chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HIBV
Symptoms: Autism
Clinical narrative: This case was considered medically important. Information regarding Hib-Titer Vaccine was received from a father of a male patient who received the fifth dose on either 17-Dec-2002 or 15-Jan-2003 and experienced autism. On 17-Dec-2002 or 15-Jan-2003, the patient received the fifth dose of Hib-Titer. In early 2003, the child was diagnosed with autism. The patient had not recovered from the event. No additional information was available at the time of this report.
Sex: M
Vaccine: HIBV
Symptoms: Autism
Clinical narrative: This case was considered medically important. Information regarding Hib-Titer was received from a father of a male patient who received the fifth dose on either 17-Dec-2002 or 15-Jan-2003 and experienced autism. On either 17-Dec-2002 or 15-Jan-2003, the patient received the fifth dose of Hib-Titer. In early 2003, the child was diagnosed with autism. The patient had not recovered from the event. No additional information was available at the time of this report.
Age: 1.9
Sex: M
Vaccine: MMRV
Symptoms: Rash papular, Rash vesicular, Varicella
Clinical narrative: Vesicular and papular rash diffuse on body - chicken pox
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Pyrexia, Rash, Varicella
Clinical narrative: Outbreak of Varicella illness-rash, low grade fever.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: woke around 7:00 a.m. with low grade fever, then around 1:00 p.m. fever up to 104 deg. The site around the injection site were red and hard mom treated sx with tylenol. Fever came down. Redness and hardness went away after almost a week.
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: persistent swelling, tenderness, mild warmth left deltoid area after 9/23/07 not seen in office 5/30 prescribed PRN Tylenol, observation
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Body temperature increased, Haematemesis, Occult blood positive
Clinical narrative: Pt developed bloody emesis the evening after she was given her 2nd Rotateq vaccine. Mom also reported, low grade temp (99-100f) but no real fever. Pt was not excessively fussy-Mom advised to come in next day to have stools hemoculture and stools tested positive for blood 6/1/07-PCP called:No hospital.  Looks very good clinically but still tests + for blood in stool when seen in office yesterday.  RV test & stool c/s have been sent.  Has no s/s of milk protein allergy.  Heme + emesis only 1 x. krk 06/05/07-note received from PCP for DOS 5/30/07-parent reports one episode of emesis reports blood in emesis. Patient had dose of red Triaminic for congestion. No diarrhea, mild fever 99-100. No further vomiting.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Fall, Nausea
Clinical narrative: Approx 5 min after vacc adm. Pt was stopped at check out, seizure type movement noted as pt fell to floor. Fall somewhat blocked by another pt standing near. Pt with nausea, no vomiting. Pt alert/talking few min after episode. BP 84/52 P-48 Pt to Urgent Care Ctr in Stable condition.
Age: 17.0
Sex: M
Vaccine: HEP, MNQ, TDAP
Symptoms: Dyskinesia, Immediate post-injection reaction, Loss of consciousness, Pallor
Clinical narrative: 17 Year old male to super shot for Tdap, Hep B and Menactra vaccine, Tdap and Hep B vaccine given in right deltoid (2 separate) injections. Immediate after giving 3rd injection, Menactra in left deltoid patient became pale at passed out. Writer called for help from another nurse. We assisted client from the chair to the floor. Patient made a few brief jerking gestures. After calling his name out he was  aware of his person, place at time , with a smile on his face. The whole situation lasted approximately 5-7 seconds. Client was kept in the clinic for observation for 10-15 minutes. 24 hour re-call to family found patient to be without ill effects.
Sex: F
Vaccine: FLU3, HEP
Symptoms: Wrong drug administered
Clinical narrative: Hepatitis B vaccine to be administered to newborn. Stored in same refrigerator, or nursing unit, as Fluarix. Products are in very similar box and syringes look almost identical. Fluarix was administered to newborn by mistake instead of Engerix-B.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient seen on 5/24/07 for left leg pain and redness at injection site x 3 days. Symptoms improving. No treatment. Monitor for worsening symptoms.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Reports she developed 1st outbreak of genital warts, treated after vaccine #1 (few external lesions, treated by her GYN). A more severe outbreak (extended intravaginally) occurred 1-2 weeks after #2. No or mild outbreak occurred after #3.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Decreased activity, Decreased appetite, Feeling hot, Gait disturbance, Injection site bruising
Clinical narrative: Vaccines received 5/30/07 mom noted decreased in patient activity approximately 1700 on 5/30/07. Patient felt hot and wobbly. States stepping on "tippy toes" with "light shakes" on 5/30/07 and 5/31/07 (AM).  Decrease activity, decrease appetite. Right deltoid seem bruise. Right deltoid erythema ring around injection site.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Tremor
Clinical narrative: Vaccines received 5/30/07 mom noted decreased in patient activity approximately 1700 on 5/30/07. Patient felt hot and wobbly. States stepping on "tippy toes" with "light shakes" on 5/30/07 and 5/31/07 (AM).  Decrease activity, decrease appetite. Right deltoid seem bruise. Right deltoid erythema ring around injection site.
