chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Areflexia, Guillain-Barre syndrome, IIIrd nerve paresis, Miller Fisher syndrome
Clinical narrative: Initial and follow up information has been received from a registered nurse, concerning a 19 year old female patient with a history of left sided Bell's palsy (year unknown), who on 25-JUL-2007 was vaccinated with the first dose of Gardasil (lot # 658100/0525U). Concomitant therapy included birth control pills (unspecified manufacturer). On approximately 17-DEC-2007, the patient "developed symptoms" and on 31-DEC-2007 she was hospitalized with "probable Miller-Fisher variant of Guillain Barre syndrome." Her symptoms included ophthalmoparesis and areflexia with stocking-glove distribution. Treatment included immunoglobulin, IgG. On 01-JAN-2008 (previously reported as 07-JAN-2008), the patient was discharged from the hospital. The nurse indicated the patient had a follow up visit scheduled with a neurologist on 07-JAN-2008, though she had no knowledge of the results or findings from the visit. The nurse mentioned that the patient had not received subsequent doses of Gardasil, due to concern about the administration of IgG while in the hospital. At the time of this report, the outcome of the event was unknown. Additional information has been requested.  1/25/08 Follow up initiated at request of CDC.  1/25/08 Received vax record which reveals patient received Menactra U2380BA & Gardisil 0525U on 7/25/07.  Admitted to hospital 12/31/07 after outpatient vs to neurologist.  Numbness & tingling in hand started approx 2 wks prior & spread to left arm.  Developed difficulty focusing, eye pain & numbness in both feet.  Exam revealed ophthalmoparesis, areflexia & stocking/glove sensory disturbance.  MRI of brain reviewed which was WNL.  Nerve conduction studies done which was abnormal. Neuro hospital admit dx: probable Miller Fisher variant of Guillain-Barre syndrome. 2/5/08 Reviewed hospital medical records which reveal patient experienced numbness & tingling of hand & feet, difficulty focusing & eye pain starting approx 12/16/2007.  On admit had limited extraocular movements w/left lateral gaze nystagmus, dysmetria on finger-to-nose on left & unsteady gait.  Admitted 12/31/07-1/2/2008.  Tx w/IVIG x 3 days w/noted improvement.  Developed HA w/IVIG tx.  D/C to home & f/u w/neurologist. FINAL DX: Miller-Fisher variant Guillain-Barre syndrome.  2/8/08 Reviewed neurologist med records which reveal patient seen 12/31/07.  Pt had 2 wk hx of progressive numbness & paresthesias in bilat hand/feet which started w/left hand, as well as difficulty w/eye movements.  F/U visit 1/7/08 revealed pt had HA, left eye shaking, numbness/tingling of hand/feet improving but still present. FINAL Neuro DX: probable Miller Fisher variant of Guillain-Barre syndrome.
Sex: M
Vaccine: VARZOS
Symptoms: Antinuclear antibody positive, Asthenia, Coombs direct test positive, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Information has been received from a consumer (retired nurse) concerning her male husband with heart disease, hypertension, kidney stones and an allergy to Septra and a history of cardiac artery bypass graft surgery, lumbar laminectomy and cholecystectomy who on 24-Oct-2007 was vaccinated with "1 injection" dose of Zostavax.  Concomitant therapy included atenolol (manufacturer unknown), allopurinol (manufacturer unknown). lorazepam, simvastatin (manufacturer unknown), aspirin, omeprazole (Prilosec), folic acid, ondansetron hydrochloride (Zofran), gastrointestinal preparations (stool softeners) (unspecified), nitroglycerin, ibuprofen (Advil) and zolpidem tartrate (Ambien CR).  On 28-Nov-2007, post vaccination, the patient developed hemolytic anemia.  The following are a list of the patient's hemoglobins (Hgb) and hematocrits (Hct) reported:  10-Jan-2007 Hgb - 12.2 and Hct - 40.4.  On 05-May-2007 Hgb - 13.6 and Hct - 43.0.  On 31-Oct-2007 the patient went to the physician for "some type of complaint".  Hgb - 10.2 and Hct - 35.0.  On 28-Nov-2007 Hgb - 9.9 and Hct (unknown).  The patient complained of "extreme weakness and having to use great effort even to do personal hygiene".  The patient was started on prednisone 30mg twice a day.  On 07-Dec-2007 the patient's Hgb - 9.1 and Hct - 31.0.  Per the reporter the patient's physician requested to see the patient in his office.  Additional labs were performed.  Antinuclear antibody test, rheumatoid factor, COOMBs test and sedimentation rate were all positive.  A heme test of the stool was negative.  It was reported the physician stated "there is some problem with his immune system".  On 03-Jan-2008 Hgb - 11.9 and Hct - 39.0.  The patient also saw a hematologist.  Additional lab work was performed and the results are pending.  The patient is currently tapering the prednisone dose as follows:  Pednisone 30 mg twice a day for 1 week, the 40 mg twice a day for 1 week, then 40 mg in the am and 20 mg in the pm for 1 week, then 20 mg in the am and 20 mg in the pm for 1 week.  The patient is currently taking 20 mg in the am and nothing in the pm for 1 week and then will discontinue prednisone.  A few days after starting prednisone the nurse reported her husband began to feel better again but since he started to taper the prednisone he has reported less energy.  At the time of the report the patient's status was recovering.  A product quality complaint was not involved.  The adverse events reported were considered to be disabling.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Haemolytic anaemia, Immune system disorder, Red blood cell abnormality, Red blood cell sedimentation rate increased, Rheumatoid factor positive
