chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: HEPA, IPV, TD, TYP, YF
Symptoms: Vomiting
Clinical narrative: HA, vomiting, Bell's Palsy, Encephalitis. Hospitalized. Serum sent to CDC for yellow fever testing. Follow-up: 06-Aug-2007 year the investigation BELL's Palsy has been resolved. Symptoms of shoulder/neck pain continues. Reminder: This case originates from FM025 which is a post marketing observation study.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Eyelid retraction, Facial palsy, Headache, Nasal congestion, Paraesthesia
Clinical narrative: The child was participating in a post-marketing evaluation of the safety of influenza virus vaccine live, intranasal (Flumist) in healthy children and healthy adults 5 through 49 years of age. A report was received a Bell's Palsy coincident to FluMist. A ten year old male received FluMist on 18Nov05 and was diagnosed with Bell's Palsy coincident to FluMist. A ten year old male received FluMist on 18Nov05 and was diagnosed with Bell's Palsy on 20Nov05. On 16Nov05, the child was seen in the ER for a headache at the left occiput (pain radiating to the left jaw, tingling on left side of face, runny nose, and nasal congestion. At that time, the child denied numbness or ear pain, but did mention being hit in the head with a dodge ball two weeks prior to that ER visit. On 20Nov05, the child was unable to fully close the left eyelid, could not move the left side of the mouth or face, had decreased sensation in the left side of the face and was diagnosed with mild Bell's Palsy. The child was able to raise his eyebrows and the rest of the neurological examination was within normal limits. The child was treated with prednisolone 30mg twice a day for ten days (to be weaned as per protocol). And acyclovir 400mg by mouth five times per day for ten days. A recommendation was made to check the child in one month; however, the recommendation was not adhered to and no visits were on record since 20Nov05. The outcome of the event was not reported. The reporter assessed the event as possibly related to Flumist. Follow-up: 08 Dec 06 per the investigation, since 30 Jun 06, there was no mention made of BELL's Palsy Tx. Reminder: This case ongoing from FM025 which is a study.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Rhinorrhoea, Sensory disturbance
Clinical narrative: The child was participating in a post-marketing evaluation of the safety of influenza virus vaccine live, intranasal (Flumist) in healthy children and healthy adults 5 through 49 years of age. A report was received a Bell's Palsy coincident to FluMist. A ten year old male received FluMist on 18Nov05 and was diagnosed with Bell's Palsy coincident to FluMist. A ten year old male received FluMist on 18Nov05 and was diagnosed with Bell's Palsy on 20Nov05. On 16Nov05, the child was seen in the ER for a headache at the left occiput (pain radiating to the left jaw, tingling on left side of face, runny nose, and nasal congestion. At that time, the child denied numbness or ear pain, but did mention being hit in the head with a dodge ball two weeks prior to that ER visit. On 20Nov05, the child was unable to fully close the left eyelid, could not move the left side of the mouth or face, had decreased sensation in the left side of the face and was diagnosed with mild Bell's Palsy. The child was able to raise his eyebrows and the rest of the neurological examination was within normal limits. The child was treated with prednisolone 30mg twice a day for ten days (to be weaned as per protocol). And acyclovir 400mg by mouth five times per day for ten days. A recommendation was made to check the child in one month; however, the recommendation was not adhered to and no visits were on record since 20Nov05. The outcome of the event was not reported. The reporter assessed the event as possibly related to Flumist. Follow-up: 08 Dec 06 per the investigation, since 30 Jun 06, there was no mention made of BELL's Palsy Tx. Reminder: This case ongoing from FM025 which is a study.
Age: 40.0
Sex: M
Vaccine: FLUN3
Symptoms: Anxiety, Back pain, Discomfort, Facial palsy, Migraine
Clinical narrative: The patient was participation in a post marketing evaluation of the safety of influenza virus vaccine live, intranasal flu mist in health children and healthy adults 5 through 49 years of age. A report was received of Bells palsy, neck pain, shoulder pain, and discomfort around the right ear coincident of FluMist. A 40 year old male with a history of migraines, anxiety, arthroscopic surgery, and chronic back pain, received FluMist on 11/25/2006 and developed Bells Palsy on 12/3/05. The patient reported several days of neck and shoulder pain that occasionally radiated to the right arm (no weakness or numbness) and one to two days of discomfort around the right ear. The patient was taking hydrocodone acetaminophen for pain due to recent arthroscopic surgery in 11/21/05. ON 12/14/05, the event of Bells Palsy was considered resolved. The outcome for the events of neck and shoulder pain were not provided. The reporter assessed the event of Bells palsy as possibly related to FluMist. The reporter did not provide a statement of causality for the events of neck and shoulder pain. This case is linked to MEDI0004189 (patient experienced pneumonia after receiving FluMist.
