chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.01
Sex: M
Vaccine: FLU3, MMR, PNC, VARCEL, FLU3, MMR, PNC, VARCEL
Symptoms: Injection site reaction, Laboratory test abnormal, Pyrexia, Rash papular, Rash pustular
Clinical narrative: Initial report received from another manufacturer, report number WAER0511USA00930, on 2/8/2006. Information was received from a physician concerning a 12 month old male patient with an allergy to Augmentin who received, on 10/21/2005, an injection of Fluzone SV 2005-2006, lot number and route and site of administration not reported, an injection of MMR II, lot number and route and site of administration not reported, a first dose, right thigh, injection of Varivax, lot number and route of administration not reported, and an injection of Prevnar, manufacturer, lot number and route and site of administration not reported. Events outlined at the beginning of this report included oral candidiasis, eye discharge and varicella. Eleven days post vaccination, on 11/1/2005, the patient developed fever of 102 degrees F and papulopustular lesions around the injection site of the right thigh. On 11/4/2005, he developed gunky eyes and continued with fever between 102 and 103 degrees F. On 11/6/2005, the patients fever was 105.2 degrees F. He was examined in an ER and started on Zithromax. It was noted that the patient was on Zyrtec as that time. Abnormal laboratory findings included C reactive Protein 12.4 mg dl (HIGH), WBC 20.7 (HIGH), hemoglobin 10.2 (LOW) and hematocrit 29.8 (LOW). A strep screen was negative. The patient was re examined by his physician on 11/7/2005, and at that time, had a cluster of lesions at the injection site of the right thigh (now x one week) and one pustule on his neck (for several days). He also had thrush on the buccal mucosa and on the left tonsil. It was noted that he had been on Augmentin since 10/28/2005. The physical examination showed that his nose/sinus, mouth/teeth, throat and skin were abnormal. The patient was treated with nystatin. Concurrent conditions listed by the reporter included an allergic reaction to antibiotics. There was no mention of hospitalization for these events. However, the patients adverse events were determined to be other important medical events by the physician (OMIC). Per the reporter, the patient had recovered.
Age: 1.01
Sex: M
Vaccine: FLU3, MMR, PNC, VARCEL, FLU3, MMR, PNC, VARCEL
Symptoms: Skin disorder, Skin ulcer, Viral infection, White blood cell count increased
Clinical narrative: Initial report received from another manufacturer, report number WAER0511USA00930, on 2/8/2006. Information was received from a physician concerning a 12 month old male patient with an allergy to Augmentin who received, on 10/21/2005, an injection of Fluzone SV 2005-2006, lot number and route and site of administration not reported, an injection of MMR II, lot number and route and site of administration not reported, a first dose, right thigh, injection of Varivax, lot number and route of administration not reported, and an injection of Prevnar, manufacturer, lot number and route and site of administration not reported. Events outlined at the beginning of this report included oral candidiasis, eye discharge and varicella. Eleven days post vaccination, on 11/1/2005, the patient developed fever of 102 degrees F and papulopustular lesions around the injection site of the right thigh. On 11/4/2005, he developed gunky eyes and continued with fever between 102 and 103 degrees F. On 11/6/2005, the patients fever was 105.2 degrees F. He was examined in an ER and started on Zithromax. It was noted that the patient was on Zyrtec as that time. Abnormal laboratory findings included C reactive Protein 12.4 mg dl (HIGH), WBC 20.7 (HIGH), hemoglobin 10.2 (LOW) and hematocrit 29.8 (LOW). A strep screen was negative. The patient was re examined by his physician on 11/7/2005, and at that time, had a cluster of lesions at the injection site of the right thigh (now x one week) and one pustule on his neck (for several days). He also had thrush on the buccal mucosa and on the left tonsil. It was noted that he had been on Augmentin since 10/28/2005. The physical examination showed that his nose/sinus, mouth/teeth, throat and skin were abnormal. The patient was treated with nystatin. Concurrent conditions listed by the reporter included an allergic reaction to antibiotics. There was no mention of hospitalization for these events. However, the patients adverse events were determined to be other important medical events by the physician (OMIC). Per the reporter, the patient had recovered.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Erythema, Hyperplasia, Injection site hypersensitivity, Injection site induration, Injection site nodule
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 2/10/2006 from a literature review. A 55 year old patient had received an influenza virus vaccination (manufacturer, lot number and site were not reported) in the right deltoid area and within a few days, developed a non tender, erythematous 1cm nodule within the inoculation site. Over the next 18 months, the nodule gradually enlarged and became indurated and pruritic. A biopsy showed MALT lymphoma. The nodular proliferation had a cellular lympho plasmacytic perivascular and periadnexal infiltration with mild cytologic atypia. In situ hybridization studies showed monotypic kappa light chain restriction within plasma cell clusters. A 4 week radiotherapy course resulted in a complete clinical regression. Eighteen months after her initial presentation, a Histopathologically similar lesion recurred on her contralateral anterior shoulder, and was excised. A second patient with the same lymphoproliferative disorder was reported and is referenced in case number 200600331.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Lymphoma, Neoplasm, Pruritus, Skin ulcer
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 2/10/2006 from a literature review. A 55 year old patient had received an influenza virus vaccination (manufacturer, lot number and site were not reported) in the right deltoid area and within a few days, developed a non tender, erythematous 1cm nodule within the inoculation site. Over the next 18 months, the nodule gradually enlarged and became indurated and pruritic. A biopsy showed MALT lymphoma. The nodular proliferation had a cellular lympho plasmacytic perivascular and periadnexal infiltration with mild cytologic atypia. In situ hybridization studies showed monotypic kappa light chain restriction within plasma cell clusters. A 4 week radiotherapy course resulted in a complete clinical regression. Eighteen months after her initial presentation, a Histopathologically similar lesion recurred on her contralateral anterior shoulder, and was excised. A second patient with the same lymphoproliferative disorder was reported and is referenced in case number 200600331.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site reaction, Pruritus