Clinical narrative: Information has been received from a consumer (retired nurse) concerning her male husband with heart disease, hypertension, kidney stones and an allergy to Septra and a history of cardiac artery bypass graft surgery, lumbar laminectomy and cholecystectomy who on 24-Oct-2007 was vaccinated with "1 injection" dose of Zostavax.  Concomitant therapy included atenolol (manufacturer unknown), allopurinol (manufacturer unknown). lorazepam, simvastatin (manufacturer unknown), aspirin, omeprazole (Prilosec), folic acid, ondansetron hydrochloride (Zofran), gastrointestinal preparations (stool softeners) (unspecified), nitroglycerin, ibuprofen (Advil) and zolpidem tartrate (Ambien CR).  On 28-Nov-2007, post vaccination, the patient developed hemolytic anemia.  The following are a list of the patient's hemoglobins (Hgb) and hematocrits (Hct) reported:  10-Jan-2007 Hgb - 12.2 and Hct - 40.4.  On 05-May-2007 Hgb - 13.6 and Hct - 43.0.  On 31-Oct-2007 the patient went to the physician for "some type of complaint".  Hgb - 10.2 and Hct - 35.0.  On 28-Nov-2007 Hgb - 9.9 and Hct (unknown).  The patient complained of "extreme weakness and having to use great effort even to do personal hygiene".  The patient was started on prednisone 30mg twice a day.  On 07-Dec-2007 the patient's Hgb - 9.1 and Hct - 31.0.  Per the reporter the patient's physician requested to see the patient in his office.  Additional labs were performed.  Antinuclear antibody test, rheumatoid factor, COOMBs test and sedimentation rate were all positive.  A heme test of the stool was negative.  It was reported the physician stated "there is some problem with his immune system".  On 03-Jan-2008 Hgb - 11.9 and Hct - 39.0.  The patient also saw a hematologist.  Additional lab work was performed and the results are pending.  The patient is currently tapering the prednisone dose as follows:  Pednisone 30 mg twice a day for 1 week, the 40 mg twice a day for 1 week, then 40 mg in the am and 20 mg in the pm for 1 week, then 20 mg in the am and 20 mg in the pm for 1 week.  The patient is currently taking 20 mg in the am and nothing in the pm for 1 week and then will discontinue prednisone.  A few days after starting prednisone the nurse reported her husband began to feel better again but since he started to taper the prednisone he has reported less energy.  At the time of the report the patient's status was recovering.  A product quality complaint was not involved.  The adverse events reported were considered to be disabling.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Stool analysis normal
Clinical narrative: Information has been received from a consumer (retired nurse) concerning her male husband with heart disease, hypertension, kidney stones and an allergy to Septra and a history of cardiac artery bypass graft surgery, lumbar laminectomy and cholecystectomy who on 24-Oct-2007 was vaccinated with "1 injection" dose of Zostavax.  Concomitant therapy included atenolol (manufacturer unknown), allopurinol (manufacturer unknown). lorazepam, simvastatin (manufacturer unknown), aspirin, omeprazole (Prilosec), folic acid, ondansetron hydrochloride (Zofran), gastrointestinal preparations (stool softeners) (unspecified), nitroglycerin, ibuprofen (Advil) and zolpidem tartrate (Ambien CR).  On 28-Nov-2007, post vaccination, the patient developed hemolytic anemia.  The following are a list of the patient's hemoglobins (Hgb) and hematocrits (Hct) reported:  10-Jan-2007 Hgb - 12.2 and Hct - 40.4.  On 05-May-2007 Hgb - 13.6 and Hct - 43.0.  On 31-Oct-2007 the patient went to the physician for "some type of complaint".  Hgb - 10.2 and Hct - 35.0.  On 28-Nov-2007 Hgb - 9.9 and Hct (unknown).  The patient complained of "extreme weakness and having to use great effort even to do personal hygiene".  The patient was started on prednisone 30mg twice a day.  On 07-Dec-2007 the patient's Hgb - 9.1 and Hct - 31.0.  Per the reporter the patient's physician requested to see the patient in his office.  Additional labs were performed.  Antinuclear antibody test, rheumatoid factor, COOMBs test and sedimentation rate were all positive.  A heme test of the stool was negative.  It was reported the physician stated "there is some problem with his immune system".  On 03-Jan-2008 Hgb - 11.9 and Hct - 39.0.  The patient also saw a hematologist.  Additional lab work was performed and the results are pending.  The patient is currently tapering the prednisone dose as follows:  Pednisone 30 mg twice a day for 1 week, the 40 mg twice a day for 1 week, then 40 mg in the am and 20 mg in the pm for 1 week, then 20 mg in the am and 20 mg in the pm for 1 week.  The patient is currently taking 20 mg in the am and nothing in the pm for 1 week and then will discontinue prednisone.  A few days after starting prednisone the nurse reported her husband began to feel better again but since he started to taper the prednisone he has reported less energy.  At the time of the report the patient's status was recovering.  A product quality complaint was not involved.  The adverse events reported were considered to be disabling.  Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Pruritus, Rash
