chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Abscess, Activities of daily living impaired, Antibody test normal, Back pain, Bacterial test negative
Clinical narrative: Day 1 L arm ache, fever/chills, nausea. Day 2 Fever/chills, body aches.  Day 3 L arm lymph node swollen/tender, pain begins to radiate throughout back. Day 4 fever/chills Pain continues to radiate throughout body. Day 5 fever/ chills worsening. Extreme pain in back L arm, neck/head and starting to radiate down legs. Day 6 fever/chills continuing with pain.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Blood culture negative, Chills, Coombs test negative, Dehydration, Dizziness
Clinical narrative: Day 1 L arm ache, fever/chills, nausea. Day 2 Fever/chills, body aches.  Day 3 L arm lymph node swollen/tender, pain begins to radiate throughout back. Day 4 fever/chills Pain continues to radiate throughout body. Day 5 fever/ chills worsening. Extreme pain in back L arm, neck/head and starting to radiate down legs. Day 6 fever/chills continuing with pain.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Dizziness postural, Drug hypersensitivity, Dysphagia, Dyspnoea, Full blood count normal
Clinical narrative: Day 1 L arm ache, fever/chills, nausea. Day 2 Fever/chills, body aches.  Day 3 L arm lymph node swollen/tender, pain begins to radiate throughout back. Day 4 fever/chills Pain continues to radiate throughout body. Day 5 fever/ chills worsening. Extreme pain in back L arm, neck/head and starting to radiate down legs. Day 6 fever/chills continuing with pain.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Lymphadenopathy, Metabolic function test normal, Mononucleosis heterophile test negative, Nausea, Oropharyngeal pain
Clinical narrative: Day 1 L arm ache, fever/chills, nausea. Day 2 Fever/chills, body aches.  Day 3 L arm lymph node swollen/tender, pain begins to radiate throughout back. Day 4 fever/chills Pain continues to radiate throughout body. Day 5 fever/ chills worsening. Extreme pain in back L arm, neck/head and starting to radiate down legs. Day 6 fever/chills continuing with pain.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Pain, Pain in extremity, Pharyngeal oedema, Pyrexia, Streptococcus test negative
Clinical narrative: Day 1 L arm ache, fever/chills, nausea. Day 2 Fever/chills, body aches.  Day 3 L arm lymph node swollen/tender, pain begins to radiate throughout back. Day 4 fever/chills Pain continues to radiate throughout body. Day 5 fever/ chills worsening. Extreme pain in back L arm, neck/head and starting to radiate down legs. Day 6 fever/chills continuing with pain.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Throat irritation, Tremor
Clinical narrative: Day 1 L arm ache, fever/chills, nausea. Day 2 Fever/chills, body aches.  Day 3 L arm lymph node swollen/tender, pain begins to radiate throughout back. Day 4 fever/chills Pain continues to radiate throughout body. Day 5 fever/ chills worsening. Extreme pain in back L arm, neck/head and starting to radiate down legs. Day 6 fever/chills continuing with pain.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Vertigo.
Age: 1.42
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Viral test positive
Clinical narrative: Fever of 102 and rash.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe shoulder pain. Can't raise arm above head. This has been going on for four months now.
Age: 20.0
Sex: M
Vaccine: FLU3, HEPAB, TYP
Symptoms: Dizziness, Hot flush, Vomiting
Clinical narrative: Vomiting, hot flashes dizziness.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Nausea, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: TDAP vaccine received on 2/1/12, 2/2/12 evening (Rt) arm sore, underneath sore. 2/3/12 - 2/4/12 (Rt) arm swollen painful, lymph node swollen under (Rt) axilla. Took ADVIL q 4-6 hours. 2/4/11 - aching ax over nausea & swelling decrease.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Crying, Injection site swelling
Clinical narrative: Mom reports intense crying for 24 hrs and swelling at site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: MARKED WARMTH/EDEMA MID-WAY TO BACK OF LEFT LEG. MILD PINK ERYTHEMA DIFFUSELY OVER ENTIRE LEFT ANTERIOR THIGH. FULL ROM OF LEFT HIP.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Facial paresis, VIIth nerve paralysis
Clinical narrative: Awoke 2/3/11 with sudden-onset Left-sided facial weakness/paralysis.  Diagnosed by her personal physician on 2/3/11 with Bell's Palsy; treated by her PMD with Prednisone 20mg PO BID x6 days.  Individual is on day 4 of treatment, and is still currently having symptoms.
Age: 1.01
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: 20 vesicular lesions on arms.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Patient had area of blotchy redness, pain, and sensation of heat on skin. This area was about 5 inches in diameter on the upper arm at the location of the injection.