Age: 40.0
Sex: M
Vaccine: FLUN3
Symptoms: Neck pain, Pain, Shoulder pain
Clinical narrative: The patient was participation in a post marketing evaluation of the safety of influenza virus vaccine live, intranasal flu mist in health children and healthy adults 5 through 49 years of age. A report was received of Bells palsy, neck pain, shoulder pain, and discomfort around the right ear coincident of FluMist. A 40 year old male with a history of migraines, anxiety, arthroscopic surgery, and chronic back pain, received FluMist on 11/25/2006 and developed Bells Palsy on 12/3/05. The patient reported several days of neck and shoulder pain that occasionally radiated to the right arm (no weakness or numbness) and one to two days of discomfort around the right ear. The patient was taking hydrocodone acetaminophen for pain due to recent arthroscopic surgery in 11/21/05. ON 12/14/05, the event of Bells Palsy was considered resolved. The outcome for the events of neck and shoulder pain were not provided. The reporter assessed the event of Bells palsy as possibly related to FluMist. The reporter did not provide a statement of causality for the events of neck and shoulder pain. This case is linked to MEDI0004189 (patient experienced pneumonia after receiving FluMist.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Abasia, Alanine aminotransferase increased, Blood alkaline phosphatase increased, Blood bicarbonate decreased, Blood bilirubin increased
Clinical narrative: Post Marketing Evaluation of the Safety of Influenza Virus vaccine live intranasal FluMist in healthy children and healthy adults 5 through 49 years of age. This is a 43 year old female who received FluMist on 11/14/05 and was diagnosed with Guillain Barre syndrome. On 1/26/06 at approximately 2am, the patient woke up and walked to the bathroom. She reported having difficulty using her right hand and almost fell down while she was walking to the toilet. She was seen at a hospital and was found to have a low potassium level of 2.8 which was repleted to 3.2. She also complained of a headache and neck stiffness, head CT was negative and a lumbar puncture was negative aside from and elevated CSF protein of 67. She was discharged home. A week prior to this event, she complained of flu like illness. At home, she was unable to walk and became almost quadriplegic. She was then brought to the emergency room. In the ER, neurology was consulted and an EMG was done with findings that were was strongly suggestive of Guillain Barre syndrome. She was then given Dilaudid 1mg IV and intravenous immunoglobulin IVIG was started at 400mg KG day to complete a total of 5 days. Other treatment include plasmapheresis. During the course of her hospitalization, she was also diagnosed with depression and was placed on Prozac (Fluoxetine). She was discharged after 31 days to a skilled nursing facility. In the SNF, Dilaudid was continued for pain management together with Fentanyl patch. As of 4/18/06, the rehabilitation notes indicated that the patient remains dependent on all activities of daily living although she continues to show increased strength for trunk and hip control. The SNF consult notes also indicated that she does not have sufficient motor neuron recovered to give significant gains in functional mobility. Physical therapy in ongoing. Medications in the SNF included. Subcutaneous Heparin, Tylenol, Nevacor (Lovastatin), Prilosec (omeprazole), Quinine sulfate, Elavil (amitriptyline), Fentanyl patch, Dilaudid, Ativan (alprazolam), Colace (docusate sodium), Senna, Dulcolax (bisacodyl), milk of magnesia, oil enema, Nasarel and artificial tears. The patient has not yet recovered. The reporter has assessed this event as not related to FluMist.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Blood calcium increased, Blood chloride increased, Blood creatinine increased, Blood glucose increased, Blood sodium increased
Clinical narrative: Post Marketing Evaluation of the Safety of Influenza Virus vaccine live intranasal FluMist in healthy children and healthy adults 5 through 49 years of age. This is a 43 year old female who received FluMist on 11/14/05 and was diagnosed with Guillain Barre syndrome. On 1/26/06 at approximately 2am, the patient woke up and walked to the bathroom. She reported having difficulty using her right hand and almost fell down while she was walking to the toilet. She was seen at a hospital and was found to have a low potassium level of 2.8 which was repleted to 3.2. She also complained of a headache and neck stiffness, head CT was negative and a lumbar puncture was negative aside from and elevated CSF protein of 67. She was discharged home. A week prior to this event, she complained of flu like illness. At home, she was unable to walk and became almost quadriplegic. She was then brought to the emergency room. In the ER, neurology was consulted and an EMG was done with findings that were was strongly suggestive of Guillain Barre syndrome. She was then given Dilaudid 1mg IV and intravenous immunoglobulin IVIG was started at 400mg KG day to complete a total of 5 days. Other treatment include plasmapheresis. During the course of her hospitalization, she was also diagnosed with depression and was placed on Prozac (Fluoxetine). She was discharged after 31 days to a skilled nursing facility. In the SNF, Dilaudid was continued for pain management together with Fentanyl patch. As of 4/18/06, the rehabilitation notes indicated that the patient remains dependent on all activities of daily living although she continues to show increased strength for trunk and hip control. The SNF consult notes also indicated that she does not have sufficient motor neuron recovered to give significant gains in functional mobility. Physical therapy in ongoing. Medications in the SNF included. Subcutaneous Heparin, Tylenol, Nevacor (Lovastatin), Prilosec (omeprazole), Quinine sulfate, Elavil (amitriptyline), Fentanyl patch, Dilaudid, Ativan (alprazolam), Colace (docusate sodium), Senna, Dulcolax (bisacodyl), milk of magnesia, oil enema, Nasarel and artificial tears. The patient has not yet recovered. The reporter has assessed this event as not related to FluMist.