Age: 10.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Breakout
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Rash generalised
Clinical narrative: Break out all over body.
Age: 28.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Dizziness, Injection site rash, Injection site urticaria, Palpitations
Clinical narrative: Hives and rash at injection site (right deltoid) dizziness  and palpitations noted by patient 2-3 minutes after injection. Tx: 50 mg IM administered of Benadryl.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Induration
Clinical narrative: Left arm induration ice applied.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Left thigh swollen/ itchy.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient seen on 5/21/07 for redness and swelling at injection site. Symptoms improved, no treatment needed.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Had 1st Hep B vaccine on Wednesday (5/16) at 1:00pm. Noticed hives on forehead, cheeks, behind ears and back of neck at 11:0am (5/17). Took Benadryl and Chlorpheneramine but did not notice improvement. Hives left Monday night roughly (5/21). Had little on Tuesday (5/22).
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Vision blurred
Clinical narrative: 2nd Dose received Hep B vaccine 40mg IM 5-21-07 and patient contacted me (nurse) 5-23-07 and stated evening of 5-21 she got a film over her right eye. Went to eye doctor 5-22-07 and he stated it was her cornea and is sending her to cornea transplant doctor 6-5-07.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Nausea, Pyrexia, Tachycardia, Vomiting
Clinical narrative: Approximately 2 hours after vaccine was given, patient complain of  nausea and tachycardia. During the night she had nausea/ vomiting, slight fever and tachycardia. She saw her ped physician on 5-9-07. Patient spent time at ER on 5-10 and 5-11 with the same symptoms. She has since seen doctor who had referred patient to a pediatric cardiologist will see her 6-6-07.
Age: 30.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Mass
Clinical narrative: Hard lump approximately 8mm right upper arm
Sex: F
Vaccine: ANTH
Symptoms: Contusion, Injection site mass
Clinical narrative: Lump around injection site, patient states she is bruised. Denies any pain, declines to see a provider at this time.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody negative, Confusional state, Full blood count normal, Headache, Laboratory test
Clinical narrative: Patient experienced bouts of confusion and blurry vision, headache described as starting over L eye and a "weird feeling" spreads accross the forehead.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Nervous system disorder, Nuclear magnetic resonance imaging abnormal, Vision blurred
Clinical narrative: Patient experienced bouts of confusion and blurry vision, headache described as starting over L eye and a "weird feeling" spreads accross the forehead.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Balance disorder, Confusional state, Disturbance in attention, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: Confusion with a slight headache described as "weird feeling",  unable to concentrate  for 3 days,  vision problems- blurry, unfocused- patient said was "very scary, i kept telling myself where i was so i wouldn't forget because this happened with my last dose of the vaccine" loss of balance
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Similar reaction on previous exposure to drug, Vision blurred
Clinical narrative: Confusion with a slight headache described as "weird feeling",  unable to concentrate  for 3 days,  vision problems- blurry, unfocused- patient said was "very scary, i kept telling myself where i was so i wouldn't forget because this happened with my last dose of the vaccine" loss of balance
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: syncope after adm of vaccine
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Body aches, starting the night Tdap was given.  Took Advil for 2 days. Better on 3rd.day.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient called to let us know she had a large, red, swollen aread at injection site for 3 days.  Also had itching at site.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Body temperature increased, Chest X-ray, Dizziness, Headache, Nausea
Clinical narrative: Nausea, fever, headache, dizzy-5/19/07
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Pyrexia
Clinical narrative: Nausea, fever, headache, dizzy-5/19/07
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Oedema peripheral
Clinical narrative: The administration of DTaP was completed on this child on 12/15/2007 at the Health Clinic.  This Public Health Nurse received a call  Monday, 12/18/2006, from patient's mother stating that the vaccine was given on 12/15/2006, and the child woke up that next morning with swelling of his left arm from the elbow to his shoulder.  Mom took child to his doctor at Clinic on 12/16, and he was given Benadryl and the symptoms gradually subsided.
Age: 61.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Developed erythema, induration, and pruritis around vaccination area (Tdap) on left upper anterior arm, 72 hours after vaccination.  No treatment, symptoms have begun to resolve now (one week later) though some redness, induration, and pruritis remain.  No other effect on left upper extremity.