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 2/10/2006 from a literature review. A 55 year old patient had received an influenza virus vaccination (manufacturer, lot number and site were not reported) in the right deltoid area and within a few days, developed a non tender, erythematous 1cm nodule within the inoculation site. Over the next 18 months, the nodule gradually enlarged and became indurated and pruritic. A biopsy showed MALT lymphoma. The nodular proliferation had a cellular lympho plasmacytic perivascular and periadnexal infiltration with mild cytologic atypia. In situ hybridization studies showed monotypic kappa light chain restriction within plasma cell clusters. A 4 week radiotherapy course resulted in a complete clinical regression. Eighteen months after her initial presentation, a Histopathologically similar lesion recurred on her contralateral anterior shoulder, and was excised. A second patient with the same lymphoproliferative disorder was reported and is referenced in case number 200600331.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pseudo lymphoma, Skin ulcer
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 2/10/2006 from a literature review. A 55 year old patient had received an influenza virus vaccination (manufacturer, lot number and site were not reported) in the right deltoid area and within a few days, developed a non tender, erythematous 1cm nodule within the inoculation site. Over the next 18 months, the nodule gradually enlarged and became indurated and pruritic. A biopsy showed MALT lymphoma. The nodular proliferation had a cellular lympho plasmacytic perivascular and periadnexal infiltration with mild cytologic atypia. In situ hybridization studies showed monotypic kappa light chain restriction within plasma cell clusters. A 4 week radiotherapy course resulted in a complete clinical regression. Eighteen months after her initial presentation, a Histopathologically similar lesion recurred on her contralateral anterior shoulder, and was excised. A second patient with the same lymphoproliferative disorder was reported and is referenced in case number 200600331.
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Granuloma, Hyperplasia, Injection site hypersensitivity, Injection site inflammation, Injection site nodule
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 2/10/2005 from a literature review. A 65 year old patient had received an influenza virus vaccination (manufacturer, lot number and site not reported) and developed a pruritic nodule with the inoculation site in her right upper arm, which grew to 2cm in diameter within a few days after the injection. She received anti bacterial and warm compresses, but her lesions continued to grow. Six weeks after initial presentation, a biopsy showed a granulomatous and mixed cellular reactive infiltration, which was comprised of atypical but polymorphic lympho histicoytic mononuclear cells. In Situ hybridization studies showed polytypic plasma cell populations. Within one month of the biopsy, her lesion continued to grow and ulcerate, despite numerous resection attempts and oral and topical corticosteroid treatment. Three years after initial presentation, radiotherapy resulted in a complete regression of her lesion and healing of the overlying epidermis. Her lesion did not recur during nine years follow up. A second patient experienced lymphoproliferative disorder and that case is referenced in case number 200600330.
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pruritus, Skin ulcer
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 2/10/2005 from a literature review. A 65 year old patient had received an influenza virus vaccination (manufacturer, lot number and site not reported) and developed a pruritic nodule with the inoculation site in her right upper arm, which grew to 2cm in diameter within a few days after the injection. She received anti bacterial and warm compresses, but her lesions continued to grow. Six weeks after initial presentation, a biopsy showed a granulomatous and mixed cellular reactive infiltration, which was comprised of atypical but polymorphic lympho histicoytic mononuclear cells. In Situ hybridization studies showed polytypic plasma cell populations. Within one month of the biopsy, her lesion continued to grow and ulcerate, despite numerous resection attempts and oral and topical corticosteroid treatment. Three years after initial presentation, radiotherapy resulted in a complete regression of her lesion and healing of the overlying epidermis. Her lesion did not recur during nine years follow up. A second patient experienced lymphoproliferative disorder and that case is referenced in case number 200600330.
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Granuloma, Injection site hypersensitivity, Injection site nodule, Pruritus, Pseudo lymphoma
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 2/10/2005 from a literature review. A 65 year old patient had received an influenza virus vaccination (manufacturer, lot number and site not reported) and developed a pruritic nodule with the inoculation site in her right upper arm, which grew to 2cm in diameter within a few days after the injection. She received anti bacterial and warm compresses, but her lesions continued to grow. Six weeks after initial presentation, a biopsy showed a granulomatous and mixed cellular reactive infiltration, which was comprised of atypical but polymorphic lympho histicoytic mononuclear cells. In Situ hybridization studies showed polytypic plasma cell populations. Within one month of the biopsy, her lesion continued to grow and ulcerate, despite numerous resection attempts and oral and topical corticosteroid treatment. Three years after initial presentation, radiotherapy resulted in a complete regression of her lesion and healing of the overlying epidermis. Her lesion did not recur during nine years follow up. A second patient experienced lymphoproliferative disorder and that case is referenced in case number 200600330.