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Blood urea increased, CSF test abnormal, Depression, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Post Marketing Evaluation of the Safety of Influenza Virus vaccine live intranasal FluMist in healthy children and healthy adults 5 through 49 years of age. This is a 43 year old female who received FluMist on 11/14/05 and was diagnosed with Guillain Barre syndrome. On 1/26/06 at approximately 2am, the patient woke up and walked to the bathroom. She reported having difficulty using her right hand and almost fell down while she was walking to the toilet. She was seen at a hospital and was found to have a low potassium level of 2.8 which was repleted to 3.2. She also complained of a headache and neck stiffness, head CT was negative and a lumbar puncture was negative aside from and elevated CSF protein of 67. She was discharged home. A week prior to this event, she complained of flu like illness. At home, she was unable to walk and became almost quadriplegic. She was then brought to the emergency room. In the ER, neurology was consulted and an EMG was done with findings that were was strongly suggestive of Guillain Barre syndrome. She was then given Dilaudid 1mg IV and intravenous immunoglobulin IVIG was started at 400mg KG day to complete a total of 5 days. Other treatment include plasmapheresis. During the course of her hospitalization, she was also diagnosed with depression and was placed on Prozac (Fluoxetine). She was discharged after 31 days to a skilled nursing facility. In the SNF, Dilaudid was continued for pain management together with Fentanyl patch. As of 4/18/06, the rehabilitation notes indicated that the patient remains dependent on all activities of daily living although she continues to show increased strength for trunk and hip control. The SNF consult notes also indicated that she does not have sufficient motor neuron recovered to give significant gains in functional mobility. Physical therapy in ongoing. Medications in the SNF included. Subcutaneous Heparin, Tylenol, Nevacor (Lovastatin), Prilosec (omeprazole), Quinine sulfate, Elavil (amitriptyline), Fentanyl patch, Dilaudid, Ativan (alprazolam), Colace (docusate sodium), Senna, Dulcolax (bisacodyl), milk of magnesia, oil enema, Nasarel and artificial tears. The patient has not yet recovered. The reporter has assessed this event as not related to FluMist.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Haematocrit decreased, Headache, Hypokalaemia, Hypokinesia, Influenza like illness
Clinical narrative: Post Marketing Evaluation of the Safety of Influenza Virus vaccine live intranasal FluMist in healthy children and healthy adults 5 through 49 years of age. This is a 43 year old female who received FluMist on 11/14/05 and was diagnosed with Guillain Barre syndrome. On 1/26/06 at approximately 2am, the patient woke up and walked to the bathroom. She reported having difficulty using her right hand and almost fell down while she was walking to the toilet. She was seen at a hospital and was found to have a low potassium level of 2.8 which was repleted to 3.2. She also complained of a headache and neck stiffness, head CT was negative and a lumbar puncture was negative aside from and elevated CSF protein of 67. She was discharged home. A week prior to this event, she complained of flu like illness. At home, she was unable to walk and became almost quadriplegic. She was then brought to the emergency room. In the ER, neurology was consulted and an EMG was done with findings that were was strongly suggestive of Guillain Barre syndrome. She was then given Dilaudid 1mg IV and intravenous immunoglobulin IVIG was started at 400mg KG day to complete a total of 5 days. Other treatment include plasmapheresis. During the course of her hospitalization, she was also diagnosed with depression and was placed on Prozac (Fluoxetine). She was discharged after 31 days to a skilled nursing facility. In the SNF, Dilaudid was continued for pain management together with Fentanyl patch. As of 4/18/06, the rehabilitation notes indicated that the patient remains dependent on all activities of daily living although she continues to show increased strength for trunk and hip control. The SNF consult notes also indicated that she does not have sufficient motor neuron recovered to give significant gains in functional mobility. Physical therapy in ongoing. Medications in the SNF included. Subcutaneous Heparin, Tylenol, Nevacor (Lovastatin), Prilosec (omeprazole), Quinine sulfate, Elavil (amitriptyline), Fentanyl patch, Dilaudid, Ativan (alprazolam), Colace (docusate sodium), Senna, Dulcolax (bisacodyl), milk of magnesia, oil enema, Nasarel and artificial tears. The patient has not yet recovered. The reporter has assessed this event as not related to FluMist.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Laboratory test abnormal, Lipase increased, Monocytosis, Movement disorder, Musculoskeletal stiffness