Age: 29.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Injection site discolouration, Injection site mass, Reaction to preservatives
Clinical narrative: ANTHRAX BOOSTER (SHOT #9 IN THE SERIES) ON 23 MAY 2007. ON THE AFTERNOON OF 24 MAY, PT COMPLAINED OF A LARGE DARK PURPLE AREA, AND BIG LUMP AT THE INJECTION SITE. ON 31 MAY 07, PT WAS SEEN BY PCM FOR EVALUATION. PT STATES THAT PCM READ THE ANTHRAX VIS AND CONCLUDED THAT THIS WAS A MODERATE REACTION AND COMPLETE A VAERS FORM. PT WAS PRESCRIBED TYLENOL.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Pain, Paraesthesia, Pruritus
Clinical narrative: At first she experienced itching, tingling, burning, and a mild "painful feeling" but only on one side of her body and face.  A few days later a rash appeared in the same places on her skin and blisters formed that filled with pus.  The pain increased significantly ranging from moderate tenderness, burning to severe throbbing pain that was stabbing and shooting. She is still suffering from these symptoms. 06/05/07-records received for DOS 05/30/07-Monitored overnight. Impression: Syncope secondary to combination of hypokalemia, possible arrhythmia, hypovolemia and fatigue. Returned from visit  did not sleep well past several nights. Developed shingles. Prior to ER visit fell to side and passed out. did not lose bladder control.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Tenderness
Clinical narrative: At first she experienced itching, tingling, burning, and a mild "painful feeling" but only on one side of her body and face.  A few days later a rash appeared in the same places on her skin and blisters formed that filled with pus.  The pain increased significantly ranging from moderate tenderness, burning to severe throbbing pain that was stabbing and shooting. She is still suffering from these symptoms. 06/05/07-records received for DOS 05/30/07-Monitored overnight. Impression: Syncope secondary to combination of hypokalemia, possible arrhythmia, hypovolemia and fatigue. Returned from visit  did not sleep well past several nights. Developed shingles. Prior to ER visit fell to side and passed out. did not lose bladder control.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: At first she experienced itching, tingling, burning, and a mild "painful feeling" but only on one side of her body and face.  A few days later a rash appeared in the same places on her skin and blisters formed that filled with pus.  The pain increased significantly ranging from moderate tenderness, burning to severe throbbing pain that was stabbing and shooting. She is still suffering from these symptoms. 06/05/07-records received for DOS 05/30/07-Monitored overnight. Impression: Syncope secondary to combination of hypokalemia, possible arrhythmia, hypovolemia and fatigue. Returned from visit  did not sleep well past several nights. Developed shingles. Prior to ER visit fell to side and passed out. did not lose bladder control.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Lip blister, Tongue discolouration
Clinical narrative: Child received immunizations on Tuesday, 5/29/07 around 1:30pm.  Around 7:00pm that evening, mother noticed white spots on tip of tongue and blisters on his lip.  The next morning, it was spread over his whole tongue and had more blisters on his lip.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Reaction to preservatives
Clinical narrative: REATION ON L ARM TO SC VZV, MEASURED 50MM X 50MM
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Decreased appetite, Fatigue, Headache, Irritability, Lymph node pain
Clinical narrative: Symptoms:  Still experiencing swollen and tender lymph nodes on/around neck/collar bone area after two months, either side or both at a time.  Mild fever, sore throat, loss of appetite, fatigue, irritability, and headaches.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphadenopathy, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Symptoms:  Still experiencing swollen and tender lymph nodes on/around neck/collar bone area after two months, either side or both at a time.  Mild fever, sore throat, loss of appetite, fatigue, irritability, and headaches.
Age: 53.0
Sex: F
Vaccine: HEPAB, IPV
Symptoms: Abdominal pain, Headache, Pyrexia, Vomiting
Clinical narrative: Patient states that at 03:00 on 5/31/07, she had Headache, fever of 100 f, abdominal pain, and vomiting.  Called her at 11:00 on 5/31/07 and she reported that she felt a little better.  She was concerned that the symptoms were related to the vaccines she received on 5/30/07.  Advised her to call back if no improvement, or see MD, and she or husband have not called back as of this moment.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site pruritus, Pain, Pruritus
Clinical narrative: Significant red, raised, and indurated area, approximately 1" x 1.75", pruritic, oval-shaped traveling downward arm with beginning upstream site of injection. Noticed upon child's complaint shortly after she arose. Recovery not established as of 5/31/07 at 6:15pm since significant itching, redness, and discomfort still exists, but it is likely. Treatment with cool packs at home.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Immediate post-injection reaction, Injection site pain, Similar reaction on previous exposure to drug
Clinical narrative: Significant pain at injection site immediately upon (and during) both first and second injections (12/14/2006 lot 0688f and 2/16/2007 lot 1447F). Pain decreased rapidly within a minute but ache remained for approximately an hour. Daughter described pain as "worst pain after any injection she's ever had".