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Skin ulcer
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 2/10/2005 from a literature review. A 65 year old patient had received an influenza virus vaccination (manufacturer, lot number and site not reported) and developed a pruritic nodule with the inoculation site in her right upper arm, which grew to 2cm in diameter within a few days after the injection. She received anti bacterial and warm compresses, but her lesions continued to grow. Six weeks after initial presentation, a biopsy showed a granulomatous and mixed cellular reactive infiltration, which was comprised of atypical but polymorphic lympho histicoytic mononuclear cells. In Situ hybridization studies showed polytypic plasma cell populations. Within one month of the biopsy, her lesion continued to grow and ulcerate, despite numerous resection attempts and oral and topical corticosteroid treatment. Three years after initial presentation, radiotherapy resulted in a complete regression of her lesion and healing of the overlying epidermis. Her lesion did not recur during nine years follow up. A second patient experienced lymphoproliferative disorder and that case is referenced in case number 200600330.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Initial report received on 03/Feb/2006 from a health care professional. A 33 year old female patient with a history of goiter and seizures, who had not been on anti-seizure medication since September 2005, but was taking Levoxyl at the time of the vaccination, had received an intramuscular injection of DECAVAC (lot number U1620AA) in the left deltoid on 23/Jan/2006 at 12:00. Two hours later at 14:00, she experienced a seizure. She was seen by a physician and blood work, brain MRI and EEG were completed (results not reported). Per the reporter, it was unknown when was the last patient's seizure episode before the one described. At the time of the initial report, the patient had recovered from this event.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Contusion, Ecchymosis, Immune system disorder, Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: Initial report received on 2/10/2006 from an investigator participating in the above mentioned trial under the reference number P3T11. A four year old male subject was diagnosed with probable immune Thrombocytopenic purpura two days after he had received an intramuscular, left arm, first dose injection of Daptacel, lot number C2207AA, on 1/25/2006. The parent had reported a three week history of bruising on 1/27/2006 (two days post vaccination). A physical examination, on that date, revealed small ecchymotic areas on the knees and elbows. the subject had a platelet count of 103 and was referred to a specialist. The investigator considered the event an important medical event (OMIC). At the time of this report, the subject had not recovered. According to the investigator, the event was related to the study vaccine.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Abortion spontaneous, Unintended pregnancy
Clinical narrative: Initial report received on 11/2/2005 from a health care professional. A 20 year old pregnant female with no significant medical history received an intramuscular injection of Menactra, lot number U1784AA on 11/1/2005. On 11/2/2005 she took a pregnancy test and it was positive. Her last menstrual period was on 9/23/2005. The patients past obstetrical history is negative for any previous pregnancies. Seriousness criteria other medically significant (OMIC). Follow up information received on 2/13/2006 from a health care professional Per the reporter, the patient had a miscarriage the week of 11/17/2005. No other information was provided. The case was upgraded to seriousness bases on this new information.
Age: 0.09
Sex: M
Vaccine: HIBV, PNC
Symptoms: Convulsion, Crying, Cyanosis, Hypoxia, Pallor
Clinical narrative: Father called to say child awoke in early evening screaming and shaking. 3/6/06 - ER record for 2/16/06 was reviewed. Additional symptoms include facial rash and fever of 100.4.  3/9/06 - discharge summary reviewed. D/C diagnosis was 'acute life-threatening event'.  3/9/06 - Medical records reviewed. Diagnosis was 'new onset seizure'. Mental status changes were noted. Mom reported child was shivering and had blue lips. Later he appeared pale. He screamed for 45 minutes then intermittently for 6 hours. There was some arching with feeds. Mom reported baby had some nasal congestion for 2 days. Pulse ox was 88% and baby was given blow-by O2. Pulse ox improved to 92%.
Age: 0.09
Sex: M
Vaccine: HIBV, PNC
Symptoms: Screaming, Tremor
Clinical narrative: Father called to say child awoke in early evening screaming and shaking. 3/6/06 - ER record for 2/16/06 was reviewed. Additional symptoms include facial rash and fever of 100.4.  3/9/06 - discharge summary reviewed. D/C diagnosis was 'acute life-threatening event'.  3/9/06 - Medical records reviewed. Diagnosis was 'new onset seizure'. Mental status changes were noted. Mom reported child was shivering and had blue lips. Later he appeared pale. He screamed for 45 minutes then intermittently for 6 hours. There was some arching with feeds. Mom reported baby had some nasal congestion for 2 days. Pulse ox was 88% and baby was given blow-by O2. Pulse ox improved to 92%.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Anaemia, Bacterial infection, Bacterial infection, Electroencephalogram abnormal, Guillain-Barre syndrome
Clinical narrative: Progressive paralysis, admitted hospital 11/23/2005. Discharge summary states Guillain-Barre syndrome, respiratory failure, bacterial infection, anemia, hypotonia, paresthesia, decreased reflex. msv. 60 Day Follow-up Information 09-MAY-2006: Persistent paralysis and reporter dependent.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Hyporeflexia, Hyporeflexia, Hypotonia, Laboratory test abnormal, Paraesthesia
Clinical narrative: Progressive paralysis, admitted hospital 11/23/2005. Discharge summary states Guillain-Barre syndrome, respiratory failure, bacterial infection, anemia, hypotonia, paresthesia, decreased reflex. msv. 60 Day Follow-up Information 09-MAY-2006: Persistent paralysis and reporter dependent.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Paralysis, Respiratory failure, Respiratory failure
Clinical narrative: Progressive paralysis, admitted hospital 11/23/2005. Discharge summary states Guillain-Barre syndrome, respiratory failure, bacterial infection, anemia, hypotonia, paresthesia, decreased reflex. msv. 60 Day Follow-up Information 09-MAY-2006: Persistent paralysis and reporter dependent.