Clinical narrative: 12/21-Started getting occassional stabbing pains in upper right chest and -lasted 3 + weeks (no rash). 12/24-Chest pain and itch (no rash). 12-29-Chest Pain (occasional) and itch; soreness (no rash) hospitalized. 12-30- Hospitalized for stress test and rash 2-3" (on back only) present continued through 1/16/082/4/08-records received for DOS 12/29-12/30/07-DC DX: Very typical chest pain, doubt cardiac. Back dermatomal pain. Likely shingles.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: C-reactive protein, Complement factor C3, Complement factor C4, Complement factor normal, Contusion
Clinical narrative: Received Tdap 1/8/2008 to Left Deltoid IM. Approx 3 hr post vac passenger in car noted left upper arm muscle tightness with pain radiating down left arm (3-4/10), no site rx noted.  This persisted for next two days until day 3 she noted redness surrounding vac site @ 6cm. The next day (day 4) c/o nodule formation @ 4cm with redness 6cm and hot to touch. Still with pain now 10/10 like rt arm after breast surgery - worse with ROM. Denied any fever, numbness, tingling, weakness, coldness, axillary swelling, n/v. ROM triggered pain but could move. On Tylenol, Tramadol, Parafon forte, using ice to site w/some relief.   She called immun about day 4-5 and was advised wait 1 week as rx may resolve-to f/u if no better in clinic. She presented day 10 with continued s/s pain (4/10) on meds with resolving redness and nodule formation. Has noted small area bruising to inner lower upper arm by elbow with no known injury.  Felt sore spot washing 2 days ago when first seen.  C/o pain rotating left arm, lifting obj's, dressing self, and limited ROM arm due to pain..
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site nodule, Movement disorder, Muscle tightness
Clinical narrative: Received Tdap 1/8/2008 to Left Deltoid IM. Approx 3 hr post vac passenger in car noted left upper arm muscle tightness with pain radiating down left arm (3-4/10), no site rx noted.  This persisted for next two days until day 3 she noted redness surrounding vac site @ 6cm. The next day (day 4) c/o nodule formation @ 4cm with redness 6cm and hot to touch. Still with pain now 10/10 like rt arm after breast surgery - worse with ROM. Denied any fever, numbness, tingling, weakness, coldness, axillary swelling, n/v. ROM triggered pain but could move. On Tylenol, Tramadol, Parafon forte, using ice to site w/some relief.   She called immun about day 4-5 and was advised wait 1 week as rx may resolve-to f/u if no better in clinic. She presented day 10 with continued s/s pain (4/10) on meds with resolving redness and nodule formation. Has noted small area bruising to inner lower upper arm by elbow with no known injury.  Felt sore spot washing 2 days ago when first seen.  C/o pain rotating left arm, lifting obj's, dressing self, and limited ROM arm due to pain..
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Received Tdap 1/8/2008 to Left Deltoid IM. Approx 3 hr post vac passenger in car noted left upper arm muscle tightness with pain radiating down left arm (3-4/10), no site rx noted.  This persisted for next two days until day 3 she noted redness surrounding vac site @ 6cm. The next day (day 4) c/o nodule formation @ 4cm with redness 6cm and hot to touch. Still with pain now 10/10 like rt arm after breast surgery - worse with ROM. Denied any fever, numbness, tingling, weakness, coldness, axillary swelling, n/v. ROM triggered pain but could move. On Tylenol, Tramadol, Parafon forte, using ice to site w/some relief.   She called immun about day 4-5 and was advised wait 1 week as rx may resolve-to f/u if no better in clinic. She presented day 10 with continued s/s pain (4/10) on meds with resolving redness and nodule formation. Has noted small area bruising to inner lower upper arm by elbow with no known injury.  Felt sore spot washing 2 days ago when first seen.  C/o pain rotating left arm, lifting obj's, dressing self, and limited ROM arm due to pain..
Age: 1.1
Sex: M
Vaccine: HEPA, HIBV, MMRV
Symptoms: Erythema, Rash vesicular
Clinical narrative: Spontaneous eruption erythematous raised lesions with 5 cent vesicular centers - Appearing in crops and increasing (-) other symptoms
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Prickly heat type rash on right side of neck, shoulder and upper arm with about a dozen red round (not quite dime sized) welts. Itchy when touched. Also a small outbreak at small of back. Was not painful, just itchy. Lasted 4-5 days. I called doctor's office. They asked "Does it hurt?" I said no. They said probably not a problem but we're here if you need us. I did not go in.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: 10-20 Lesions
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, PPV
Symptoms: Inappropriate schedule of drug administration, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: DTaP and PCV 7 given on 12/5/07 Both in Rt thigh (HIB in Lt Leg)- Developed swelling/induration at site-favoring leg-appears painful to touch- no known fevers- parents used heat and cold-pt. seen 12/14- no longer favoring leg-still with some 1cm by 1 cm induration
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Contusion, Erythema, Induration, Swelling
Clinical narrative: Received flu vaccine on Thursday and had reaction. By later same day and into Fri am very firm, swollen and red. Area went from shot site down to knee and half way around thigh. MD diagnosed cellulitis and started Amoxil. Sat no better so started Cefdinir. Mon redness subsided swelling decreased and site remained bruised.