Age: 0.34
Sex: M
Vaccine: DTAP, RV1
Symptoms: Blood test abnormal, Dehydration, Diarrhoea, Vomiting projectile
Clinical narrative: After projectile vomiting for 4 days coupled with diarrhea, patient taken to ER for dehydration concern where he was given anti-nausea pills and sent home. Vomiting stopped with this, but with diarrhea continuing for another week, patient was taken to Pediatrician where blood work was done showing levels were off. Admitted to hospital overnight for IV fluids and monitoring.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Granuloma annulare, Immune system disorder, Rash generalised
Clinical narrative: Large round circles on inner thighs, rash all over front of both thighs down to knees. Has continued to spread for over 4 months, back of legs, arms, elbows, back of neck, around waist, ribcage, underarms. Diagnosed by Dermatologist and hospital by 3 separate biopsies as Granuloma Annulare. Immune system reaction.
Age: 44.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Patient given 2 vaccines in different arms, rxn was swelling/redness dx as "severe rxn to vaccinations". Pt fully recovered.
Age: 0.54
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Injection site erythema
Clinical narrative: Legs became very red. Cold compresses given in office. 435pm Dad said legs still a little red, but seemed fine.
Age: 48.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Chills, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: On 11/9/2011 pt got Tdap & Flu shot & pt had pain & redness around site of tetanus shot. Pt got fever & chills the night of the shots which lasted 2 days & Tdap left arm redness lasted 1 wk & pt with residual pain with decreased function at left arm site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Presented to office with 2 1/2 in x 2 in erythema raised lesion at the injection site Rt leg, warm to touch. Ice pack/compress every 4 hrs KEFLEX prescribed for early cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Skin lesion
Clinical narrative: Presented to office with 2 1/2 in x 2 in erythema raised lesion at the injection site Rt leg, warm to touch. Ice pack/compress every 4 hrs KEFLEX prescribed for early cellulitis.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pain in extremity, Tenderness, Urticaria
Clinical narrative: Patient woke up with pain radiating from left arm and chills. Next morning, pt. noticed 6 welts about the size of a quarter on her arm which were painful to touch. Welts resolved completely in 4 days after taking BENADRYL.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Pt. received ZOSTAVAX injection on 2/4/12. Pt. presented to pharmacy on 2/6/12 with 5" cellulitis at injection site (red & hot) - Tx included MEDROL dose pack and ZYRTEC 10mg PO QD.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient called immunizing pharmacist on 2/6/12 to report rash/hot/swollen reaction at injection site. Reaction was noted on 2/4/12 and still evident at time of phone call. Injection site: Deltoid/Rt. arm.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Rash generalised
Clinical narrative: 2 wks post vaccine disseminated rash on body.
Age: 9.0
Sex: F
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: CSF test, Guillain-Barre syndrome, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Guillain Barre onset symptom 1/23.
Age: 9.0
Sex: F
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre onset symptom 1/23.
Age: 9.0
Sex: F
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Guillain Barre onset symptom 1/23.
Age: 13.0
Sex: F
Vaccine: MMR, MMRV, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None as of 1/23/12.
Age: 78.0
Sex: M
Vaccine: YF
Symptoms: Abdominal pain, Bacterial diarrhoea, Diarrhoea, Fatigue, Flavivirus test positive
Clinical narrative: - Fever 38.1 C (5 - 7 days, diarrhea, abdominal pain, lassitude, profound malaise, hypotensive,  - supportive treatment - short course antibiotic therapy for bacterial diarrhea.
Age: 78.0
Sex: M
Vaccine: YF
Symptoms: Hypotension, Malaise, Polymerase chain reaction, Pyrexia, Stool analysis normal
Clinical narrative: - Fever 38.1 C (5 - 7 days, diarrhea, abdominal pain, lassitude, profound malaise, hypotensive,  - supportive treatment - short course antibiotic therapy for bacterial diarrhea.
Age: 78.0
Sex: M
Vaccine: YF
Symptoms: Viral test positive, White blood cell count increased
Clinical narrative: - Fever 38.1 C (5 - 7 days, diarrhea, abdominal pain, lassitude, profound malaise, hypotensive,  - supportive treatment - short course antibiotic therapy for bacterial diarrhea.