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Blood creatinine, Blood electrolytes, Blood glucose, Blood urea, Brachial plexopathy
Clinical narrative: ARM PROBLEM - x1 week, experiencing sharp constant pain to L arm radiating to L arm, shoulder, back. Pt. states pain started after receiving Tdap last week. Who complains of left shoulder pain after tetanus immunization; very distraught. Notes full ROM; pain is described as burning in nature; spread from deltoid original to now post chest wall - stabbing quality; not pleuritic and not exertional; no shortness of breath.                                          Rxn to immunization vs brachial plexus or cervical impingment? Will try nsaids, local measures Ck films given disporportionate pain to exam Close follow up for failure to improve. *** pt history of Td > 5 years ago.                                                                                                 4 days later pain persist, given course of steroids
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, C-reactive protein, Chest X-ray, Full blood count, Immunisation reaction
Clinical narrative: ARM PROBLEM - x1 week, experiencing sharp constant pain to L arm radiating to L arm, shoulder, back. Pt. states pain started after receiving Tdap last week. Who complains of left shoulder pain after tetanus immunization; very distraught. Notes full ROM; pain is described as burning in nature; spread from deltoid original to now post chest wall - stabbing quality; not pleuritic and not exertional; no shortness of breath.                                          Rxn to immunization vs brachial plexus or cervical impingment? Will try nsaids, local measures Ck films given disporportionate pain to exam Close follow up for failure to improve. *** pt history of Td > 5 years ago.                                                                                                 4 days later pain persist, given course of steroids
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Musculoskeletal chest pain, Musculoskeletal pain, Pain in extremity, Spinal X-ray
Clinical narrative: ARM PROBLEM - x1 week, experiencing sharp constant pain to L arm radiating to L arm, shoulder, back. Pt. states pain started after receiving Tdap last week. Who complains of left shoulder pain after tetanus immunization; very distraught. Notes full ROM; pain is described as burning in nature; spread from deltoid original to now post chest wall - stabbing quality; not pleuritic and not exertional; no shortness of breath.                                          Rxn to immunization vs brachial plexus or cervical impingment? Will try nsaids, local measures Ck films given disporportionate pain to exam Close follow up for failure to improve. *** pt history of Td > 5 years ago.                                                                                                 4 days later pain persist, given course of steroids
Age: 27.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Fatigue, Headache, Influenza like illness, Mobility decreased, Myalgia
Clinical narrative: Reaction to pneumovax: rash, nausea, low grade fever
Age: 27.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Reaction to pneumovax: rash, nausea, low grade fever
Age: 27.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nausea, Pyrexia, Rash
Clinical narrative: Reaction to pneumovax: rash, nausea, low grade fever
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV, DTPIPV, MMRV
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This report was received from manufacturer and was assigned manufacturer report number (A0650497A) for INFANRIX. A 4 year old male with a history of extrinsic asthma, respiratory tract infections, and a unspecified reaction to oxybenzoyl described as a rash from baby oil, on 03-MAY-2007, was vaccinated with a second dose in the left arm of Proquad (lot # 656307/1391F). Suspect vaccination on the same day included a 0.5 mL fifth dose in the left arm of INFANRIX (lot # AC14B056BA). Other concomitant therapy included albuterol sulfate and budesonide (PULMICORT) nebulized. On 04-MAY-2007, within 24 hours of receiving the vaccinations, the patient's left arm became swollen and red, and he developed a fever of 104 degrees Fahrenheit. The patient was treated with ibuprofen (MORTIN) and diphenhydramine hydrochloride (BENADRYL) with no improvement in symptoms. On 05-MAY-2007 at 15:43 PM, the patient presented at the physician's office and was diagnosed with cellulitis. The patient's left arm was swollen from the deltoid to th elbow, his skin was taut, warm to the touch, and red. The patient was prescribed amoxicillin trihydrate (+) potassium clavulanate (AUGMENTIN) for 10 days. At the time of reporting, the arm cellulitis, swelling, redness, and warmness to the touch were improved, but the outcome of the fever and skin tautness was not specified. The reporter considered the events were possibly related to vaccination with MMRV and INFANRIX. Per the source document, the reporter was uncertain if cellulitis was due to Proquad or INFANRIX since both vaccines were received on the same day. The patient had no history of adverse events following previous vaccinations. The patient's experience were considered to be other important medical events. This was originally reported by a registered nurse. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV, DTPIPV, MMRV
Symptoms: Pyrexia, Skin tightness