Age: 46.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Abdominal pain upper, Agitation, Arthralgia, Asthenia, Back pain
Clinical narrative: Ache bones and joints, acid reflux, Agitation, high cholesterol, blood pressure spikes and drops, cramps legs, dizziness, blood pressure high, feeling sluggish and hung over when no alcohol consumed, flatulence (passing gas), flu-like symptoms, gastritis, angina, energy loss, numbness and tingling arms and down one side of body, pain legs, pain lower back, pain back, pain through his body, stomach pain, pain bone and joint, pain neck, itching dry and flaky skin, infection with rash, chest pain, pains in feet like electrical shocks, charlie horse, insomnia, sleep problems, shifting sleep patterns, vertigo, blurred vision, testicular failure.
Age: 46.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Blood cholesterol increased, Bone pain, Cardiac disorder, Chest pain, Dizziness
Clinical narrative: Ache bones and joints, acid reflux, Agitation, high cholesterol, blood pressure spikes and drops, cramps legs, dizziness, blood pressure high, feeling sluggish and hung over when no alcohol consumed, flatulence (passing gas), flu-like symptoms, gastritis, angina, energy loss, numbness and tingling arms and down one side of body, pain legs, pain lower back, pain back, pain through his body, stomach pain, pain bone and joint, pain neck, itching dry and flaky skin, infection with rash, chest pain, pains in feet like electrical shocks, charlie horse, insomnia, sleep problems, shifting sleep patterns, vertigo, blurred vision, testicular failure.
Age: 46.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Dry skin, Flatulence, Gastritis, Gastrooesophageal reflux disease, Hypertension
Clinical narrative: Ache bones and joints, acid reflux, Agitation, high cholesterol, blood pressure spikes and drops, cramps legs, dizziness, blood pressure high, feeling sluggish and hung over when no alcohol consumed, flatulence (passing gas), flu-like symptoms, gastritis, angina, energy loss, numbness and tingling arms and down one side of body, pain legs, pain lower back, pain back, pain through his body, stomach pain, pain bone and joint, pain neck, itching dry and flaky skin, infection with rash, chest pain, pains in feet like electrical shocks, charlie horse, insomnia, sleep problems, shifting sleep patterns, vertigo, blurred vision, testicular failure.
Age: 46.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Hypoaesthesia, Infection, Influenza like illness, Insomnia, Muscle spasms
Clinical narrative: Ache bones and joints, acid reflux, Agitation, high cholesterol, blood pressure spikes and drops, cramps legs, dizziness, blood pressure high, feeling sluggish and hung over when no alcohol consumed, flatulence (passing gas), flu-like symptoms, gastritis, angina, energy loss, numbness and tingling arms and down one side of body, pain legs, pain lower back, pain back, pain through his body, stomach pain, pain bone and joint, pain neck, itching dry and flaky skin, infection with rash, chest pain, pains in feet like electrical shocks, charlie horse, insomnia, sleep problems, shifting sleep patterns, vertigo, blurred vision, testicular failure.
Age: 46.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Neck pain, Pain, Paraesthesia, Pruritus, Rash
Clinical narrative: Ache bones and joints, acid reflux, Agitation, high cholesterol, blood pressure spikes and drops, cramps legs, dizziness, blood pressure high, feeling sluggish and hung over when no alcohol consumed, flatulence (passing gas), flu-like symptoms, gastritis, angina, energy loss, numbness and tingling arms and down one side of body, pain legs, pain lower back, pain back, pain through his body, stomach pain, pain bone and joint, pain neck, itching dry and flaky skin, infection with rash, chest pain, pains in feet like electrical shocks, charlie horse, insomnia, sleep problems, shifting sleep patterns, vertigo, blurred vision, testicular failure.
Age: 46.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Skin disorder, Sleep disorder, Sluggishness, Testicular disorder, Vertigo
Clinical narrative: Ache bones and joints, acid reflux, Agitation, high cholesterol, blood pressure spikes and drops, cramps legs, dizziness, blood pressure high, feeling sluggish and hung over when no alcohol consumed, flatulence (passing gas), flu-like symptoms, gastritis, angina, energy loss, numbness and tingling arms and down one side of body, pain legs, pain lower back, pain back, pain through his body, stomach pain, pain bone and joint, pain neck, itching dry and flaky skin, infection with rash, chest pain, pains in feet like electrical shocks, charlie horse, insomnia, sleep problems, shifting sleep patterns, vertigo, blurred vision, testicular failure.