Age: 44.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Activities of daily living impaired, Cellulitis, Erythema, Pain in extremity, Sleep disorder
Clinical narrative: Severe arm pain radiating down arm. Swelling, redness, difficulty sleeping due to pain, can't exercise. Dx cellulitis per doctor visit.
Age: 44.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Swelling
Clinical narrative: Severe arm pain radiating down arm. Swelling, redness, difficulty sleeping due to pain, can't exercise. Dx cellulitis per doctor visit.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Client came in 1/16/08 with macular erythematous lesion on lower extremities, macular erythematous pinpoint lesions to bilateral arms and stomach - Patient received Hep B #2 on 1/14/08 - left deltoid - no redness or swelling noted at injection site - Client did just change soap - Diagnosed by APNP with Rash - treated with Benadryl - on 1/18/08 - Rash was gone
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Headache, Hypoaesthesia, Malaise
Clinical narrative: PAIN AND REDNESS IN RIGHT ARM APPROX. ONE HOUR AFTER GETTING PNEUMOCOCCAL VACCINE. ON 12-4-07. SHE ALSO HAD A HEADACHE, NAUSEA AND CHILLS THE NEXT DAY. SHE SAID SHE FELT "SICK ALL OVER". FEELS AS THOUGH HER ARM IS "ASLEEP" TAKING TYLENLOL, SAW PCP FOR A PRESCHEDULED APPT.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain in extremity
Clinical narrative: PAIN AND REDNESS IN RIGHT ARM APPROX. ONE HOUR AFTER GETTING PNEUMOCOCCAL VACCINE. ON 12-4-07. SHE ALSO HAD A HEADACHE, NAUSEA AND CHILLS THE NEXT DAY. SHE SAID SHE FELT "SICK ALL OVER". FEELS AS THOUGH HER ARM IS "ASLEEP" TAKING TYLENLOL, SAW PCP FOR A PRESCHEDULED APPT.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Dysphagia, Electromyogram abnormal, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Pt claims he received influenza vaccine at outside hospital 11/23. 11/25 he noted leg weakness and could not walk without assisstance.  He was admitted 11/27 with leg weakness, hand, feet and mouth numb, and difficulty swallowing.  Pt also developed respiratory failure.  Guillain Barre was diagnosed per EMG and nerve conduction studies and pt hospitalized 11/27/07-1/22/08. Pt transferred to outside rehabilitation facility. 2/20/08-records received for DOS 11/27/07-01/22/08-DC DX: Guillain Barre syndrome. Respiratory failure, ventilator associated pneumonia, ARDS. Atrial fibrillation with RVR. Acute renal failure. C-difficule diarrhea. Citrobacter UTI. Anemia. Bilateral lower extremity DVTs. Mild to moderate mixed hearing loss. Type two diabetes mellitus. Stage two decubitus ulcer. Neuropathic pain. Right middle lobe abscess. Two days after vaccination developed progressive bilateral lower extremity and bilateral upper extremity weakness and dificulty standing. Previous exploratory laparotomy for small bowel obstruction 11/07. Trached. Transferred to rehabilitation facility.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia oral, Muscular weakness, Nerve conduction studies abnormal, Respiratory failure
Clinical narrative: Pt claims he received influenza vaccine at outside hospital 11/23. 11/25 he noted leg weakness and could not walk without assisstance.  He was admitted 11/27 with leg weakness, hand, feet and mouth numb, and difficulty swallowing.  Pt also developed respiratory failure.  Guillain Barre was diagnosed per EMG and nerve conduction studies and pt hospitalized 11/27/07-1/22/08. Pt transferred to outside rehabilitation facility. 2/20/08-records received for DOS 11/27/07-01/22/08-DC DX: Guillain Barre syndrome. Respiratory failure, ventilator associated pneumonia, ARDS. Atrial fibrillation with RVR. Acute renal failure. C-difficule diarrhea. Citrobacter UTI. Anemia. Bilateral lower extremity DVTs. Mild to moderate mixed hearing loss. Type two diabetes mellitus. Stage two decubitus ulcer. Neuropathic pain. Right middle lobe abscess. Two days after vaccination developed progressive bilateral lower extremity and bilateral upper extremity weakness and dificulty standing. Previous exploratory laparotomy for small bowel obstruction 11/07. Trached. Transferred to rehabilitation facility.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain upper, Back pain, Insomnia, Malaise, Musculoskeletal pain
Clinical narrative: Patient received pneumonia vaccine on 1/21/08. Vaccine was from Merck, Lot # 1344U. Patient stated that 1-2 hours after his vaccine his left shoulder developed tolerable pain. About 6 hours later, the pain extended into his torso. He described it as an excrutiating, dull ache to 8/10, and kept him awake some of that night and reported a low grade fever to 99.5. The pain started subsiding the next morning, while also complaining of malaise. Per the patient, he had no other reasons for this torso pain.  Patient also reported back and stomach muscle pain as well.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Patient received pneumonia vaccine on 1/21/08. Vaccine was from Merck, Lot # 1344U. Patient stated that 1-2 hours after his vaccine his left shoulder developed tolerable pain. About 6 hours later, the pain extended into his torso. He described it as an excrutiating, dull ache to 8/10, and kept him awake some of that night and reported a low grade fever to 99.5. The pain started subsiding the next morning, while also complaining of malaise. Per the patient, he had no other reasons for this torso pain.  Patient also reported back and stomach muscle pain as well.