Clinical narrative: This report was received from manufacturer and was assigned manufacturer report number (A0650497A) for INFANRIX. A 4 year old male with a history of extrinsic asthma, respiratory tract infections, and a unspecified reaction to oxybenzoyl described as a rash from baby oil, on 03-MAY-2007, was vaccinated with a second dose in the left arm of Proquad (lot # 656307/1391F). Suspect vaccination on the same day included a 0.5 mL fifth dose in the left arm of INFANRIX (lot # AC14B056BA). Other concomitant therapy included albuterol sulfate and budesonide (PULMICORT) nebulized. On 04-MAY-2007, within 24 hours of receiving the vaccinations, the patient's left arm became swollen and red, and he developed a fever of 104 degrees Fahrenheit. The patient was treated with ibuprofen (MORTIN) and diphenhydramine hydrochloride (BENADRYL) with no improvement in symptoms. On 05-MAY-2007 at 15:43 PM, the patient presented at the physician's office and was diagnosed with cellulitis. The patient's left arm was swollen from the deltoid to th elbow, his skin was taut, warm to the touch, and red. The patient was prescribed amoxicillin trihydrate (+) potassium clavulanate (AUGMENTIN) for 10 days. At the time of reporting, the arm cellulitis, swelling, redness, and warmness to the touch were improved, but the outcome of the fever and skin tautness was not specified. The reporter considered the events were possibly related to vaccination with MMRV and INFANRIX. Per the source document, the reporter was uncertain if cellulitis was due to Proquad or INFANRIX since both vaccines were received on the same day. The patient had no history of adverse events following previous vaccinations. The patient's experience were considered to be other important medical events. This was originally reported by a registered nurse. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV, DTPIPV, MMRV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pyrexia
Clinical narrative: This report was received from manufacturer and was assigned manufacturer report number (A0650497A) for INFANRIX. A 4 year old male with a history of extrinsic asthma, respiratory tract infections, and a unspecified reaction to oxybenzoyl described as a rash from baby oil, on 03-MAY-2007, was vaccinated with a second dose in the left arm of Proquad (lot # 656307/1391F). Suspect vaccination on the same day included a 0.5 mL fifth dose in the left arm of INFANRIX (lot # AC14B056BA). Other concomitant therapy included albuterol sulfate and budesonide (PULMICORT) nebulized. On 04-MAY-2007, within 24 hours of receiving the vaccinations, the patient's left arm became swollen and red, and he developed a fever of 104 degrees Fahrenheit. The patient was treated with ibuprofen (MORTIN) and diphenhydramine hydrochloride (BENADRYL) with no improvement in symptoms. On 05-MAY-2007 at 15:43 PM, the patient presented at the physician's office and was diagnosed with cellulitis. The patient's left arm was swollen from the deltoid to th elbow, his skin was taut, warm to the touch, and red. The patient was prescribed amoxicillin trihydrate (+) potassium clavulanate (AUGMENTIN) for 10 days. At the time of reporting, the arm cellulitis, swelling, redness, and warmness to the touch were improved, but the outcome of the fever and skin tautness was not specified. The reporter considered the events were possibly related to vaccination with MMRV and INFANRIX. Per the source document, the reporter was uncertain if cellulitis was due to Proquad or INFANRIX since both vaccines were received on the same day. The patient had no history of adverse events following previous vaccinations. The patient's experience were considered to be other important medical events. This was originally reported by a registered nurse. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter with a history of seizures who on 06-NOV-2006 was vaccinated with a 1st dose of Gardasil. Concomitant therapy included oxcarbazepine (TRILEPTAL). Two weeks after getting the first dose of Gardasil she developed a seizure. She sought medical attention, and no lab diagnostic studies were performed. Subsequently she recovered. As of 24-MAY-2007 she had yet to get the second and third dose of Gardasil. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Allergy test, Blood immunoglobulin E, Blood test, Cough, Dyspnoea
Clinical narrative: Information has been received from a physician concerning a 4 year old male with egg allergy and milk allergy who in approximately 2004 was vaccinated with MMR II without any problems. On 14-MAY-2007 the patient was vaccinated with a dose of MMR II. The patient experienced could not breathe, coughing, throat was closing, hypoxic, hives, itchy, oxygen saturation was in the 80's and "the child was throwing his clothes off." Child was given an epinephrine injection, oxygen and was monitored at the office and was released. Child was not hospitalized. Child did not have this type of reaction when he received his first dose, which was a couple of years ago. It was reported that all types of lab blood work was performed, including. IgE, and allergy testing for gelatin and bovine serum. Subsequently, the patient recovered. The events were considered to be to immediately life-threatening and considered serious due to be an Other Important Medical Event. No product quality complaint. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Haematology test, Hypoxia, Oxygen saturation decreased, Pruritus, Throat tightness