Clinical narrative: Post Marketing Evaluation of the Safety of Influenza Virus vaccine live intranasal FluMist in healthy children and healthy adults 5 through 49 years of age. This is a 43 year old female who received FluMist on 11/14/05 and was diagnosed with Guillain Barre syndrome. On 1/26/06 at approximately 2am, the patient woke up and walked to the bathroom. She reported having difficulty using her right hand and almost fell down while she was walking to the toilet. She was seen at a hospital and was found to have a low potassium level of 2.8 which was repleted to 3.2. She also complained of a headache and neck stiffness, head CT was negative and a lumbar puncture was negative aside from and elevated CSF protein of 67. She was discharged home. A week prior to this event, she complained of flu like illness. At home, she was unable to walk and became almost quadriplegic. She was then brought to the emergency room. In the ER, neurology was consulted and an EMG was done with findings that were was strongly suggestive of Guillain Barre syndrome. She was then given Dilaudid 1mg IV and intravenous immunoglobulin IVIG was started at 400mg KG day to complete a total of 5 days. Other treatment include plasmapheresis. During the course of her hospitalization, she was also diagnosed with depression and was placed on Prozac (Fluoxetine). She was discharged after 31 days to a skilled nursing facility. In the SNF, Dilaudid was continued for pain management together with Fentanyl patch. As of 4/18/06, the rehabilitation notes indicated that the patient remains dependent on all activities of daily living although she continues to show increased strength for trunk and hip control. The SNF consult notes also indicated that she does not have sufficient motor neuron recovered to give significant gains in functional mobility. Physical therapy in ongoing. Medications in the SNF included. Subcutaneous Heparin, Tylenol, Nevacor (Lovastatin), Prilosec (omeprazole), Quinine sulfate, Elavil (amitriptyline), Fentanyl patch, Dilaudid, Ativan (alprazolam), Colace (docusate sodium), Senna, Dulcolax (bisacodyl), milk of magnesia, oil enema, Nasarel and artificial tears. The patient has not yet recovered. The reporter has assessed this event as not related to FluMist.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Neutropenia, Pain, Platelet disorder, Quadriplegia, Red blood cell abnormality
Clinical narrative: Post Marketing Evaluation of the Safety of Influenza Virus vaccine live intranasal FluMist in healthy children and healthy adults 5 through 49 years of age. This is a 43 year old female who received FluMist on 11/14/05 and was diagnosed with Guillain Barre syndrome. On 1/26/06 at approximately 2am, the patient woke up and walked to the bathroom. She reported having difficulty using her right hand and almost fell down while she was walking to the toilet. She was seen at a hospital and was found to have a low potassium level of 2.8 which was repleted to 3.2. She also complained of a headache and neck stiffness, head CT was negative and a lumbar puncture was negative aside from and elevated CSF protein of 67. She was discharged home. A week prior to this event, she complained of flu like illness. At home, she was unable to walk and became almost quadriplegic. She was then brought to the emergency room. In the ER, neurology was consulted and an EMG was done with findings that were was strongly suggestive of Guillain Barre syndrome. She was then given Dilaudid 1mg IV and intravenous immunoglobulin IVIG was started at 400mg KG day to complete a total of 5 days. Other treatment include plasmapheresis. During the course of her hospitalization, she was also diagnosed with depression and was placed on Prozac (Fluoxetine). She was discharged after 31 days to a skilled nursing facility. In the SNF, Dilaudid was continued for pain management together with Fentanyl patch. As of 4/18/06, the rehabilitation notes indicated that the patient remains dependent on all activities of daily living although she continues to show increased strength for trunk and hip control. The SNF consult notes also indicated that she does not have sufficient motor neuron recovered to give significant gains in functional mobility. Physical therapy in ongoing. Medications in the SNF included. Subcutaneous Heparin, Tylenol, Nevacor (Lovastatin), Prilosec (omeprazole), Quinine sulfate, Elavil (amitriptyline), Fentanyl patch, Dilaudid, Ativan (alprazolam), Colace (docusate sodium), Senna, Dulcolax (bisacodyl), milk of magnesia, oil enema, Nasarel and artificial tears. The patient has not yet recovered. The reporter has assessed this event as not related to FluMist.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: White blood cell disorder
Clinical narrative: Post Marketing Evaluation of the Safety of Influenza Virus vaccine live intranasal FluMist in healthy children and healthy adults 5 through 49 years of age. This is a 43 year old female who received FluMist on 11/14/05 and was diagnosed with Guillain Barre syndrome. On 1/26/06 at approximately 2am, the patient woke up and walked to the bathroom. She reported having difficulty using her right hand and almost fell down while she was walking to the toilet. She was seen at a hospital and was found to have a low potassium level of 2.8 which was repleted to 3.2. She also complained of a headache and neck stiffness, head CT was negative and a lumbar puncture was negative aside from and elevated CSF protein of 67. She was discharged home. A week prior to this event, she complained of flu like illness. At home, she was unable to walk and became almost quadriplegic. She was then brought to the emergency room. In the ER, neurology was consulted and an EMG was done with findings that were was strongly suggestive of Guillain Barre syndrome. She was then given Dilaudid 1mg IV and intravenous immunoglobulin IVIG was started at 400mg KG day to complete a total of 5 days. Other treatment include plasmapheresis. During the course of her hospitalization, she was also diagnosed with depression and was placed on Prozac (Fluoxetine). She was discharged after 31 days to a skilled nursing facility. In the SNF, Dilaudid was continued for pain management together with Fentanyl patch. As of 4/18/06, the rehabilitation notes indicated that the patient remains dependent on all activities of daily living although she continues to show increased strength for trunk and hip control. The SNF consult notes also indicated that she does not have sufficient motor neuron recovered to give significant gains in functional mobility. Physical therapy in ongoing. Medications in the SNF included. Subcutaneous Heparin, Tylenol, Nevacor (Lovastatin), Prilosec (omeprazole), Quinine sulfate, Elavil (amitriptyline), Fentanyl patch, Dilaudid, Ativan (alprazolam), Colace (docusate sodium), Senna, Dulcolax (bisacodyl), milk of magnesia, oil enema, Nasarel and artificial tears. The patient has not yet recovered. The reporter has assessed this event as not related to FluMist.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Road traffic accident, Syncope
Clinical narrative: Initial case received from a health care provider on 5/3/2006. An 18 year old male patient, with no past medical history, had received an injection of Menactra, lot number U1662AA and Tubersol 5 TU, lot number C2214AB, on 5/2/2006. Routes and sites of administration were not reported. Upon driving home post vaccination, the patient fainted and had a car accident. Per the reporter, no further details available at this time. At the time of this report, the patients recovery status was unknown.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Skin ulcer
Clinical narrative: A 20 year old male presents for take check of smallpox vaccination. Pt initially vaccinated on 3/31. F/u for take check 4/10. Revaccination was needed. Pt was revaccinated 4/28, 15 jabs. Pt came in today with disseminated lesions on left ant arm. No fever or other systemic illness. Pt does have erythema 1 inch at site. Streaking down for period of 2 weeks or only lesions ///. Instructions to go to ER. Temperature 101.
Age: 9.0
Sex: M
Vaccine: HEP, TDAP, VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Seen in office 5/6/06 with herpes zoster.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Bacterial infection, Pharyngitis
Clinical narrative: Diagnosed with strep pharyngitis 2 days after IPV given.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Mild edema with induration, mild erythema, non-tender to palpation.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: 5/4/06 10:00, Rt deltoid red, edematous, warm and tender to touch. Rt deltoid is the site of DTAP No 5. Mom states he had a slight fever last night. Describes him as being "cranky" and clingy. Otherwise, he was smiling, personable and active. Instructed to put ice on it, administer Tylenol or ibuprofen PRN, and continue to monitor. If no improvement/resolution in several days-call again.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Pyrexia
Clinical narrative: 5/4/06 10:00, Rt deltoid red, edematous, warm and tender to touch. Rt deltoid is the site of DTAP No 5. Mom states he had a slight fever last night. Describes him as being "cranky" and clingy. Otherwise, he was smiling, personable and active. Instructed to put ice on it, administer Tylenol or ibuprofen PRN, and continue to monitor. If no improvement/resolution in several days-call again.
Age: 1.3
Sex: M
Vaccine: DTAP, HBHEPB, HEPA
Symptoms: Cough, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: Fever up to 103 (R) for 2-3 days. He has also had cold symptoms (runny nose, congestion and cough). Treated only with Tylenol and ibuprofen.
Age: 1.07
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Rash papular
Clinical narrative: Multiple papules, vesicles
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Rash
Clinical narrative: Severe rash, trouble breathing
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pyrexia, Rash, Rash vesicular
Clinical narrative: Rash began as red spots on face 3/27/06 and then became vesicular. On 3/28/06 rash on arms and chest. Low grade temperature present. Using Benadryl PO for itching.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 2 weeks after having had an MMR, Pt developed a painful 3cm area of induration with surrounding erythema to the injection site. MMR was given on 4/17/06. Pt seen today 5/9/06 for first time since MMR was given. Placed on Cephalexin 500 MD QIB.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site mass, Injection site oedema, Type III immune complex mediated reaction
Clinical narrative: Noted swelling and redness with firmness at site which has increased from Quarter size to 12 x 16cm. DX'd as Arthus vs Cellulitis. Placed on Augmentin.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema, Injection site rash
Clinical narrative: Rash and swelling on injection site.
Age: 1.09
Sex: F
Vaccine: HBHEPB, MMR, PNC
Symptoms: Hypotonia
Clinical narrative: Sudden onset of hypotonia 2 days after vaccination. CT scan, CSF, tox screen and history negative. Botulinum toxin pending. Received in 2-3 days.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Swelling, redness started 5/12/06on left deltoid region. No fever.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site warmth
Clinical narrative: Redness, induration 2x1 1/2 cm to left outer aspect of upper left arm and warm to touch. No treatment prescribed other then Benadryl OTC.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Viral infection
Clinical narrative: 11 days after Varivax pt broke out in chicken pox however, chicken pox outbreak was present in community.
Age: 33.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Rash
Clinical narrative: Pt developed mild vaccine rash on arms, chest and back.