Age: 7.0
Sex: M
Vaccine: FLU3, HEPA, IPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site swelling and redness to the Upper Left Arm (back of arm). Ibuprofen was given to child by his parent along with using cool compresses to injection site. The injection was given at 10:45am.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Received 2nd flu vaccine dose when already received on 11/01/07.  No reaction noted.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Computerised tomogram, Electroencephalogram, Epilepsy, Nuclear magnetic resonance imaging brain
Clinical narrative: Pt. developed new onset epilepsy 3 months after second Gardasil dose.
Age: 60.0
Sex: F
Vaccine: HEPA, PPV, VARZOS
Symptoms: Ataxia, Erythema, Gait disturbance, Hypoaesthesia, Muscular weakness
Clinical narrative: Onset of red papular/fine vesicular rash on torso 8-10 days after receiving vaccines noted below. Subsequently developed itching and then numbness and pain in the torso from mid chest to lower abdomen. Also has some instability of gait (ataxia) with mild lower extremity weakness. Treated with Acyclovir, Gabapentin, narcotic analgesics and amitriptyline. Still has slight rash and moderate pain as of 1/24/2008.
Age: 60.0
Sex: F
Vaccine: HEPA, PPV, VARZOS
Symptoms: Pain, Pruritus, Rash papular
Clinical narrative: Onset of red papular/fine vesicular rash on torso 8-10 days after receiving vaccines noted below. Subsequently developed itching and then numbness and pain in the torso from mid chest to lower abdomen. Also has some instability of gait (ataxia) with mild lower extremity weakness. Treated with Acyclovir, Gabapentin, narcotic analgesics and amitriptyline. Still has slight rash and moderate pain as of 1/24/2008.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Extreme redness/swelling at injection site within 1 hour of receiving injection.
Age: 14.0
Sex: F
Vaccine: FLUX, MEN, TD
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: Patient went to Doctor for routine Physical Examination.  Approx. 5 minutes after given Gardasil Shot, patient lost consciousness.  During the loss of consciousness, her arms and legs seized up and her hands seized up at the wrists.  She was making a gurgling noise with her mouth and her head/neck were seizing, bringing her chin down to her chest.  After about 60 seconds, the nurses and doctor were able to revive her by leaning her forward and calling her name twice.  Patient is a very healthy female with no existing medical conditions and no family history of seizures or fainting spells.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swollen, red, warm to touch. Treated with Keflex, Motrin and warm compresses.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Medication error, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of wrong vaccine administered in a newborn subject less than one day old of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline) for prophylaxis. On 21 January 2008, the newborn subject inadvertently received an unspecified dose of Fluarix (unknown) instead of an intended Hepatitis B vaccine. This was considered to be a medication error, as Fluarix is not indicated for use in subjects under the age of 18 years. The newborn was hospitalized following birth and it was unclear at the time of reporting whether the medication error would prolong the subject's stay in the hospital. The reporting pharmacist stated that no patient chart was available, but no adverse events had occurred at the time of this report.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Borrelia burgdorferi serology negative, Facial palsy
Clinical narrative: (L) facial paralysis. 3/7/08-records received-1/9/08-C/O left side of face crooked when mouth is open. Seen in office on 1/10/08-Bell's Palsy. 1/17/08-left side mouth still swollen. 1/24/08-Bell's Palsy resolving.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Diarrhoea, Headache, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Headache, fever, sore throat, chills, diarrhea starting 48 hours after Gardasil vaccine was given.
Age: 0.8
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Welts coming and going all over body; next day and day after (today). Also had with 2nd set of immunizations at another provider 7-13-07 unknown to us.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: The patient was brought in for his 2 month well child visit which usually includes the first set of immunizations. There was no completed immunization record in the patients chart and the physician ordered the following vaccines to be given: DTAP, IPV, HIB/HEP B, PREVNAR and Rotovirus, The vaccines were given as ordered by this writer causing them to be duplicated.;No adverse reaction
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Asthenia, Chills, Headache, Hyperhidrosis, Pain
Clinical narrative: 1/19/8-Fevers, high of 103.2 degrees, chills, sore body, weak, headache.  1/20/8-Fevers, high of 103.4 degrees, chills, sore body, weak, headache.  1/21/8-Fevers, lower 101.8 degrees, sore body, chills, sweats.  1/22/8-Fevers, 101.7 degrees.  1/23/8-Lower fever in morning 100.9 degrees, went to hospital, ER in AM (fever for 5 days).  1/24/8-No fever in morning today.  Prescribed antibiotic at hospital.  Hospital Dr. believes he had bad reaction to shot first 2 days plus/or then a virus.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Pyrexia, Vaccination complication, Viral infection
Clinical narrative: 1/19/8-Fevers, high of 103.2 degrees, chills, sore body, weak, headache.  1/20/8-Fevers, high of 103.4 degrees, chills, sore body, weak, headache.  1/21/8-Fevers, lower 101.8 degrees, sore body, chills, sweats.  1/22/8-Fevers, 101.7 degrees.  1/23/8-Lower fever in morning 100.9 degrees, went to hospital, ER in AM (fever for 5 days).  1/24/8-No fever in morning today.  Prescribed antibiotic at hospital.  Hospital Dr. believes he had bad reaction to shot first 2 days plus/or then a virus.