Age: 46.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Vision blurred
Clinical narrative: Ache bones and joints, acid reflux, Agitation, high cholesterol, blood pressure spikes and drops, cramps legs, dizziness, blood pressure high, feeling sluggish and hung over when no alcohol consumed, flatulence (passing gas), flu-like symptoms, gastritis, angina, energy loss, numbness and tingling arms and down one side of body, pain legs, pain lower back, pain back, pain through his body, stomach pain, pain bone and joint, pain neck, itching dry and flaky skin, infection with rash, chest pain, pains in feet like electrical shocks, charlie horse, insomnia, sleep problems, shifting sleep patterns, vertigo, blurred vision, testicular failure.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain, Pruritus
Clinical narrative: (OMIC) I had a flu shot and I have a two numb fingers and my arm was very sore and itching and my arm feels numb only my half of my arm, I do not have any medical and I am waiting okay for some financial help. I have had flu shots before and never in my life have I had this reaction. This is the worst flu shot I have ever had. Nothing showed up until about 3 weeks after. My arm is not getting any better. I did not ask for this. I tried taking vitamin be for my nerves but it has not went away. Fluarix is the vaccine and it is bad. I will have to work this out. In the mean time I want someone to know about this. The numbness is no fun and I hope this vaccine wares off if not my arm is permanently have numb and I have to live with this.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Client reported developing "hives" the evening of 12/23/05.  Was seen ER 12/24/05-was told that hives were probably not related to flu vaccine, unknown what caused hives. Given steroid and Benadryl to take.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Pruritus, Swelling
Clinical narrative: Soreness at site of pneumonia vaccine 1st night, some itching noted-redness and swelling noted from shoulder to elbow. Lasted 2 weeks. 1st called 11/4/05-noted some improvement after five days 11/4/05. Follow up 12/1/05.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Myalgia
Clinical narrative: Client reports soreness in L deltoid after receiving flu vaccine. Soreness has never gone away and has increased in intensity. Also complained of limited range of motion with L arm. Saw PMD 1/25/06-referred to vaccine provider. Referred back to PMD.
Age: 1.03
Sex: F
Vaccine: FLU3, PNC, VARCEL
Symptoms: Convulsion, Drooling, Muscle twitching, Pyrexia, Stupor
Clinical narrative: Pt had seizure 5 minutes after administration of 12 month immunization. Seen in  ER had T 103. Fine 2 minutes after event. No further fever or seizure. Information recieved from Medical records states staring, drooling sliva and jerking as additional symptoms. msv
Age: 1.26
Sex: M
Vaccine: DTAP, FLU3, MMR
Symptoms: Erythema, Urticaria
Clinical narrative: Approx 15 minutes after immunizations were given-child's face became red and developed hives-resolved quickly.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Headache
Clinical narrative: Received shot at 11:00 AM, approx 4:30 PM patient began feeling short of breath a little, with a lump in the base of my throat, kind of dizzy, arm was achy and sore in antecubital area. These sx slightly improved around 6 and by 7:30 PM were gone. Approx 10 PM pt. was hit with the typical flu sx: shivering/chills, extremely achy, weak, headache, tired. Pt. went to bed and in AM was fine.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Myalgia, Pain
Clinical narrative: Received shot at 11:00 AM, approx 4:30 PM patient began feeling short of breath a little, with a lump in the base of my throat, kind of dizzy, arm was achy and sore in antecubital area. These sx slightly improved around 6 and by 7:30 PM were gone. Approx 10 PM pt. was hit with the typical flu sx: shivering/chills, extremely achy, weak, headache, tired. Pt. went to bed and in AM was fine.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthma, Bronchitis, Cough
Clinical narrative: Exacerbation of asthma, cough and MD diagnosis bronchitis.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Laboratory test abnormal, Vaccination complication
Clinical narrative: Patient given flu vaccine on 10-18-05 and had symptoms of flu on 1-18-06. Pt confirmed with flu by throat culture. Pt had Influenza A. Possible vaccine failure.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness, Oedema peripheral
Clinical narrative: I had flu shot about 3:00 PM Nov 15. 6:30 AM Nov 16 my left leg would not hold me up. 8 days later I could walk normal. My three middle toes on left foot swelled up. I could only wear sneakers. Ball of left foot swelled and to this day I feel like I'm walking on a wad of gum and my toes are still numb.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Dehydration, Diarrhoea, Vomiting
Clinical narrative: Child received influenza vaccine on 1-11-06. On 1-13-06 mother phoned in stating since 4 am on 1-13-06 child vomiting. Small diarrhea stool noted. Mother instructed to call family physician due to concern of dehydration.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Laboratory test abnormal, Pericarditis
Clinical narrative: Chest pain that is positional and started on post vaccine day 11. Echo cardiogram is normal but EKG shows typical signs of pericarditis.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Screaming
Clinical narrative: Mother called: Stated child was "screaming" most of day and inconsolable after vaccines.