Age: 32.0
Sex: M
Vaccine: ANTH, FLU3, HEPA, SMALL, TYP, ANTH, FLU3, HEPA, SMALL, TYP
Symptoms: Injection site discharge, Injection site erythema, Injection site scab, Rash erythematous, Rash generalised
Clinical narrative: Patient received SPV (3), AVA (1), Hep A (2), Flu (TIV) and typhoid vaccines on 31 Oct. Patient received SPV in his L) upper arm. He reports receiving 2 previous SPV during childhood. Reports taking precautions to prevent autoinoculation and contact transmission. Has been changing SPV site dressing after showering and reports normal site progression. Patient denies any fever, chills, myalgias, arthralgias, or headaches during the first week post-vaccination. Also, denies any flushing, dyspnea, wheezing, facial swelling, itching or swelling of tongue, mouth or throat, or GI-related symptoms following vaccine receipt. Patient first noted itchy rash on his neck 2 days ago (7 days post-vaccination, 7 Nov) which spread to his chest and then "all over". Denies any lesions in his mouth or on his palms or soles. Describes as red bumps. No drainage from lesions. No scaling or peeling. Denies history of any similar rashes in the past. Denies any chronic skin conditions such as eczema, psoriasis, acne, etc. Denies allergies to medications, foods, latex or stings/bites. Only complaint today is itching. No chest pain, shortness of breath, or palpitations. Exam: Alert. In no acute distress. Not ill-appearing. Oral cavity: no lesions seen in mouth. Lungs CTA. No adventitious sounds were present. Heart Rate and Rhythm: Normal. Heart Sounds: Normal. Murmurs: No murmurs were heard. Skin: More than 15 skin lesions primarily maculopapular lesions on face, neck, trunk, chest, arms, thighs (reported, not examined), very few lesions below knees. No lesions on hands or feet. Normal except as noted. Assessment of Injection Site: showed no abnormalities Smallpox vaccination site on L) upper arm examined - scabbing with minimal drainage; minimal erythema surrounding area; no satellite lesions. No edema. At follow up visit on 14 Nov rash on face and neck markedly improved; new lesions on lower extremities (some appearing ecchymotic). No systemic symptoms. Photos and clinical notes from 9 and 14 Nov will be sent with VAERS report.
Age: 32.0
Sex: M
Vaccine: ANTH, FLU3, HEPA, SMALL, TYP, ANTH, FLU3, HEPA, SMALL, TYP
Symptoms: Rash maculo-papular, Rash pruritic, Skin lesion
Clinical narrative: Patient received SPV (3), AVA (1), Hep A (2), Flu (TIV) and typhoid vaccines on 31 Oct. Patient received SPV in his L) upper arm. He reports receiving 2 previous SPV during childhood. Reports taking precautions to prevent autoinoculation and contact transmission. Has been changing SPV site dressing after showering and reports normal site progression. Patient denies any fever, chills, myalgias, arthralgias, or headaches during the first week post-vaccination. Also, denies any flushing, dyspnea, wheezing, facial swelling, itching or swelling of tongue, mouth or throat, or GI-related symptoms following vaccine receipt. Patient first noted itchy rash on his neck 2 days ago (7 days post-vaccination, 7 Nov) which spread to his chest and then "all over". Denies any lesions in his mouth or on his palms or soles. Describes as red bumps. No drainage from lesions. No scaling or peeling. Denies history of any similar rashes in the past. Denies any chronic skin conditions such as eczema, psoriasis, acne, etc. Denies allergies to medications, foods, latex or stings/bites. Only complaint today is itching. No chest pain, shortness of breath, or palpitations. Exam: Alert. In no acute distress. Not ill-appearing. Oral cavity: no lesions seen in mouth. Lungs CTA. No adventitious sounds were present. Heart Rate and Rhythm: Normal. Heart Sounds: Normal. Murmurs: No murmurs were heard. Skin: More than 15 skin lesions primarily maculopapular lesions on face, neck, trunk, chest, arms, thighs (reported, not examined), very few lesions below knees. No lesions on hands or feet. Normal except as noted. Assessment of Injection Site: showed no abnormalities Smallpox vaccination site on L) upper arm examined - scabbing with minimal drainage; minimal erythema surrounding area; no satellite lesions. No edema. At follow up visit on 14 Nov rash on face and neck markedly improved; new lesions on lower extremities (some appearing ecchymotic). No systemic symptoms. Photos and clinical notes from 9 and 14 Nov will be sent with VAERS report.