Age: 1.1
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC
Symptoms: Wrong drug administered
Clinical narrative: No adverse seen, but pt was given IPV and Hep B by mistake.
Age: 27.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Chills, Cough, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Two days following vaccination patient experienced chills, cold sweat & fatigue.  Reports have a "fever".  Dizziness, congestion, diarrhea, runny nose, cough, SOB and headache.  Symptoms lasted 5 days and patient reports "feeling much better" on 1/24/08.
Age: 27.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Fatigue, Feeling cold, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Two days following vaccination patient experienced chills, cold sweat & fatigue.  Reports have a "fever".  Dizziness, congestion, diarrhea, runny nose, cough, SOB and headache.  Symptoms lasted 5 days and patient reports "feeling much better" on 1/24/08.
Age: 27.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Two days following vaccination patient experienced chills, cold sweat & fatigue.  Reports have a "fever".  Dizziness, congestion, diarrhea, runny nose, cough, SOB and headache.  Symptoms lasted 5 days and patient reports "feeling much better" on 1/24/08.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Haematoma
Clinical narrative: Had a dime size hematoma at injection site.  Arm turned blue immediately after shot.  Patient was given Benadryl and watched appropriately.  Doctor checked him and he was ok.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Blood potassium increased, Blood pressure increased, Decreased appetite, Diarrhoea, Gastrointestinal haemorrhage
Clinical narrative: Received vaccines on 11/9/07. Became ill with diarrhea and decreased appetite on 11/10/07. Symptoms continued throughout weekend with appetite continually decreasing and urine output declining. Encouraged Pedialyte and feeds often, gave Tylenol (though my son was afebrile) under direction of various oncall nurses and MD. Took son to Pediatrician Monday-physical exam only-sent home. Took son to ER early Tuesday a.m. Requesting labs as still no appetite, continued diarrhea and occasional vomiting. Labs showed HUS with acute kidney failure. Hgb of 5, K+ 7.8, blood pressure 190-200's systolic. Life flighted to Hospital. Surgery for placement of peritoneal dialysis catheter placed, continuing peritoneal dialysis initiated, intubated and on ventilator for 8 days, multiple surgeries for line and port placements and removals, EGD for diagnosis of GI bleed, 4 weeks stay in PICU and 1 week in Pediatrics. Continues to be followed by pediatric nephrologist and cardiologist.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Haemoglobin decreased, Haemolytic uraemic syndrome, Inappropriate schedule of drug administration, Intubation, Peritoneal dialysis
Clinical narrative: Received vaccines on 11/9/07. Became ill with diarrhea and decreased appetite on 11/10/07. Symptoms continued throughout weekend with appetite continually decreasing and urine output declining. Encouraged Pedialyte and feeds often, gave Tylenol (though my son was afebrile) under direction of various oncall nurses and MD. Took son to Pediatrician Monday-physical exam only-sent home. Took son to ER early Tuesday a.m. Requesting labs as still no appetite, continued diarrhea and occasional vomiting. Labs showed HUS with acute kidney failure. Hgb of 5, K+ 7.8, blood pressure 190-200's systolic. Life flighted to Hospital. Surgery for placement of peritoneal dialysis catheter placed, continuing peritoneal dialysis initiated, intubated and on ventilator for 8 days, multiple surgeries for line and port placements and removals, EGD for diagnosis of GI bleed, 4 weeks stay in PICU and 1 week in Pediatrics. Continues to be followed by pediatric nephrologist and cardiologist.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Renal failure acute, Surgery, Urine output decreased, Vomiting
Clinical narrative: Received vaccines on 11/9/07. Became ill with diarrhea and decreased appetite on 11/10/07. Symptoms continued throughout weekend with appetite continually decreasing and urine output declining. Encouraged Pedialyte and feeds often, gave Tylenol (though my son was afebrile) under direction of various oncall nurses and MD. Took son to Pediatrician Monday-physical exam only-sent home. Took son to ER early Tuesday a.m. Requesting labs as still no appetite, continued diarrhea and occasional vomiting. Labs showed HUS with acute kidney failure. Hgb of 5, K+ 7.8, blood pressure 190-200's systolic. Life flighted to Hospital. Surgery for placement of peritoneal dialysis catheter placed, continuing peritoneal dialysis initiated, intubated and on ventilator for 8 days, multiple surgeries for line and port placements and removals, EGD for diagnosis of GI bleed, 4 weeks stay in PICU and 1 week in Pediatrics. Continues to be followed by pediatric nephrologist and cardiologist.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a 12 week old female with diaper rash who on 01-NOV-2007 was vaccinated with a first oral dose of RotaTeq (lot# 656379/0505U). Concomitant vaccines included PEDIARIX, a dose of ACTHIB, and a dose of PREVNAR. Concomitant medication included topical nystatin. One week after receiving RotaTeq, on 08-NOV-2007, the patient experienced intussusception and was hospitalized. Subsequently, the patient recovered from intussusception. No product quality complaint was involved. No other information was provided. The reporter considered the patient's intussusception to be immediately life-threatening. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Ultrasound scan abnormal
