from shot area down to wrist and fingers.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Skin warm
Clinical narrative: Knot in arm, bleeding, severe redness and swelling around area shot was given, and down arm. Arm felt hot, and tingling felt from shot area down to wrist and fingers.
Age: 45.0
Sex: F
Vaccine: YF
Symptoms: Dyspnoea, Injection site erythema, Injection site pruritus, Injection site swelling, Paraesthesia
Clinical narrative: REDNESS, SWELLING AND ITCHING TO LOCATION OF VACCINE; SHORTNESS OF BREATH AND TINGLING DOWN LEFT ARM.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Erythema, Injection site erythema, Skin warm
Clinical narrative: Varying degrees of redness on left shoulder (same arm as shot administration). States feels bruised, warm to touch, denies itching.  In shot area of left deltoid pt has redness in shape of the bandaid.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Angiotensin converting enzyme increased, Back pain, Blood folate normal, Blood immunoglobulin A normal
Clinical narrative: Received HPV#3 in August 29, 2012 and on Sept 1, 2012 developed progressive bilateral leg and then back pain without clear etiology for ~6 weeks and then developed progressive leg weakness and then some upper extremity weakness over subsequent ~6 weeks. Her weakness was such that she was unable to walk. Hospitalized on 12/4 with trace reflexes by neurologist and significant leg>arm weakness. Clinical history, exam, EMG and LP all consistent with atyical Guillain-Barre of axonal variation. She received 5 days of IVIG and improved and was able to ambulate though not completely back to normal prior to discharge. Also, at admission she had fever and URI symptoms without meningismus for 1-2 days, was PCR positive for influenza B and improved within 2 days on tamiflu. No history of symptoms suggestive of lyme. Other vaccines received in 2012--HPV#1 Feb 9, 2012, HPV#2 Apr 27, 2012, Tdap 6/21/2012. Family reports no problems after any of these vaccines.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Blood thyroid stimulating hormone normal, Borrelia test positive, C-reactive protein normal, CSF culture negative, CSF glucose decreased
Clinical narrative: Received HPV#3 in August 29, 2012 and on Sept 1, 2012 developed progressive bilateral leg and then back pain without clear etiology for ~6 weeks and then developed progressive leg weakness and then some upper extremity weakness over subsequent ~6 weeks. Her weakness was such that she was unable to walk. Hospitalized on 12/4 with trace reflexes by neurologist and significant leg>arm weakness. Clinical history, exam, EMG and LP all consistent with atyical Guillain-Barre of axonal variation. She received 5 days of IVIG and improved and was able to ambulate though not completely back to normal prior to discharge. Also, at admission she had fever and URI symptoms without meningismus for 1-2 days, was PCR positive for influenza B and improved within 2 days on tamiflu. No history of symptoms suggestive of lyme. Other vaccines received in 2012--HPV#1 Feb 9, 2012, HPV#2 Apr 27, 2012, Tdap 6/21/2012. Family reports no problems after any of these vaccines.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: CSF monocyte count increased, CSF protein increased, CSF white blood cell count increased, Electromyogram abnormal, Guillain-Barre syndrome
Clinical narrative: Received HPV#3 in August 29, 2012 and on Sept 1, 2012 developed progressive bilateral leg and then back pain without clear etiology for ~6 weeks and then developed progressive leg weakness and then some upper extremity weakness over subsequent ~6 weeks. Her weakness was such that she was unable to walk. Hospitalized on 12/4 with trace reflexes by neurologist and significant leg>arm weakness. Clinical history, exam, EMG and LP all consistent with atyical Guillain-Barre of axonal variation. She received 5 days of IVIG and improved and was able to ambulate though not completely back to normal prior to discharge. Also, at admission she had fever and URI symptoms without meningismus for 1-2 days, was PCR positive for influenza B and improved within 2 days on tamiflu. No history of symptoms suggestive of lyme. Other vaccines received in 2012--HPV#1 Feb 9, 2012, HPV#2 Apr 27, 2012, Tdap 6/21/2012. Family reports no problems after any of these vaccines.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Hyporeflexia, Immunoglobulin therapy, Influenza B virus test positive, Muscular weakness, Nuclear magnetic resonance imaging spinal cord abnormal