Age: 24.0
Sex: M
Vaccine: RAB
Symptoms: Injection site pain, Nausea, Vomiting
Clinical narrative: Left arm soreness 1/2 hours after receiving injection along with nausea and vomiting. Started he felt nauseated for the rest of the day and went to bed early. Felt better the next morning.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Tenderness
Clinical narrative: Modest swelling left arm dependent from site of vaccine left arm dependent from site of vaccine. Today (4 days out) 6x6 cm with moderate redness, tenderness.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Discomfort, Hypoaesthesia, Injection site pain, Pain
Clinical narrative: Problems in left arm. Pain in arm and shoulder up to neck and down to elbow. Felt like numbness, arm sleep. Continue to have discomfort, sharp pain in arm, arm still feels sleep. Took extra strength Tylenol for pain.
Age: 1.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Developed mild case of varicella
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Facial palsy
Clinical narrative: Patient developed Bell's Palsy on 4/29/2006.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Left deltoid area with extending erythema, warmth, pain and induration with decreased range of movement left arm, left cellulitis.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Joint range of motion decreased
Clinical narrative: Left deltoid area with extending erythema, warmth, pain and induration with decreased range of movement left arm, left cellulitis.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Several hours after vaccine was administered, pt developed a red indurated rectangular area that was tender to touch at the site of the injection.  Patient called office and MD instructed her to watch for worsening factors (i.e. fever), use Benadryl prn, Hydrocortisone cream prn, and ice.  Instructed pt that symptoms should subside in a few days and that it is most likely an allergic reaction and not to get the pneumovax in the future.
Age: 37.0
Sex: F
Vaccine: MMR, TD
Symptoms: Contusion, Erythema, Feeling hot, Hypoaesthesia, Oedema
Clinical narrative: 3/29-YESTERDAY MORNING, WOKE UP ARM WAS RED, SWOLLEN, WARM TO THE TOUCH, BRUISED WITH PAIN, NUMB TODAY.
Age: 37.0
Sex: F
Vaccine: MMR, TD
Symptoms: Pain
Clinical narrative: 3/29-YESTERDAY MORNING, WOKE UP ARM WAS RED, SWOLLEN, WARM TO THE TOUCH, BRUISED WITH PAIN, NUMB TODAY.
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Convulsion
Clinical narrative: MOTHER STATED, "PT HAD 2 SEIZURES THE NIGHT SHE RECEIVED TD SHOT."
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site vesicles, Injection site warmth
Clinical narrative: SWELLING, ERYTHEMA TO UPPER LEFT ARM, 10 CM, WARM TO TOUCH. 10 FLUID FILLED VESTICLES AT LOWER AREA OF SWELLING. ERYTHEMIA STARTED AFTER 24 HOURS, VESTICLES NOTICED APPROXIMATELY 36 HOURS LATER. NO GENERALIZED FEVER, NO ITCHING AT TIME OF REPORT. MOTHER STATES CHILD EXHIBITING USUAL ACTIVE BEHAVIOR. NO DISTRESS OR MALAISE. REFERRED TO CHILDS PHYSICIAN.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction, Injection site vesicles
Clinical narrative: LEFT UPPER ARM SWOLLEN WITH ERYTHEMA/TENDERNESS, VESICLE AT POLIO INJECTION SITE, WHEAL AT MMR INJECTION SITE, MOTHER ADVISED TO GIVE IBUPROPHEN EVERY 6 HOURS AND USE COLD PACK FOR 20 MINUTES.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: LEFT UPPER ARM SWOLLEN WITH ERYTHEMA/TENDERNESS, VESICLE AT POLIO INJECTION SITE, WHEAL AT MMR INJECTION SITE, MOTHER ADVISED TO GIVE IBUPROPHEN EVERY 6 HOURS AND USE COLD PACK FOR 20 MINUTES.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Received DTAP on Tuesday, went to school the next morning with an area of induration the size of a mosquito bite, by 5 pm most of L upper arm red swollen. used cold packs and Ibuprofen but area but it continued to swell and was seen in ER at 7:30 pm by PA who states arm was edematous and red from shoulder to elbow. Pt was able to move arm without problem but complained of pain and tenderness. He was seen at HD again on 5-11-06 and area remained tender and swollen from shoulder to elbow. 5-12-06 PHONE CALL to mom states area is not as red but is still swollen and has spread alittle more.
Age: 21.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Face oedema, Pruritus, Urticaria
Clinical narrative: Now at 48 hours /Symptoms began at 12 hours after shot. Reported/visited doctor. No treatment. Swollen lips/hives on hands, knees, ankles. Itch at these sites and also feet. Pain at vaccine site. Symptoms continue. Administered Benadryl. NOTE: Patient has known sulfa allergy. Drug (ADACEL) processed with products that could cause reaction/not known at initial visit...researched after visit.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Rash erythematous
Clinical narrative: Pt presented at ER with red raised bumps generalized in the trunk area and a few on the arms and legs.  Pt stated he "popped" some of them this morning.  Rash started about 0900 on 14 May 06.  Pt was sent home until follow-up appointment on 16 May 06.  Pt was instructed to limit contact with others.