Clinical narrative: Information has been received from a physician concerning a 12 week old female with diaper rash who on 01-NOV-2007 was vaccinated with a first oral dose of RotaTeq (lot# 656379/0505U). Concomitant vaccines included PEDIARIX, a dose of ACTHIB, and a dose of PREVNAR. Concomitant medication included topical nystatin. One week after receiving RotaTeq, on 08-NOV-2007, the patient experienced intussusception and was hospitalized. Subsequently, the patient recovered from intussusception. No product quality complaint was involved. No other information was provided. The reporter considered the patient's intussusception to be immediately life-threatening. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a physician concerning a 12 week old female with diaper rash who on 01-NOV-2007 was vaccinated with a first oral dose of RotaTeq (lot# 656379/0505U). Concomitant vaccines included PEDIARIX, a dose of ACTHIB, and a dose of PREVNAR. Concomitant medication included topical nystatin. One week after receiving RotaTeq, on 08-NOV-2007, the patient experienced intussusception and was hospitalized. Subsequently, the patient recovered from intussusception. No product quality complaint was involved. No other information was provided. The reporter considered the patient's intussusception to be immediately life-threatening. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: 1 day after receiving vaccine began developing facial rash - unknown if related to vaccine?  Patient was seen in clinic for first time 6 days after vaccination for this mild facial rash.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Dyspnoea, Hyperhidrosis, Injection site erythema
Clinical narrative: Joint pain, some SOB, nausea, chills, and sweats. 4 cm erythematous area at site of injection.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Joint pain, some SOB, nausea, chills, and sweats. 4 cm erythematous area at site of injection.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Oedema peripheral, Pain
Clinical narrative: Swollen deltoid muscle with extreme pain to point of immobility lasting almost 2 days. Some nausea.
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA, VARCEL
Symptoms: Discomfort, Injection site urticaria, Pain, Skin warm, Swelling
Clinical narrative: Patient was given the vaccine on Monday 1/21/087.  Upon waking on 1/22/08, we noticed welt over 2 inches in diameter at the site of the shot- his left thigh.  I called the Dr. office and was assured that a side effect can be redness and swelling.  There was little discomfort.  Upon waking on Wed 1/23, patient was in a lot of pain and there was another red mark surrounding the original welt.  The new mark was almost 5 inches in diameter.  I brought him to the Dr.s office immediately and he was seen by Dr.  I had given patient children's Motrin, but it did nothing to mask his pain.  The welt was HOT to the touch.  I was told to wait and see if it continued to get worse or if it hardened.   I called the Dr.'s office that afternoon to see if I could give patient an adult form of ibuprofen as he is 97lbs and was extremely uncomfortable.  The Dr.s office decided to prescribe codeine and to start an antibiotic as codeine can mask signs of infection.
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given the vaccine on Monday 1/21/087.  Upon waking on 1/22/08, we noticed welt over 2 inches in diameter at the site of the shot- his left thigh.  I called the Dr. office and was assured that a side effect can be redness and swelling.  There was little discomfort.  Upon waking on Wed 1/23, patient was in a lot of pain and there was another red mark surrounding the original welt.  The new mark was almost 5 inches in diameter.  I brought him to the Dr.s office immediately and he was seen by Dr.  I had given patient children's Motrin, but it did nothing to mask his pain.  The welt was HOT to the touch.  I was told to wait and see if it continued to get worse or if it hardened.   I called the Dr.'s office that afternoon to see if I could give patient an adult form of ibuprofen as he is 97lbs and was extremely uncomfortable.  The Dr.s office decided to prescribe codeine and to start an antibiotic as codeine can mask signs of infection.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site bruising, Injection site nodule
Clinical narrative: Hard nodule to injection site and bruise approx 4 cm in diameter.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Antiphospholipid antibodies, Antiphospholipid syndrome, Caesarean section, Cardiolipin antibody, Drug exposure during pregnancy
Clinical narrative: Information has been received from a 26 year old female consumer, who was vaccinated with the first dose, 0.5ml, IM, of Gardasil (Lot # not provided, date unspecified), and had unknowingly become pregnant, estimated date of conception, 22-MAY-2007 (on 19-JUN-2007, she was "4 weeks pregnant"). On 04-JUN-2007, she was vaccinated with the second dose, 0.5ml, of Gardasil (Lot # not provided). There was no concomitant medication, and no other pertinent medical history. On 19-JUN-2007, she reported a pregnancy test had confirmed her pregnancy. The estimated date of delivery was 28-FEB-2008. The consumer confirmed that she has had no ill effects. Follow up information received from a physician's office, indicated that this was the patient's first pregnancy, and added that she was a tobacco user. On 03-JUL-2007 through 08-JUL-2007, she was treated for gout, with prednisone, 5mg (no other details provided). On 10-JUL-2007, a pregnancy ultrasound was normal. The were no other illnesses or infections during pregnancy. On 10-DEC-2007, the patient underwent an ultrasound due to decreased fetal movement, and it was determined that the infant had severe intrauterine growth retardation (IUGR). It was also determined that the patient had placental insufficiency. Lab testing revealed the mother was positive for methylene-tetra-hydro-folate reductase (MTHFR) mutation homozygous and included cardiolipin ob and lupus anticoagulant testing (results not provided). The patient was diagnosed with antiphospholipid syndrome. An "emergent classical" caesarean section was performed, resulting in the live birth of a male infant, weight 700 gm, Apgar score 4/8. On 12-DEC-2007, the infant died, due to complications from prematurity. An autopsy on the infant was pending. The outcome of gout. MTHFR homozgous and antiphopholipid syndrome was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Foetal disorder, Foetal growth retardation, Gout, Intra-uterine death, Placental disorder