Clinical narrative: Received HPV#3 in August 29, 2012 and on Sept 1, 2012 developed progressive bilateral leg and then back pain without clear etiology for ~6 weeks and then developed progressive leg weakness and then some upper extremity weakness over subsequent ~6 weeks. Her weakness was such that she was unable to walk. Hospitalized on 12/4 with trace reflexes by neurologist and significant leg>arm weakness. Clinical history, exam, EMG and LP all consistent with atyical Guillain-Barre of axonal variation. She received 5 days of IVIG and improved and was able to ambulate though not completely back to normal prior to discharge. Also, at admission she had fever and URI symptoms without meningismus for 1-2 days, was PCR positive for influenza B and improved within 2 days on tamiflu. No history of symptoms suggestive of lyme. Other vaccines received in 2012--HPV#1 Feb 9, 2012, HPV#2 Apr 27, 2012, Tdap 6/21/2012. Family reports no problems after any of these vaccines.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Polymerase chain reaction, Polyneuropathy, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: Received HPV#3 in August 29, 2012 and on Sept 1, 2012 developed progressive bilateral leg and then back pain without clear etiology for ~6 weeks and then developed progressive leg weakness and then some upper extremity weakness over subsequent ~6 weeks. Her weakness was such that she was unable to walk. Hospitalized on 12/4 with trace reflexes by neurologist and significant leg>arm weakness. Clinical history, exam, EMG and LP all consistent with atyical Guillain-Barre of axonal variation. She received 5 days of IVIG and improved and was able to ambulate though not completely back to normal prior to discharge. Also, at admission she had fever and URI symptoms without meningismus for 1-2 days, was PCR positive for influenza B and improved within 2 days on tamiflu. No history of symptoms suggestive of lyme. Other vaccines received in 2012--HPV#1 Feb 9, 2012, HPV#2 Apr 27, 2012, Tdap 6/21/2012. Family reports no problems after any of these vaccines.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Upper respiratory tract infection, Vitamin B12 normal
Clinical narrative: Received HPV#3 in August 29, 2012 and on Sept 1, 2012 developed progressive bilateral leg and then back pain without clear etiology for ~6 weeks and then developed progressive leg weakness and then some upper extremity weakness over subsequent ~6 weeks. Her weakness was such that she was unable to walk. Hospitalized on 12/4 with trace reflexes by neurologist and significant leg>arm weakness. Clinical history, exam, EMG and LP all consistent with atyical Guillain-Barre of axonal variation. She received 5 days of IVIG and improved and was able to ambulate though not completely back to normal prior to discharge. Also, at admission she had fever and URI symptoms without meningismus for 1-2 days, was PCR positive for influenza B and improved within 2 days on tamiflu. No history of symptoms suggestive of lyme. Other vaccines received in 2012--HPV#1 Feb 9, 2012, HPV#2 Apr 27, 2012, Tdap 6/21/2012. Family reports no problems after any of these vaccines.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Fatigue, Pyrexia
Clinical narrative: Fatigue, Dizziness, Chills followed by fever of 100.9 degrees F.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient was screened given Afluria appropriate dose into Left Deltoid. Next day patient complained to HR person at his work that his arm was hurting and he said it was about the time he had his shot.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Injection site pain, Pyrexia
Clinical narrative: Soreness to arm at site of injection, fever, weakness. Symptoms resolved after a day.
Age: 1.27
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Conjunctivitis infective, Pyrexia, Rash, Rash erythematous, Rash macular
Clinical narrative: Pink eye - onset 12/06/2012 still present today (12/12/2012) Right eye Fever - (around 100 degrees) - onset 12/06/2012 ending 12/09/2012 Tylenol administered until fever broke. Rash - onset 12/09/2012 still present today (12/12/2012) Red bumps, mainly on the right side of face and some on left side of face. "Blotchy" on face as well.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Hypersensitivity, Rhinorrhoea, Sneezing
Clinical narrative: Running nose, sneezing. Left eye swollen shut, all as if an allergic reaction. I took a Claritin tablet.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dysaesthesia, Hypergammaglobulinaemia benign monoclonal
Clinical narrative: After receiving shingles vaccination developed prolonged burning sensation throughout body - genitals-extremities for 2 months. Diagnosed with dysesthesia and monoclonal gammopathy of undetermined significance.
Age: 36.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness at injection site (flu shot, right arm) itchy.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Dysphagia, Pain, Pyrexia
Clinical narrative: Difficulty swallowing (getting worse over 1 hour), diarrhea (8 pm), chills (8:15 pm), fever (9 pm),  aches (9:30 pm).  After 10 hours, back to normal.