Age: 32.0
Sex: M
Vaccine: ANTH, FLU3, HEPA, SMALL, TYP, ANTH, FLU3, HEPA, SMALL, TYP
Symptoms: Ecchymosis, Immune complex assay, Rash erythematous, Rash generalised, Rash maculo-papular
Clinical narrative: Patient received SPV (3), AVA (1), Hep A (2), Flu (TIV) and typhoid vaccines on 31 Oct. Patient received SPV in his L) upper arm. He reports receiving 2 previous SPV during childhood. Reports taking precautions to prevent autoinoculation and contact transmission. Has been changing SPV site dressing after showering and reports normal site progression. Patient denies any fever, chills, myalgias, arthralgias, or headaches during the first week post-vaccination. Also, denies any flushing, dyspnea, wheezing, facial swelling, itching or swelling of tongue, mouth or throat, or GI-related symptoms following vaccine receipt. Patient first noted itchy rash on his neck 2 days ago (7 days post-vaccination, 7 Nov) which spread to his chest and then "all over". Denies any lesions in his mouth or on his palms or soles. Describes as red bumps. No drainage from lesions. No scaling or peeling. Denies history of any similar rashes in the past. Denies any chronic skin conditions such as eczema, psoriasis, acne, etc. Denies allergies to medications, foods, latex or stings/bites. Only complaint today is itching. No chest pain, shortness of breath, or palpitations. Exam: Alert. In no acute distress. Not ill-appearing. Oral cavity: no lesions seen in mouth. Lungs CTA. No adventitious sounds were present. Heart Rate and Rhythm: Normal. Heart Sounds: Normal. Murmurs: No murmurs were heard. Skin: More than 15 skin lesions primarily maculopapular lesions on face, neck, trunk, chest, arms, thighs (reported, not examined), very few lesions below knees. No lesions on hands or feet. Normal except as noted. Assessment of Injection Site: showed no abnormalities Smallpox vaccination site on L) upper arm examined - scabbing with minimal drainage; minimal erythema surrounding area; no satellite lesions. No edema. At follow up visit on 14 Nov rash on face and neck markedly improved; new lesions on lower extremities (some appearing ecchymotic). No systemic symptoms. Photos and clinical notes from 9 and 14 Nov will be sent with VAERS report.
Age: 32.0
Sex: M
Vaccine: ANTH, FLU3, HEPA, SMALL, TYP, ANTH, FLU3, HEPA, SMALL, TYP
Symptoms: Rash pruritic, Skin lesion, Vaccination site discharge, Vaccination site erythema, Vaccination site scab
Clinical narrative: Patient received SPV (3), AVA (1), Hep A (2), Flu (TIV) and typhoid vaccines on 31 Oct. Patient received SPV in his L) upper arm. He reports receiving 2 previous SPV during childhood. Reports taking precautions to prevent autoinoculation and contact transmission. Has been changing SPV site dressing after showering and reports normal site progression. Patient denies any fever, chills, myalgias, arthralgias, or headaches during the first week post-vaccination. Also, denies any flushing, dyspnea, wheezing, facial swelling, itching or swelling of tongue, mouth or throat, or GI-related symptoms following vaccine receipt. Patient first noted itchy rash on his neck 2 days ago (7 days post-vaccination, 7 Nov) which spread to his chest and then "all over". Denies any lesions in his mouth or on his palms or soles. Describes as red bumps. No drainage from lesions. No scaling or peeling. Denies history of any similar rashes in the past. Denies any chronic skin conditions such as eczema, psoriasis, acne, etc. Denies allergies to medications, foods, latex or stings/bites. Only complaint today is itching. No chest pain, shortness of breath, or palpitations. Exam: Alert. In no acute distress. Not ill-appearing. Oral cavity: no lesions seen in mouth. Lungs CTA. No adventitious sounds were present. Heart Rate and Rhythm: Normal. Heart Sounds: Normal. Murmurs: No murmurs were heard. Skin: More than 15 skin lesions primarily maculopapular lesions on face, neck, trunk, chest, arms, thighs (reported, not examined), very few lesions below knees. No lesions on hands or feet. Normal except as noted. Assessment of Injection Site: showed no abnormalities Smallpox vaccination site on L) upper arm examined - scabbing with minimal drainage; minimal erythema surrounding area; no satellite lesions. No edema. At follow up visit on 14 Nov rash on face and neck markedly improved; new lesions on lower extremities (some appearing ecchymotic). No systemic symptoms. Photos and clinical notes from 9 and 14 Nov will be sent with VAERS report.
Age: 71.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Oedema peripheral
Clinical narrative: A 71-year-old female received a tetanus and diphtheria toxoid adsorbed vaccine 8 years prior during an emergency room visit. The patient experienced a red and swollen arm after receiving the vaccine and at the time of the event the patient was advised to treat using massage. Patient had recovered. This event was reported to MBL's distributor, Merck, by a pharmacist. The pharmacist had obtained the information as part of the patient's health history. Patient's primary doctor was contacted; he had no further information regarding the event. MBL is not able to obtain any further follow-up information.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Incorrect route of drug administration, Injection site discolouration, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Administration error. A 47-year-old female received a Td vaccine intradermally instead of a PPD, on 10/10/11. The day after the vaccination, the patient experienced discomfort, erythema (2.0 cm), induration and tenderness at the injection site. The patient returned to the doctor's office on 10/11/11. Follow up obtained on 10/18/11: The doctor's office had contacted the patient by phone. The patient reported that the erythema and tenderness had worsened on the 4th day after the injection, but had since started to improve. Follow up obtained on 11/1/11: The patient was contacted by the doctor's office and had stated that she still feels a little nodule under the skin at the injection site. Follow up obtained on 11/17/11: Patient went to the doctor's office for a visit on 11/10/11. The reaction on the patient's arm was still visible. The clinic staff contacted the patient on 11/17/11. Patient had stated that the reaction was 90% better, not tender, and the nodule was going down, but there is still some discoloration. Follow up obtained on 12/6/11: Patient went to the doctor's office for a visit on 12/6/11. The reaction was 95% better, but still detectable, and the reaction site was slightly raised.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Administration error. A 47-year-old female received a Td vaccine intradermally instead of a PPD, on 10/10/11. The day after the vaccination, the patient experienced discomfort, erythema (2.0 cm), induration and tenderness at the injection site. The patient returned to the doctor's office on 10/11/11. Follow up obtained on 10/18/11: The doctor's office had contacted the patient by phone. The patient reported that the erythema and tenderness had worsened on the 4th day after the injection, but had since started to improve. Follow up obtained on 11/1/11: The patient was contacted by the doctor's office and had stated that she still feels a little nodule under the skin at the injection site. Follow up obtained on 11/17/11: Patient went to the doctor's office for a visit on 11/10/11. The reaction on the patient's arm was still visible. The clinic staff contacted the patient on 11/17/11. Patient had stated that the reaction was 90% better, not tender, and the nodule was going down, but there is still some discoloration. Follow up obtained on 12/6/11: Patient went to the doctor's office for a visit on 12/6/11. The reaction was 95% better, but still detectable, and the reaction site was slightly raised.