Age: 0.33
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTP, HBHEPB, IPV, PNC, RV5
Symptoms: Purpura, Rash generalised, Rhinorrhoea, Roseola, Teething
Clinical narrative: Information has been received from a mother concerning her 17 week old son who had a history of gastroenteritis (approximately 2/18/2006 to 3/1/2006) but no other pertinent medical history or allergies who on 3/17/2006 was vaccinated PO with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). Suspected vaccinations administered on that same day included a dose of diphtheria toxoid + pertussis vaccine unspecified + tetanus toxoid, a dose of Pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR), a dose of hepatitis B virus vaccine rHBsAg yeast + Hib conj vaccine OMPC and a dose of poliovirus vaccine inactivated unspecified. The mother reported that on 3/18/2006, her son developed a rash on his legs. The rash was characterized by red, nickel size blotches. The mother described the hives as light pink in the center, dark pink on the outside and all different sizes and shapes. The patient went to the ER, but was not admitted to the hospital. No laboratory/diagnostic test were performed. Since the time of onset, the rash had spread to the rest of the patients body. It was noted that diphenhydramine HCL Benadryl cleared the rash for the first few days, but was not effective after that. At the time of this report, the patients rash persisted. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTP, HBHEPB, IPV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Information has been received from a mother concerning her 17 week old son who had a history of gastroenteritis (approximately 2/18/2006 to 3/1/2006) but no other pertinent medical history or allergies who on 3/17/2006 was vaccinated PO with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). Suspected vaccinations administered on that same day included a dose of diphtheria toxoid + pertussis vaccine unspecified + tetanus toxoid, a dose of Pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR), a dose of hepatitis B virus vaccine rHBsAg yeast + Hib conj vaccine OMPC and a dose of poliovirus vaccine inactivated unspecified. The mother reported that on 3/18/2006, her son developed a rash on his legs. The rash was characterized by red, nickel size blotches. The mother described the hives as light pink in the center, dark pink on the outside and all different sizes and shapes. The patient went to the ER, but was not admitted to the hospital. No laboratory/diagnostic test were performed. Since the time of onset, the rash had spread to the rest of the patients body. It was noted that diphenhydramine HCL Benadryl cleared the rash for the first few days, but was not effective after that. At the time of this report, the patients rash persisted. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTP, HBHEPB, IPV, PNC, RV5
Symptoms: Erythema, Rash, Rash macular, Urticaria
Clinical narrative: Information has been received from a mother concerning her 17 week old son who had a history of gastroenteritis (approximately 2/18/2006 to 3/1/2006) but no other pertinent medical history or allergies who on 3/17/2006 was vaccinated PO with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). Suspected vaccinations administered on that same day included a dose of diphtheria toxoid + pertussis vaccine unspecified + tetanus toxoid, a dose of Pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR), a dose of hepatitis B virus vaccine rHBsAg yeast + Hib conj vaccine OMPC and a dose of poliovirus vaccine inactivated unspecified. The mother reported that on 3/18/2006, her son developed a rash on his legs. The rash was characterized by red, nickel size blotches. The mother described the hives as light pink in the center, dark pink on the outside and all different sizes and shapes. The patient went to the ER, but was not admitted to the hospital. No laboratory/diagnostic test were performed. Since the time of onset, the rash had spread to the rest of the patients body. It was noted that diphenhydramine HCL Benadryl cleared the rash for the first few days, but was not effective after that. At the time of this report, the patients rash persisted. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Unintended pregnancy
Clinical narrative: Information has been received through the pregnancy registry from a physician concerning a 35 year old female who on 6/1/2005 was vaccinated with a dose of varicella virus vaccine live (lot 648933/0827P). It was reported that the patient was definitely pregnant, with an LMP of 5/15/2005. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information received from a physician indicated that the patient was tested for varicella antibodies before vaccination, and the results were negative. It was noted that she had one previous pregnancy. No birth defects occurred in any previous pregnancy. No stillbirth or miscarriage occurred in any previous pregnancy. There was no local reaction at the vaccination site. There were no varicella or herpes zoster symptoms post vaccination. The reporter indicated that the patient lost the pregnancy in the first trimester. Upon internal review, the loss of pregnancy was considered to be an other important medical event (OMIC). No additional information is expected.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Abdominal pain, Diarrhoea, Dyspnoea, Feeling hot, Hypokinesia