Age: 1.01
Sex: F
Vaccine: CHOL, VARCEL
Symptoms: Injection site erythema, Swelling
Clinical narrative: Mother called 2/18/06. Reported child's arm, swollen, red at injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Rash, Urticaria
Clinical narrative: Developed rash and hives 4:20 PM. Fast melt Benadryl 12.5mg (children tablet)- per Dr.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cervical polyp, Pharyngolaryngeal pain, Pyrexia, Rash macular, Rash papular
Clinical narrative: Day 8 after MMR fever 103 and maculopapular rash. Symptomatic treatment. Also had enlarged cervical nodes, red throat without lesions, mild runny nose. No pruritus.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: Day 8 after MMR fever 103 and maculopapular rash. Symptomatic treatment. Also had enlarged cervical nodes, red throat without lesions, mild runny nose. No pruritus.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Musculoskeletal stiffness, Pain, Pruritus
Clinical narrative: Left arm swollen, red, warm to touch, "very tight". Patient complained of itching and pain. Benadryl and Motrin advised.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Swelling
Clinical narrative: Left arm swollen, red, warm to touch, "very tight". Patient complained of itching and pain. Benadryl and Motrin advised.
Age: 1.25
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Insomnia, Irritability, Rash
Clinical narrative: Approx 8 days after receiving vaccinations, pt broke out in a rash on abdomen. By day 9 the rash had spread all over the trunk of pt, beginning to spread up the back of her neck and down legs. Rash completely stopped at "bikini area" where diaper covered. Pt. fussy, could not sleep.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Erythema, Insomnia, Irritability, Pruritus
Clinical narrative: 7 days after receiving vaccination pt broke out in a rash on abdomen-on 8th day rash worsened, got redder and spread all over trunk, down legs and up back neck. Pt acted like rash itched mom stated. Pt very fussy couldn't sleep and a decrease in appetite for 2 days was noted. Rash still 2/20/06.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: 7 days after receiving vaccination pt broke out in a rash on abdomen-on 8th day rash worsened, got redder and spread all over trunk, down legs and up back neck. Pt acted like rash itched mom stated. Pt very fussy couldn't sleep and a decrease in appetite for 2 days was noted. Rash still 2/20/06.
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Pneumococcal vaccine given in deltoid IM. Next day arm swollen, hot, red from shoulder to elbow. Pain with movement.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Pyrexia
Clinical narrative: Mom stated that child had a temperature of 107 degrees the day after child received the vaccine on 8-17-05. Mom telephoned health department and told them about this. They told mom to give child Tylenol. Mom gave 1 dose of Tylenol and temp went down to normal.
Age: 1.27
Sex: M
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Dyspnoea, Heart rate increased, Pyrexia, Rash
Clinical narrative: Patient came into doctor office at 1530 with SOB, increased pulse rate, temperature, and red rash on trunk and legs. Nebulized breathing treatment of Albuterol given twice and patient responding well. Patient left at 1645 with mom. Patient given Pediatric Singulair and instructions if he gets worse.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Medication error
Clinical narrative: Spoke with shots line. No adverse reactions noted per shots line representative (nurse). 0.5 of TB was given instead of 0.5 of Td (child).
Age: 35.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Blister, Injection site hypersensitivity, Pruritus
Clinical narrative: Client states she had elliptical nickel sized area (Right arm) when vaccine given that itched and developed blisters the day vaccine was given. Client left town - call to  report on 12/30/05. Stated blisters were resolving but still there. Not in area where band aid was placed.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: States arm hurt - stinging at site within 3 hours of vaccinations. Continued to worsen in pain, noticed pinkish color at site. Progressively got worse over next 5 days at which time client went to local ER - given pill to swallow and script for Benadryl. Called us on 12/1 and interviewed on 12/2. Arm improved as of today.
Age: 2.0
Sex: F
Vaccine: DTAP, PNC
Symptoms: Lethargy, Pyrexia, Somnolence
Clinical narrative: Sleeping/lethargy. High fever 105 for 12 hours.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain, Arthralgia, Back pain, Decreased appetite, Dehydration
Clinical narrative: Weight loss, generally not feeling well and worsening over a few days - joint pain, fatigue, aches, swollen lymph glands, decreased appetite (severe dehydration per patient report), low grade fever, nausea and neutropenia, non-specific abdominal pain, headache, diarrhea, muscle pain, skin pain, eye pain, kidney (back flank area) pain, pale, throbbing for 3 hours at injection site on day 14, pressure 4" diameter.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Eye pain, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Weight loss, generally not feeling well and worsening over a few days - joint pain, fatigue, aches, swollen lymph glands, decreased appetite (severe dehydration per patient report), low grade fever, nausea and neutropenia, non-specific abdominal pain, headache, diarrhea, muscle pain, skin pain, eye pain, kidney (back flank area) pain, pale, throbbing for 3 hours at injection site on day 14, pressure 4" diameter.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Malaise, Myalgia, Nausea, Neutropenia, Pain
Clinical narrative: Weight loss, generally not feeling well and worsening over a few days - joint pain, fatigue, aches, swollen lymph glands, decreased appetite (severe dehydration per patient report), low grade fever, nausea and neutropenia, non-specific abdominal pain, headache, diarrhea, muscle pain, skin pain, eye pain, kidney (back flank area) pain, pale, throbbing for 3 hours at injection site on day 14, pressure 4" diameter.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Pallor, Pyrexia, Weight decreased
Clinical narrative: Weight loss, generally not feeling well and worsening over a few days - joint pain, fatigue, aches, swollen lymph glands, decreased appetite (severe dehydration per patient report), low grade fever, nausea and neutropenia, non-specific abdominal pain, headache, diarrhea, muscle pain, skin pain, eye pain, kidney (back flank area) pain, pale, throbbing for 3 hours at injection site on day 14, pressure 4" diameter.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Contusion, Faeces discoloured, Rash, Skin discolouration
Clinical narrative: Patient received Hep A #1 1/9/06. Mother called 1/12/06 to report bruising on shins, forehead, arms. Injection site purple. Tiny dots on chest, face, tip of tongue. Mother reports bright green "poop" for 2 days prior to Hep A IZ. 1/17/06, mother reports reaction not related to Hep A IZ per MD.