Clinical narrative: Information has been received from a physician concerning a 4 year old male with egg allergy and milk allergy who in approximately 2004 was vaccinated with MMR II without any problems. On 14-MAY-2007 the patient was vaccinated with a dose of MMR II. The patient experienced could not breathe, coughing, throat was closing, hypoxic, hives, itchy, oxygen saturation was in the 80's and "the child was throwing his clothes off." Child was given an epinephrine injection, oxygen and was monitored at the office and was released. Child was not hospitalized. Child did not have this type of reaction when he received his first dose, which was a couple of years ago. It was reported that all types of lab blood work was performed, including. IgE, and allergy testing for gelatin and bovine serum. Subsequently, the patient recovered. The events were considered to be to immediately life-threatening and considered serious due to be an Other Important Medical Event. No product quality complaint. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 4 year old male with egg allergy and milk allergy who in approximately 2004 was vaccinated with MMR II without any problems. On 14-MAY-2007 the patient was vaccinated with a dose of MMR II. The patient experienced could not breathe, coughing, throat was closing, hypoxic, hives, itchy, oxygen saturation was in the 80's and "the child was throwing his clothes off." Child was given an epinephrine injection, oxygen and was monitored at the office and was released. Child was not hospitalized. Child did not have this type of reaction when he received his first dose, which was a couple of years ago. It was reported that all types of lab blood work was performed, including. IgE, and allergy testing for gelatin and bovine serum. Subsequently, the patient recovered. The events were considered to be to immediately life-threatening and considered serious due to be an Other Important Medical Event. No product quality complaint. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction, Cardiac arrest, Death
Clinical narrative: Information has been received from a nurse practitioner who heard from an emergency room (ER) nurse that an 11 year old female was vaccinated "within in the past month" in approximately May 2007 with a first dose of Gardasil. Subsequently, 3 days after vaccination the patient presented to an ER. She experienced cardiac arrest, required lung bypass (ECMO) and "may not have expired." It was also reported by the same nurse that the physician from the hospital said that "the death was due to an anaphylactic reaction to Gardasil." The anaphylactic reaction and cardiac arrest were considered to be life threatening by the reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Musculoskeletal stiffness, No reaction on previous exposure to drug, Oedema peripheral, Pain
Clinical narrative: On 11/Oct/2006, a report was received, via a company representative concerning a 69-year-old female vaccinee. No details were provided regarding the vaccinee's medical history or concomitant medications. On 08/Oct/2006 the vaccinee received 0.5ml Fluvirin (batch number G9427), intramuscularly. On the same day, 08/Oct/2006, the vaccinee experienced a swollen arm, which was described as a cellulitis type swelling, from her shoulder to elbow. The vaccinee refused to take Benadryl. The symptoms continue. The vaccinee takes the flu shot every year and has not had this reaction before. Follow-up information will be sought. Follow up information was received on 21/May/2007 from a healthcare professional. No details were provided regarding the vaccinee's medical history or concomitant medications. The vaccinee received Fluvirin on 08/OCT/2006, one day later (09/Oct/2006) the vaccinee developed abnormal  swelling from the wrist to the shoulder. The event was treated with Benadryl and resolved in approximately 1 week. The reporter considered the event to be serious, medically significant as it caused pain and stiffness to the affected arm. No further information is expected.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: On 11/Oct/2006, a report was received, via a company representative concerning a 69-year-old female vaccinee. No details were provided regarding the vaccinee's medical history or concomitant medications. On 08/Oct/2006 the vaccinee received 0.5ml Fluvirin (batch number G9427), intramuscularly. On the same day, 08/Oct/2006, the vaccinee experienced a swollen arm, which was described as a cellulitis type swelling, from her shoulder to elbow. The vaccinee refused to take Benadryl. The symptoms continue. The vaccinee takes the flu shot every year and has not had this reaction before. Follow-up information will be sought. Follow up information was received on 21/May/2007 from a healthcare professional. No details were provided regarding the vaccinee's medical history or concomitant medications. The vaccinee received Fluvirin on 08/OCT/2006, one day later (09/Oct/2006) the vaccinee developed abnormal  swelling from the wrist to the shoulder. The event was treated with Benadryl and resolved in approximately 1 week. The reporter considered the event to be serious, medically significant as it caused pain and stiffness to the affected arm. No further information is expected.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Musculoskeletal stiffness, No reaction on previous exposure to drug, Oedema peripheral, Pain
Clinical narrative: On 11/Oct/2006, a report was received, via a company representative, concerning an 81-year-old female vaccinee (initials VB, DOB 10/05/1925). No details were provided regarding the vaccinee's medical history or concomitant medications. On 08/Oct/2006 the vaccinee received 0.5ml Fluvirin (batch number 69427), intramuscularly. On the same day, 08/Oct/2006, the vaccinee experienced a swollen arm, which was described as a cellulitis type swelling, from her shoulder to elbow. The swelling improved with Benadryl, but there is still some swelling. The vaccinee takes the flu shot every year and has not had this reaction before. Follow-up information will be sought. Follow up information was received on 21/May/2007 from a healthcare professional. No details were provided regarding the vaccinee's medical history or concomitant medications. The vaccinee received Fluvirin on 08/Oct/2006, one day later (09/Oct/2006) the vaccinee developed abnormal swelling from the wrist to the shoulder. The event was treated with Benadryl and resolved in approximately 1 week. The reporter considered the event to be serious, medically significant as it caused pain and stiffness to the affected arm. No further information is expected.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Anaphylactic reaction, Angioedema, Arthralgia, Back pain