Age: 33.0
Sex: F
Vaccine: MMR, TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: A 33-year-old female Td, TB skin test and MMR on 11/28/11. On 11/29/11, the patient noticed a large red welt at the injection site for the Td vaccine (left deltoid); the patient also reported warmth, induration and some soreness with occasional shooting pain. The patient went to the medical office on 11/30/11; no treatment was given. The patient returned to the medical office on 12/6/11. Patient has recovered.
Age: 33.0
Sex: F
Vaccine: MMR, TD
Symptoms: Pain, Urticaria
Clinical narrative: A 33-year-old female Td, TB skin test and MMR on 11/28/11. On 11/29/11, the patient noticed a large red welt at the injection site for the Td vaccine (left deltoid); the patient also reported warmth, induration and some soreness with occasional shooting pain. The patient went to the medical office on 11/30/11; no treatment was given. The patient returned to the medical office on 12/6/11. Patient has recovered.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Malaise, Rash
Clinical narrative: A 61-year-old female received a Td vaccine 04/30/1. In November 2011, during a routine health screen at a pharmacy, the patient reported to the pharmacist that she experienced a rash at her jaw line and on her chest after receiving a Td vaccine. The patient had recovered from the rash, but indicated that she has not felt healthy since. MBL is not able to obtain additional information regarding the patient's status.
Age: 1.0
Sex: F
Vaccine: MEA
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Information has been received from a consumer concerning her daughter, an approximately 12 month old female who in 2008 was vaccinated with ATTENUVAX. The consumer reported that her daughter received ATTENUVAX in 2008 and developed a rash in 2008. The patient was brought to physician. At the time of report, the patient's outcome was unknown. The patient also developed the chicken pox while received chicken pox vaccine (1108USA00001). No further information is available.
Age: 0.9
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Death
Clinical narrative: Initial report received from a health care professional on 01 February 2012. An 11-month-old infant, with medical history not reported, received an injection (route and site not reported) of INFLUENZA VACCINE, sanofi pasteur Inc. lot number not reported, on 25 January 2012. The patient passed away on 27 January 2012 with no known cause. No further information was provided. The outcome was reported as fatal. Documents held by sender: None.
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Pt developed neuropraxia, with acute shoulder pain in the arm her PNEUMOVAX was given. Nerve conduction was normal. She was sent to Physical & Occupational therapy and saw her chiro. She developed adhesion.
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Adhesion, Musculoskeletal pain, Nerve conduction studies normal, Nerve injury
Clinical narrative: Pt developed neuropraxia, with acute shoulder pain in the arm her PNEUMOVAX was given. Nerve conduction was normal. She was sent to Physical & Occupational therapy and saw her chiro. She developed adhesion.
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Musculoskeletal pain, Nerve conduction studies normal, Nerve injury
Clinical narrative: Pt developed neuropraxia, with acute shoulder pain in the arm her PNEUMOVAX was given. Nerve conduction was normal. She was sent to Physical & Occupational therapy and saw her chiro. She developed adhesion.