Clinical narrative: Information has been received from a 26 year old female consumer, who was vaccinated with the first dose, 0.5ml, IM, of Gardasil (Lot # not provided, date unspecified), and had unknowingly become pregnant, estimated date of conception, 22-MAY-2007 (on 19-JUN-2007, she was "4 weeks pregnant"). On 04-JUN-2007, she was vaccinated with the second dose, 0.5ml, of Gardasil (Lot # not provided). There was no concomitant medication, and no other pertinent medical history. On 19-JUN-2007, she reported a pregnancy test had confirmed her pregnancy. The estimated date of delivery was 28-FEB-2008. The consumer confirmed that she has had no ill effects. Follow up information received from a physician's office, indicated that this was the patient's first pregnancy, and added that she was a tobacco user. On 03-JUL-2007 through 08-JUL-2007, she was treated for gout, with prednisone, 5mg (no other details provided). On 10-JUL-2007, a pregnancy ultrasound was normal. The were no other illnesses or infections during pregnancy. On 10-DEC-2007, the patient underwent an ultrasound due to decreased fetal movement, and it was determined that the infant had severe intrauterine growth retardation (IUGR). It was also determined that the patient had placental insufficiency. Lab testing revealed the mother was positive for methylene-tetra-hydro-folate reductase (MTHFR) mutation homozygous and included cardiolipin ob and lupus anticoagulant testing (results not provided). The patient was diagnosed with antiphospholipid syndrome. An "emergent classical" caesarean section was performed, resulting in the live birth of a male infant, weight 700 gm, Apgar score 4/8. On 12-DEC-2007, the infant died, due to complications from prematurity. An autopsy on the infant was pending. The outcome of gout. MTHFR homozgous and antiphopholipid syndrome was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test positive, Ultrasound scan abnormal
Clinical narrative: Information has been received from a 26 year old female consumer, who was vaccinated with the first dose, 0.5ml, IM, of Gardasil (Lot # not provided, date unspecified), and had unknowingly become pregnant, estimated date of conception, 22-MAY-2007 (on 19-JUN-2007, she was "4 weeks pregnant"). On 04-JUN-2007, she was vaccinated with the second dose, 0.5ml, of Gardasil (Lot # not provided). There was no concomitant medication, and no other pertinent medical history. On 19-JUN-2007, she reported a pregnancy test had confirmed her pregnancy. The estimated date of delivery was 28-FEB-2008. The consumer confirmed that she has had no ill effects. Follow up information received from a physician's office, indicated that this was the patient's first pregnancy, and added that she was a tobacco user. On 03-JUL-2007 through 08-JUL-2007, she was treated for gout, with prednisone, 5mg (no other details provided). On 10-JUL-2007, a pregnancy ultrasound was normal. The were no other illnesses or infections during pregnancy. On 10-DEC-2007, the patient underwent an ultrasound due to decreased fetal movement, and it was determined that the infant had severe intrauterine growth retardation (IUGR). It was also determined that the patient had placental insufficiency. Lab testing revealed the mother was positive for methylene-tetra-hydro-folate reductase (MTHFR) mutation homozygous and included cardiolipin ob and lupus anticoagulant testing (results not provided). The patient was diagnosed with antiphospholipid syndrome. An "emergent classical" caesarean section was performed, resulting in the live birth of a male infant, weight 700 gm, Apgar score 4/8. On 12-DEC-2007, the infant died, due to complications from prematurity. An autopsy on the infant was pending. The outcome of gout. MTHFR homozgous and antiphopholipid syndrome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dyskinesia, Loss of consciousness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old female who on 02-NOV-2007 was vaccinated with her first dose of Gardasil (Lot #658554/0928U) via injection and on 28-DEC-2007 was vaccinated with her second dose of Gardasil (Lot #658554/0928U). There was no concomitant medication. The nurse said that the patient was not pregnant during the two visits but the medical assistant said that the patient jerked and "went out immediately" after each dose and she seemed to be having a seizure. The patient recovered both times while she was in the office. They will not be administering dose 3. The patient did not receive any other vaccinations during her visits. She has no pertinent medical history and no lab/diagnostic studies were performed. No other details were available. A seizure was considered to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: Information has been received through the Merck pregnancy registry from a health professional concerning a female who on 07-DEC-2007 was vaccinated intramuscularly with the first dose of Gardasil. Per the reporter, the patient was 3 weeks pregnant at the time of vaccination and subsequently experienced vaccine exposure during pregnancy. On approximately 05-JAN-2008 the patient experienced elective termination of pregnancy (gestation = 7 weeks). No other information was available. Elective termination of pregnancy was considered to be an other important medical event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 13 year old female who in 2007 was vaccinated intramuscularly with the third dose of Gardasil. Per the reporter, the patient started experiencing seizures 3 months after the final dose of Gardasil. No further information was provided. Experiencing seizures is considered to be an other important medical event. Additional information has been requested.