Clinical narrative: A report was received from a healthcare professional on 12/Oct/2006 concerning a 44 year old female vaccinee. The vaccinee has a history of "allergies" and sees and allergist. Allergy testing was negative for egg allergy. No details of concomitant medication were provided. On 10/Oct/2006 the vaccinee received Fluvirin by intramuscular injection. By the evening she had developed facial swelling and her eyes were swollen shut. She was treated the next day with a steroid injection and antihistamines, and the facial swelling resolved overnight. On 12/Oct/2006 the vaccinee reported bilateral low back pain radiating to her thighs, pain upon rising from a seated position and severe pain in the left wrist. The vaccinee is being treated with oral prednisone. Further information has been requested. Follow-up report was received on 22/May/2007 regarding this 44-year-old female vaccinee. The vaccinee has a history of anxiety for years for which she has been treated intermittently and which was discontinued on 04/Oct/2006 (concomitant drug unknown, illegible). The vaccinee received Fluvirin 0.5mls intramuscularly on 10/Oct/2006. The same day she developed facial and periorbital oedema, and a generalised pruritic rash which was consistent with urticaria, which resolved on 20/Oct/2006. On 12/Oct/2006 the vaccine awoke and was unable to walk. This had resolved on 18/Oct/2006 after treatment with prednisone. The reporter considered the events to be serious and medically significant (possible angioedema/anaphylaxis).  The events periorbital oedema and generalised pruritus were considered to be possibly related to Fluvirin. The causality of the inability to walk was provided as unknown. No further information is expected.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Gait disturbance, Periorbital oedema, Rash pruritic, Swelling face
Clinical narrative: A report was received from a healthcare professional on 12/Oct/2006 concerning a 44 year old female vaccinee. The vaccinee has a history of "allergies" and sees and allergist. Allergy testing was negative for egg allergy. No details of concomitant medication were provided. On 10/Oct/2006 the vaccinee received Fluvirin by intramuscular injection. By the evening she had developed facial swelling and her eyes were swollen shut. She was treated the next day with a steroid injection and antihistamines, and the facial swelling resolved overnight. On 12/Oct/2006 the vaccinee reported bilateral low back pain radiating to her thighs, pain upon rising from a seated position and severe pain in the left wrist. The vaccinee is being treated with oral prednisone. Further information has been requested. Follow-up report was received on 22/May/2007 regarding this 44-year-old female vaccinee. The vaccinee has a history of anxiety for years for which she has been treated intermittently and which was discontinued on 04/Oct/2006 (concomitant drug unknown, illegible). The vaccinee received Fluvirin 0.5mls intramuscularly on 10/Oct/2006. The same day she developed facial and periorbital oedema, and a generalised pruritic rash which was consistent with urticaria, which resolved on 20/Oct/2006. On 12/Oct/2006 the vaccine awoke and was unable to walk. This had resolved on 18/Oct/2006 after treatment with prednisone. The reporter considered the events to be serious and medically significant (possible angioedema/anaphylaxis).  The events periorbital oedema and generalised pruritus were considered to be possibly related to Fluvirin. The causality of the inability to walk was provided as unknown. No further information is expected.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: A report was received from a healthcare professional on 12/Oct/2006 concerning a 44 year old female vaccinee. The vaccinee has a history of "allergies" and sees and allergist. Allergy testing was negative for egg allergy. No details of concomitant medication were provided. On 10/Oct/2006 the vaccinee received Fluvirin by intramuscular injection. By the evening she had developed facial swelling and her eyes were swollen shut. She was treated the next day with a steroid injection and antihistamines, and the facial swelling resolved overnight. On 12/Oct/2006 the vaccinee reported bilateral low back pain radiating to her thighs, pain upon rising from a seated position and severe pain in the left wrist. The vaccinee is being treated with oral prednisone. Further information has been requested. Follow-up report was received on 22/May/2007 regarding this 44-year-old female vaccinee. The vaccinee has a history of anxiety for years for which she has been treated intermittently and which was discontinued on 04/Oct/2006 (concomitant drug unknown, illegible). The vaccinee received Fluvirin 0.5mls intramuscularly on 10/Oct/2006. The same day she developed facial and periorbital oedema, and a generalised pruritic rash which was consistent with urticaria, which resolved on 20/Oct/2006. On 12/Oct/2006 the vaccine awoke and was unable to walk. This had resolved on 18/Oct/2006 after treatment with prednisone. The reporter considered the events to be serious and medically significant (possible angioedema/anaphylaxis).  The events periorbital oedema and generalised pruritus were considered to be possibly related to Fluvirin. The causality of the inability to walk was provided as unknown. No further information is expected.