Age: 0.41
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Seen in village clinic and vaccinated - then taken to grandma's where baby slept. Mom and baby went home and infant slept again - when he woke in the evening had total body hives - afebrile. Treated with Benadryl at clinic with good resolution of most hives by morning. No new foods or exposures.
Age: 0.44
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Febrile convulsion, Laboratory test abnormal, Pyrexia, Tremor
Clinical narrative: Family woke to infant in body shaking seizure which lasted 6 minutes from time they awoke to finish. Start of seizure not witnessed. Felt hot at home. Upon ambulance arrival, baby's temp about 101.8 (right). History of non-febrile febrile seizure on 12/26/05. EEG/Cat Scan/MRI to be done. MD diagnosis: febrile seizure for 12/31/05 visit.
Age: 1.67
Sex: M
Vaccine: DTAP, PNC
Symptoms: Pruritus, Rash, Skin burning sensation
Clinical narrative: On 12/10/05 pt developed rash on face that looked like impetigo. Rash spread to rest of body, accompanied by itching and burning. Cleared within 2 day with single dose of Benadryl. No respiratory involvement, no recurrence of sx since 12/17/05.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Dyspnoea, Irritability, Rash, Urticaria
Clinical narrative: Patient began to develop a hive type rash on his face and abdomen on his way home from the clinic after hepatitis A immunization. He became very irritable and mother described breathing as not normal. Parents contacted the health center and I agreed with his mother that it would be the best to administer Benadryl and have him evaluated at the hospital. His mother could not think of anything else on their trip to town and the clinic that may have triggered the response. He has no history of allergic reactions. He was much improved by the time they got to the ER at the hospital. No treatment was needed and his symptoms were resolving. The attending physician documented allergy to hepatitis A vaccine in patient medical record and prescribed Epinephrine Auto-injector 0.15mg in case of further symptoms. Mother reports patient continued to improve and no further consultation or treatment was needed.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Client experienced unusual rash approx. 24 hr after receiving the following vaccines: Dtap, Hib, PCV7 and MMR. Rash described as diffuse "bumps" on legs, back, arms and torso. Some of them were red and became "itchy" with time. Eval by FNP completed with unknown diagnosis. Symptoms resolved in approx 1 week with treatment.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Arm swelling, red, warm, painful when touched.
Age: 21.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Erythema, Rash, Rash macular
Clinical narrative: Patient woke up 2/11/06 AM with 2 small areas (about 1.5" diameter), outlined with redness, centers had blotchy redness. No raised areas; no itching. Each area occurred about 1" above injection site on each arm. Rashes identical no both arms. No fever. Resolving as of 2/13/06.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Lacrimation increased, Pruritus, Pyrexia, Swelling
Clinical narrative: Redness, swelling, itching, watery eyes, localized fever. From day of injection, symptoms got progressively worse until after treatment w/anti-histamines.
Age: 5.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema, Pain, Pruritus
Clinical narrative: Left arm edematous and erythematous and form. Painful and itchy.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Swelling
Clinical narrative: Swollen arm (deltoid) area.
Age: 7.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Erythema, Tenderness
Clinical narrative: Erythema and tenderness to left arm less than 24 hours after injection (5.5x4").
Age: 6.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Left arm erythematous patch at site of injection within a few minutes. No other symptoms and no evidence of respiratory problems.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Irritability, Malaise
Clinical narrative: Injection given 2/9/06 without problem and mother noted malaise next day and minimal irritability with gradually increasing erythematous macule 2/10-11 at injection site. No dyspnea, wheeze, fever.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Abnormal behaviour, Crying, Feeling abnormal, Pyrexia
Clinical narrative: Child received vaccine 2/10/06 - mother phoned 2/15/06 - states child has been crying and fuzzy since 2/11/06- fever 100.5 - abnormal behavior for child.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Abnormal behaviour, Crying, Irritability, Pyrexia
Clinical narrative: Child received vaccine 2/10/06 - mother phoned 2/15/06 - states child has been crying and fuzzy since 2/11/06- fever 100.5 - abnormal behavior for child.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Generalized hives (urticaria) began within half hour after administering shots. No other symptoms, only hives.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site warmth
Clinical narrative: Approx. 4 hours after inj pt called c/o red, warm, 'tight' left deltoid (inj site). Encourage antihistamine and icing area. RC in 4 hours found pts arm red, warm and indurated with diff raising arm due to "tightness @ arm" otherwise felt fine.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Irritability, Rash
Clinical narrative: My daughter developed a rash on her trunk area on the morning or February 17th.  As the day went on, the rash progressed to her neck, behind her ears, scalp, diaper area and face.  The rash became more severe and at its worst point the whole area was almost entirely bright red.  Baby was very irritated by rash.  Rash was gone in about 36 hours.  Did not visit Dr's office as it was a Friday night/Sat morning.