Age: 1.46
Sex: M
Vaccine: DTAP, DTAPIPVHIB, FLU3
Symptoms: Abasia, Body temperature fluctuation, Body temperature increased, Chest X-ray normal, Cyanosis
Clinical narrative: His symptoms started with a swollen leg (site of the injection).  His left leg was the size of a grape fruit and my son was unable to walk.  His temperature on the morning of Feb 4, 2012 was 103.  Throughout the day, my son refused to eat and drank very little.  He slept all day. When we put him down for bed we noticed he was hot -- very hot.  His temperature registered 104.  We were advised from the on-call pediatrician to give him Tylenol and push the fluids.  We did.  By 11:30 PM on Feb 12, 2012, my son's temperature was 105.  He was blue in the lips, the hands, and the toes.  His body was shaking.  The color of his skin turned into a lace like pattern of white and purple.  We took him to the ER where he was immediately put into the Code room.  The doctors wrapped his body in warmers, while trying to find a vein for an IV.  By the time he got to the ER his temperature of "off the charts," according to the doctor.  This meant, his temperature was higher than 105.5  We spent the entire evening and early morning of Feb 5 in the ER.  My son's temperature continued to spike to 104 and then fall.  This pattern repeated all night.  We were sent home and the same pattern of previous shaking, high temperature, and lack of interest in food continued until Monday, Feb at 1:30 PM.
Age: 1.46
Sex: M
Vaccine: DTAP, DTAPIPVHIB, FLU3
Symptoms: Diet refusal, Full blood count normal, Hypersomnia, Hypophagia, Injection site swelling
Clinical narrative: His symptoms started with a swollen leg (site of the injection).  His left leg was the size of a grape fruit and my son was unable to walk.  His temperature on the morning of Feb 4, 2012 was 103.  Throughout the day, my son refused to eat and drank very little.  He slept all day. When we put him down for bed we noticed he was hot -- very hot.  His temperature registered 104.  We were advised from the on-call pediatrician to give him Tylenol and push the fluids.  We did.  By 11:30 PM on Feb 12, 2012, my son's temperature was 105.  He was blue in the lips, the hands, and the toes.  His body was shaking.  The color of his skin turned into a lace like pattern of white and purple.  We took him to the ER where he was immediately put into the Code room.  The doctors wrapped his body in warmers, while trying to find a vein for an IV.  By the time he got to the ER his temperature of "off the charts," according to the doctor.  This meant, his temperature was higher than 105.5  We spent the entire evening and early morning of Feb 5 in the ER.  My son's temperature continued to spike to 104 and then fall.  This pattern repeated all night.  We were sent home and the same pattern of previous shaking, high temperature, and lack of interest in food continued until Monday, Feb at 1:30 PM.
Age: 1.46
Sex: M
Vaccine: DTAP, DTAPIPVHIB, FLU3
Symptoms: Skin discolouration, Tremor, Urine analysis normal
Clinical narrative: His symptoms started with a swollen leg (site of the injection).  His left leg was the size of a grape fruit and my son was unable to walk.  His temperature on the morning of Feb 4, 2012 was 103.  Throughout the day, my son refused to eat and drank very little.  He slept all day. When we put him down for bed we noticed he was hot -- very hot.  His temperature registered 104.  We were advised from the on-call pediatrician to give him Tylenol and push the fluids.  We did.  By 11:30 PM on Feb 12, 2012, my son's temperature was 105.  He was blue in the lips, the hands, and the toes.  His body was shaking.  The color of his skin turned into a lace like pattern of white and purple.  We took him to the ER where he was immediately put into the Code room.  The doctors wrapped his body in warmers, while trying to find a vein for an IV.  By the time he got to the ER his temperature of "off the charts," according to the doctor.  This meant, his temperature was higher than 105.5  We spent the entire evening and early morning of Feb 5 in the ER.  My son's temperature continued to spike to 104 and then fall.  This pattern repeated all night.  We were sent home and the same pattern of previous shaking, high temperature, and lack of interest in food continued until Monday, Feb at 1:30 PM.
Age: 1.46
Sex: M
Vaccine: DTAP, DTAPIPVHIB, FLU3
Symptoms: Unevaluable event
Clinical narrative: His symptoms started with a swollen leg (site of the injection).  His left leg was the size of a grape fruit and my son was unable to walk.  His temperature on the morning of Feb 4, 2012 was 103.  Throughout the day, my son refused to eat and drank very little.  He slept all day. When we put him down for bed we noticed he was hot -- very hot.  His temperature registered 104.  We were advised from the on-call pediatrician to give him Tylenol and push the fluids.  We did.  By 11:30 PM on Feb 12, 2012, my son's temperature was 105.  He was blue in the lips, the hands, and the toes.  His body was shaking.  The color of his skin turned into a lace like pattern of white and purple.  We took him to the ER where he was immediately put into the Code room.  The doctors wrapped his body in warmers, while trying to find a vein for an IV.  By the time he got to the ER his temperature of "off the charts," according to the doctor.  This meant, his temperature was higher than 105.5  We spent the entire evening and early morning of Feb 5 in the ER.  My son's temperature continued to spike to 104 and then fall.  This pattern repeated all night.  We were sent home and the same pattern of previous shaking, high temperature, and lack of interest in food continued until Monday, Feb at 1:30 PM.