Clinical narrative: From initial information received on 02May06 from a literature report. It was reported that a four year old male pt who had missed his previous Dtap booster vaccination at 12-18 months of age had received his fourth dose of a 3 component acellular pertussis vaccine combined with diphtheria and tetanus toxoids (Dtap) into the right thigh, and a measles mumps rubella vaccine injection into the left thigh. Manf, routes and lot numbers were not reported for either vaccine. 12 hrs post immunization, he presented to the ER room with diffuse swelling and erythema of the right thigh. The erythema and swelling progressed to involve the entire right thigh with mild pain noted around the Dtap injection site. No other systemic reactions such as fever, nausea, vomiting, diarrhea, abdominal pain or dyspnea were noted. Physical examination in the ER revealed a well appearing child in no acute distress. The right anterior thigh was markedly erythematous, warm to touch and mildly painful with movement. An erythematous papule surrounded by an area of pallor marked the injection site of the Dtap vaccine. The remainder of the physical examination was normal. Lab studies showed a white blood cell count of 8700/mm3 a platelet count of 118,000/mm3 and a negative blood culture. Because of concern for infection, therapy with intravenous oxacillin was initiated. Over the course of several hours, area became increasingly pruritic and diphenhydramine was administered. A contrasted computed tomography scan of both thighs revealed extensive edema and soft tissue swelling of the right anterior thigh. The thickness of the soft tissues between the anterior surface of the thigh and the patella on the right was 1.10cm and that on the left was 0.43cm. The thickness of the muscles in the right thigh was 6.92cm, and that on the left was 6.64cm. No evidence of abscess or bone abnormalities was seen. A venous Doppler study of both lower extremities demonstrated no evidence of deep venous thrombosis. During the hospitalization, the child remained afebrile and playful, with normal appetite and normal leg mobility. The reaction resolved completely by the end of the second hospital day, and the child was discharged.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Infection, Injection site erythema, Injection site oedema, Injection site pain, Nausea
Clinical narrative: From initial information received on 02May06 from a literature report. It was reported that a four year old male pt who had missed his previous Dtap booster vaccination at 12-18 months of age had received his fourth dose of a 3 component acellular pertussis vaccine combined with diphtheria and tetanus toxoids (Dtap) into the right thigh, and a measles mumps rubella vaccine injection into the left thigh. Manf, routes and lot numbers were not reported for either vaccine. 12 hrs post immunization, he presented to the ER room with diffuse swelling and erythema of the right thigh. The erythema and swelling progressed to involve the entire right thigh with mild pain noted around the Dtap injection site. No other systemic reactions such as fever, nausea, vomiting, diarrhea, abdominal pain or dyspnea were noted. Physical examination in the ER revealed a well appearing child in no acute distress. The right anterior thigh was markedly erythematous, warm to touch and mildly painful with movement. An erythematous papule surrounded by an area of pallor marked the injection site of the Dtap vaccine. The remainder of the physical examination was normal. Lab studies showed a white blood cell count of 8700/mm3 a platelet count of 118,000/mm3 and a negative blood culture. Because of concern for infection, therapy with intravenous oxacillin was initiated. Over the course of several hours, area became increasingly pruritic and diphenhydramine was administered. A contrasted computed tomography scan of both thighs revealed extensive edema and soft tissue swelling of the right anterior thigh. The thickness of the soft tissues between the anterior surface of the thigh and the patella on the right was 1.10cm and that on the left was 0.43cm. The thickness of the muscles in the right thigh was 6.92cm, and that on the left was 6.64cm. No evidence of abscess or bone abnormalities was seen. A venous Doppler study of both lower extremities demonstrated no evidence of deep venous thrombosis. During the hospitalization, the child remained afebrile and playful, with normal appetite and normal leg mobility. The reaction resolved completely by the end of the second hospital day, and the child was discharged.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Pain, Pallor, Platelet disorder, Pruritus, Pyrexia
Clinical narrative: From initial information received on 02May06 from a literature report. It was reported that a four year old male pt who had missed his previous Dtap booster vaccination at 12-18 months of age had received his fourth dose of a 3 component acellular pertussis vaccine combined with diphtheria and tetanus toxoids (Dtap) into the right thigh, and a measles mumps rubella vaccine injection into the left thigh. Manf, routes and lot numbers were not reported for either vaccine. 12 hrs post immunization, he presented to the ER room with diffuse swelling and erythema of the right thigh. The erythema and swelling progressed to involve the entire right thigh with mild pain noted around the Dtap injection site. No other systemic reactions such as fever, nausea, vomiting, diarrhea, abdominal pain or dyspnea were noted. Physical examination in the ER revealed a well appearing child in no acute distress. The right anterior thigh was markedly erythematous, warm to touch and mildly painful with movement. An erythematous papule surrounded by an area of pallor marked the injection site of the Dtap vaccine. The remainder of the physical examination was normal. Lab studies showed a white blood cell count of 8700/mm3 a platelet count of 118,000/mm3 and a negative blood culture. Because of concern for infection, therapy with intravenous oxacillin was initiated. Over the course of several hours, area became increasingly pruritic and diphenhydramine was administered. A contrasted computed tomography scan of both thighs revealed extensive edema and soft tissue swelling of the right anterior thigh. The thickness of the soft tissues between the anterior surface of the thigh and the patella on the right was 1.10cm and that on the left was 0.43cm. The thickness of the muscles in the right thigh was 6.92cm, and that on the left was 6.64cm. No evidence of abscess or bone abnormalities was seen. A venous Doppler study of both lower extremities demonstrated no evidence of deep venous thrombosis. During the hospitalization, the child remained afebrile and playful, with normal appetite and normal leg mobility. The reaction resolved completely by the end of the second hospital day, and the child was discharged.