Age: 27.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Nausea
Clinical narrative: Stabbing abdominal pain with nausea. Patient removed from flying duty for 2 days and told to use OTC treatment.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Infection, Lymphadenopathy, Urticaria
Clinical narrative: 6 HOURS AFTER I RECEIVED THE VACCINATION IN MY RIGHT ARM, I STARTED TO GET RED WELTS ON THE SIDE OF MY NECK. THEN IT WENT TO THE SIDE OF MY FACE AND THE BACK OF MY NECK. MY GLAND RIGHT UNDER MY EAR IS SWOLLEN. I HAVE SWOLLEN LUMPS ON THE BACK OF MY NECK AND SHOULDER. MY RIGHT SHOULDER IS IN A LOT OF PAIN. I WAS GIVEN A BENADRYL INJECTION. I HAVE BEEN TAKING THE PILL BENADRYL. THE DOCTOR SAYS THAT IT WILL TAKE MAYBE A WEEK TO GO DOWN. I AM GOING TO SEE ANOTHER DOCTOR . I THINK THE GLAND UNDER MY EAR MAY BE INFECTED FROM THE VACCINE.
Age: 8.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: 2/9/06 Right arm swollen with rash from site of injection radiating to right elbow.  Using ice pack to area.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HEP
Symptoms: Grunting, Irritability, Opisthotonus, Pyrexia, Screaming
Clinical narrative: Immediately after the vaccine, mild increase in temperature (Childrens Tylenol was given to bring it down).  Later that night and since, child was grunting, throwing self into spinal extension, sleeping habits broken with bouts of unusual screaming and fussiness.  Still ongoing.
Age: 45.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Difficulty in walking, Joint stiffness, Rash
Clinical narrative: Rash 3 days now. Painful, stiff knees; difficult to walk.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Eye discharge, Eyelid oedema, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling at site left arm. Fever 103. Hives on face and arm. Right eyelid swelling with drainage.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Urticaria
Clinical narrative: Redness and swelling at site left arm. Fever 103. Hives on face and arm. Right eyelid swelling with drainage.
Age: 4.0
Sex: F
Vaccine: HIBV, IPV, MMR, VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Student broke out on Wednesday 2/1/06 during the evening at home. Stayed home until returning to school on 2/9/06. Mother reports less than 50 spots, no fever. Chicken pox.
Age: 1.53
Sex: F
Vaccine: DTAP, PNC
Symptoms: Anorexia, Diarrhoea, Pyrexia, Staring
Clinical narrative: 48 hr after Dtap and Prevnar pt developed fever, diarrhea, loss of appetite, staring spells.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Rash macular
Clinical narrative: 7cmx6cm erythematous macular reaction right upper anterior thigh (no cellulitis).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site swelling
Clinical narrative: Swelling, redness, induration in right thigh, where DTaP and IPV were administered.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: Rash under breast line, then welts started all over head, feet, face, legs, back. Rash started 2/17/06.
Age: 1.24
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Skin ulcer
Clinical narrative: Pt presented to office on 2/18/06 with a hx of vesicles x 3 d. Fever on and off x 3 d. Generalized lesions over entire body 100 +. Tx Aveeno, Benadryl, Calamine, Tylenol. No ASA, isolate.
Age: 0.39
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Pyrexia, Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a certified medical assistant concerning a 2 week old female who on 1/27/2005 was vaccinated in the right thigh with a dose of Hib conj vaccine (OMPC) (lot 648808/0364P). Concomitant vaccine therapy included a dose given in the right thigh of Diphtheria toxoid (+) hep B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3 component (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX) and a doe of PCB in the left thigh. On 2/1/2005 the patient presented to the ER with a diagnosis of rash of unknown etiology. The rash started at the right thigh thigh, then spread all over her body. She was treated with oral diphenhydramine (Benadryl), 1 tsp every 6 hours. She was not hospitalized. Prior to the ER visit the mother of the child had been treating the child with acetaminophen Tylenol for fever. Subsequently, the patient recovered. The medical assistant stated that after this incident the patient was given vaccines (unspecified) individually with no problem. On 5/11/2005 the patient was vaccinated in the left thigh with a dose of Hib conj vaccine (OMPC) (lot 650357/0083R) and developed a rash again. the patients out come was unknown. No product quality complaint was involved. Rash and fever was considered other important medical events (OMIC). No further information is expected.