Age: 1.68
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Rhinorrhoea, Sneezing
Clinical narrative: Fever, runny nose, sneezing, mild rash.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site reaction, Joint swelling, Myalgia, Oedema peripheral
Clinical narrative: Pt states 3 day muscle soreness at injection site. Swelling, pain behind knees, ankles & feet. Pt took BENADRYL.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Pt states 3 day muscle soreness at injection site. Swelling, pain behind knees, ankles & feet. Pt took BENADRYL.
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of cellulitis in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received booster dose of BOOSTRIX (unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced cellulitis. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 24 January 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 11-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 3 doses of PENTACEL, lot number C3774AA received on 04 April 2011, lot number C3801AA received on 01 July 2011 and lot number C3930AA received on 26 August 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough with whoop on 20 December 2011, approximately 4 months after the last dose. Laboratory testing included positive PCR on 08 January 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 January 2012 for 5 days. The subject was not hospitalized. At the time of the final contact on 20 January 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 31 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction
Clinical narrative: Initial report received on 24 January 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 11-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 3 doses of PENTACEL, lot number C3774AA received on 04 April 2011, lot number C3801AA received on 01 July 2011 and lot number C3930AA received on 26 August 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough with whoop on 20 December 2011, approximately 4 months after the last dose. Laboratory testing included positive PCR on 08 January 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 January 2012 for 5 days. The subject was not hospitalized. At the time of the final contact on 20 January 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 31 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.27
Sex: F
Vaccine: DTAP
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 24 January 2012 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 2-year-old female subject (initial not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System electronic database. The subject had received 3 doses of PENTACEL, lot number C3430AA received on 20 October 2009, lot number C3498AA received on 18 December 2009 and lot number C3579AA received on 18 February 2010 and a dose of DAPTACEL, lot number C3514AA on 26 November 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough with a whoop on 20 November 2011, approximately one year after the last dose. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 29 December 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 29 December 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 03 January 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 45 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.27
Sex: F
Vaccine: DTAP
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 24 January 2012 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 2-year-old female subject (initial not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System electronic database. The subject had received 3 doses of PENTACEL, lot number C3430AA received on 20 October 2009, lot number C3498AA received on 18 December 2009 and lot number C3579AA received on 18 February 2010 and a dose of DAPTACEL, lot number C3514AA on 26 November 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough with a whoop on 20 November 2011, approximately one year after the last dose. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 29 December 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 29 December 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 03 January 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 45 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema
Clinical narrative: Redness around vaccine site extending down upper arm.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Eye swelling, Rash, Urticaria
Clinical narrative: Mother noticed swelling to (R) eye & pt c/o urticaria 24 hours post vaccine, rash noted from face to trunk. 1300 - swelling to (R) eye decreased per mother.
Age: 63.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Haematochezia
Clinical narrative: After returning home from 4mo well child visit, cried for 3 1/2 hr. The next day had bowel movement with moderate amount of blood in it.
Age: 43.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Unevaluable event
Clinical narrative: Administered Tdap in left deltoid IM. Previous Tdap admin 10/26/2006.
Age: 47.0
Sex: M
Vaccine: MNQ, TDAP, TYP
Symptoms: Erythema, Pain, Rash, Tenderness
Clinical narrative: Pt received MENACTRA & typhoid in (R) deltoid and Tdap in (L) deltoid 2/1/12. On Sunday 2/5 started with redness & "small little bumps" & tenderness. Then on 2/6 bumping was gone & area was just tender, reddened with 3" diameter. Pt concerned very sore.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Inj site rxn: red, itchy, grew to size of hand. Pain in upper back & neck (ok of previous shingles infxn in late 30's). Developed headache. Rec'd to use ice on inj & APAP for HA. BENADRYL rec'd but pt didn't want to use b/c drowsy feeling assoc'd with & seen by PCP on 2-6-12. No tx prescribed - just set APAP.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: Inj site rxn: red, itchy, grew to size of hand. Pain in upper back & neck (ok of previous shingles infxn in late 30's). Developed headache. Rec'd to use ice on inj & APAP for HA. BENADRYL rec'd but pt didn't want to use b/c drowsy feeling assoc'd with & seen by PCP on 2-6-12. No tx prescribed - just set APAP.
Age: 1.12
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: 1/23/12 Febrile seizure - evaluated ER no labs or x-rays done. Temp 103.7 in ER.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling below the area of injection pain and redness.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, pain, warm to touch 8 cm Rt thigh.