Age: 13.0
Sex: M
Vaccine: FLUN3, HEPA, HPV4
Symptoms: Cough, Dyspnoea, Status asthmaticus, Tachypnoea, Wheezing
Clinical narrative: At night on th day of the vaccination (12/10/12) the patient had increased coughing. On 12/11/12 the patient had acute shortness of breath. She went to the ED where she had tachypnea, and wheezing. She reeived epinephrine, albuterol 5mg + ATROVENT and SOLU-MEDROL. The patient went into status asthmaticus and required continuous albuterol 15mg/hr for 7 hours.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: The primary reporter for this case is the field representative. The representative indicated the doctor stated that patient was administered ZOSTAVAX and the flu vaccine in the same arm on the same day. The representative indicated the doctor stated the patient had a red swelling at the injection site and fever. No further information is available.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen, red, left deltoid.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Patient woke up on 12/12/12 with a fever. At 9am temp was 101.8 degrees F, around 12:15pm it was 102.5 degrees. Also feels really tired and entire body hurts. Patient instructed to take NSAIDS for 24 hours and call back if no improvement or it worsens.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 26 years old female patient with no drug reactions/ allergies and no pertinent medical history who on 29-NOV-2012, was vaccinated with a dose of GARDASIL (IM(dose not reported) (lot # 672193/1524AA, Exp: 24-AUG-2014). No other co-suspects were reported. There was no concomitant medications. The nurse reported that the patient developed severe headaches with fever and slight dizziness 5 hours after getting a dose of GARDASIL. No treatment was given for the events. The outcome of the events was reported as recovered/resolved on 30-NOV-2012. No laboratory diagnostic studies were performed. The patient sought medical attention via calling the nurse practitioner. The relatedness for the events was unknown for GARDASIL. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical nurse refers to 8 patients of unknown age and gender. On 02-OCT-2012, the patients were vaccinated with GARDASIL (lot # 0420AE and expiry date was 02-NOV-2014, route and dose were not reported) that was exposed to 25 degree Fahrenheit for an unknown period of time. No concomitant medications were reported. No adverse symptoms reported. This is one of the several reports received from the same reporter (MARRS# 1212USA000914, 1212USA003709, 1212USA003710, 1212USA003711, 1212USA003712, 1212USA003713, 1212USA003714 and 1212USA004285) Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Skin reaction, Tenderness, Testicular swelling
Clinical narrative: Pt received ZOSTAVAX shot 12/7/12. Had a little pain around site. Arm hurt when trying to sleep. In morning had 2 to 3" of swelling. Area red and tender. Pt notified pharmacy 12/09/12. As of 12/12, have not heard back.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: Diarrhea x 4 days starting evening of shot (12/8) symptoms resolved by 12/12/12.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Erythema, Fatigue, Influenza like illness, Swelling
Clinical narrative: Redness, swelling for 1-2 hours after vaccination. Swelling 8 inches x 4 inches 24 hours later. Flu-like symptoms, chills, tired, no fever.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: 8 x 9 cm raised red itchy wheal.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Generalized hives 2 hours after vaccination for Flu. Itchy. Patient taken to medical center ED. Patient given BENADRYL, prednisone and famotidine. Pt improved after treatment. Parents advised to continue treatment for 3-4 days.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, RV1
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Rt. arm sore when lift up.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Immediate post-injection reaction, Pruritus, Rash
Clinical narrative: Patient reported that his left arm began to hurt immediately following the injection and that this pain increased over time. On exam the day following the injection the patient was noted to have a softball sized red welt with a raised red ring around it. Patient had a temp of 100.3 at this time. No itching at the site. Patient was prescribed BENADRYL and triamcinolone topical ointment. Symptoms: SkinRash, Rash & UrticariaPruritus. Treatment: Diphenhydramine, Triamcinolone.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Patient reported that his left arm began to hurt immediately following the injection and that this pain increased over time. On exam the day following the injection the patient was noted to have a softball sized red welt with a raised red ring around it. Patient had a temp of 100.3 at this time. No itching at the site. Patient was prescribed BENADRYL and triamcinolone topical ointment. Symptoms: SkinRash, Rash & UrticariaPruritus. Treatment: Diphenhydramine, Triamcinolone.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Musculoskeletal discomfort
Clinical narrative: Pt got pneumonia shot yesterday and today she is unable to use her left arm. She called the orthopedic doctor. Was told she take 2 CELEBREX tablets and use ice. And the feeling should return to arm in about one week. Apparently she got the shot too high up on her arm which caused this reaction. Pt wants to know if you would have any other instructions for her.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. The primary reporter for this case is the parent who stated the both her children had not received the complete scheduled series of GARDASIL. One child received one dose (unspecified which dose in the series) and the second child received two doses (unspecified which doses in the series). No adverse experiences reported. All AE fields apply to both patients. Some AE fields are NA due to the caller not wanting to answer AE questions. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. The outcome of not received the complete schedule series of GARDASIL is unknown. The relatedness for not received the complete schedule series of GARDASIL is unknown for GARDASIL. No further AE information was provided.