Sex: F
Vaccine: HPV4
Symptoms: Seizure like phenomena, Tonic clonic movements
Clinical narrative: Information has been received from a medical student concerning a female patient with a drug reaction/allergy to penicillin who on unknown dates, was vaccinated with the first (lot# 666598/0786Z), second (lot# 036AA is not a valid lot for GARDASIL) and third dose (lot# 671006/1291AA) of GARDASIL (dose and route not reported), respectively. A few days after the third dose, the patient experienced seizure like activity. The medical student reported that the patient did not lose consciousness but had tonic clonic movements. At the time of the report, the patient was hospitalized. The patient did not have any adverse events after the first and the second dose of GARDASIL. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, MNQ
Symptoms: Cyanosis, Faecal incontinence, Fatigue, Hypoaesthesia, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no medical history who on 25-JAN-2012, was vaccinated with a first dose of GARDASIL, (lot number 668261/1397AA), (dose, route not reported) for prevention of HPV. Concomitant therapy included MENACTRA. On 26-JAN-2012, one day after receiving the first shot of GARDASIL, the patient experienced swelling at the injection site and numbness down the left arm and also on the lower left extremity. The patient also had swelling and purpling of the limbs and digits. The patient also was extremely fatigued and had uncontrollable bowel movements. On an unknown date, the patient was taken to the ER (hospital unknown) and was put on steroids and BENADRYL. Therapy with GARDASIL was not discontinued. At the time of the report the patient's outcome was recovering. The patient sought medical attention. Swelling at the injection site and numbness down the left arm and also on the lower left extremity, swelling and purpling of the limbs and digits, extremely fatigued and uncontrollable bowel movements were considered to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, MNQ
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no medical history who on 25-JAN-2012, was vaccinated with a first dose of GARDASIL, (lot number 668261/1397AA), (dose, route not reported) for prevention of HPV. Concomitant therapy included MENACTRA. On 26-JAN-2012, one day after receiving the first shot of GARDASIL, the patient experienced swelling at the injection site and numbness down the left arm and also on the lower left extremity. The patient also had swelling and purpling of the limbs and digits. The patient also was extremely fatigued and had uncontrollable bowel movements. On an unknown date, the patient was taken to the ER (hospital unknown) and was put on steroids and BENADRYL. Therapy with GARDASIL was not discontinued. At the time of the report the patient's outcome was recovering. The patient sought medical attention. Swelling at the injection site and numbness down the left arm and also on the lower left extremity, swelling and purpling of the limbs and digits, extremely fatigued and uncontrollable bowel movements were considered to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, MNQ
Symptoms: Cyanosis, Faecal incontinence, Full blood count normal, Hypoaesthesia, Injection site anaesthesia
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no medical history who on 25-JAN-2012, was vaccinated with a first dose of GARDASIL, (lot number 668261/1397AA), (dose, route not reported) for prevention of HPV. Concomitant therapy included MENACTRA. On 26-JAN-2012, one day after receiving the first shot of GARDASIL, the patient experienced swelling at the injection site and numbness down the left arm and also on the lower left extremity. The patient also had swelling and purpling of the limbs and digits. The patient also was extremely fatigued and had uncontrollable bowel movements. On an unknown date, the patient was taken to the ER (hospital unknown) and was put on steroids and BENADRYL. Therapy with GARDASIL was not discontinued. At the time of the report the patient's outcome was recovering. The patient sought medical attention. Swelling at the injection site and numbness down the left arm and also on the lower left extremity, swelling and purpling of the limbs and digits, extremely fatigued and uncontrollable bowel movements were considered to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, MNQ
Symptoms: Injection site reaction, Injection site swelling, Lethargy, Oedema peripheral, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no medical history who on 25-JAN-2012, was vaccinated with a first dose of GARDASIL, (lot number 668261/1397AA), (dose, route not reported) for prevention of HPV. Concomitant therapy included MENACTRA. On 26-JAN-2012, one day after receiving the first shot of GARDASIL, the patient experienced swelling at the injection site and numbness down the left arm and also on the lower left extremity. The patient also had swelling and purpling of the limbs and digits. The patient also was extremely fatigued and had uncontrollable bowel movements. On an unknown date, the patient was taken to the ER (hospital unknown) and was put on steroids and BENADRYL. Therapy with GARDASIL was not discontinued. At the time of the report the patient's outcome was recovering. The patient sought medical attention. Swelling at the injection site and numbness down the left arm and also on the lower left extremity, swelling and purpling of the limbs and digits, extremely fatigued and uncontrollable bowel movements were considered to be disabling. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Apparent life threatening event
Clinical narrative: This report was received from Novartis Pharmaceuticals and was assigned manufacturer report number S2012US00395, concerning a currently 20 year old female patient who on an unspecified date when she was younger, was vaccinated with a dose of MMR II (lot number, dose and route not reported). It was reported that the patient had a life threatening reaction to the vaccine. It was unknown if the patient sought medical attention. At the time of the report the patient's outcome was unknown. This was originally reported by a physician. The event was considered to be immediately life-threatening by the reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Pt. lost consciousness within 1 min of HPV injection for 2-3 seconds. Pt was monitored in exam room for 30 mins - vitals taken then repeat in 20 mins & documented in pts EHR.