Age: 21.0
Sex: F
Vaccine: FLUX, IPV, MNQ, TD, TYP, YF, FLU3, IPV, MNQ, TD, TYP, YF
Symptoms: Dermatomyositis, Electromyogram, Musculoskeletal discomfort
Clinical narrative: Pt developed dermatomyositis over the few months following her mass vaccines for international travel (see attached history). Dermatomyositis is a rare, very serious autoimmune inflammatory muscle/skin disease. 1/5/10 Ongoing serious autoimmune conditions-deramatologists is still requiring subatartial daily immunoserppriadats (Celliept and Prednisone) as well as IVIg infurine mortally.  06/04/2007 VAERS report submitted with unsigned HPI attached.  Pt. initially experience low grade temps and fatigue for several days following multiple vax for foriegn travel in May 2005.  Upon returning from travel in 8/2005 pt. again experienced low grade temps and fatigue as well as bilateral shoulder and upper arm muscle aches and soreness as well as weakness. Skin flushing and pruritic nodules noted on wrists and elbows. By 9/2005 muscle symptoms and fatigue had increased as well as cuticle changes.  Txd with steroids, IVIG, Minocycline and topical creams to skin. DX: Dermatomyositis.  07/03/2007 MR received from neurologist for several visits beginning 8/28/2005 to 12/08/2005 for initial c/o profound weakness in the arms which was progressing. Pt also c/o hip pain and tightness as well as some skin irritation around the nail cuticle and skin discoloration of the chest area and knees. PE significant for minimal neck flexion weakness as well as minimal biceps/triceps weakness. Knee reflexes depressed. Skin discoloration noted at the cuticles, eyelids, knees.  DX: Dermatomyositis. Pt admitted to hospital 10/23/2005 for increasing weakness, swallowing difficulty and head/neck weakness r/t the dermatomyositis.  F/U 12/8/2005 doing well.
Age: 21.0
Sex: F
Vaccine: FLUX, IPV, MNQ, TD, TYP, YF, FLU3, IPV, MNQ, TD, TYP, YF
Symptoms: Dermatomyositis, Muscular weakness
Clinical narrative: Pt developed dermatomyositis over the few months following her mass vaccines for international travel (see attached history). Dermatomyositis is a rare, very serious autoimmune inflammatory muscle/skin disease. 1/5/10 Ongoing serious autoimmune conditions-deramatologists is still requiring subatartial daily immunoserppriadats (Celliept and Prednisone) as well as IVIg infurine mortally.  06/04/2007 VAERS report submitted with unsigned HPI attached.  Pt. initially experience low grade temps and fatigue for several days following multiple vax for foriegn travel in May 2005.  Upon returning from travel in 8/2005 pt. again experienced low grade temps and fatigue as well as bilateral shoulder and upper arm muscle aches and soreness as well as weakness. Skin flushing and pruritic nodules noted on wrists and elbows. By 9/2005 muscle symptoms and fatigue had increased as well as cuticle changes.  Txd with steroids, IVIG, Minocycline and topical creams to skin. DX: Dermatomyositis.  07/03/2007 MR received from neurologist for several visits beginning 8/28/2005 to 12/08/2005 for initial c/o profound weakness in the arms which was progressing. Pt also c/o hip pain and tightness as well as some skin irritation around the nail cuticle and skin discoloration of the chest area and knees. PE significant for minimal neck flexion weakness as well as minimal biceps/triceps weakness. Knee reflexes depressed. Skin discoloration noted at the cuticles, eyelids, knees.  DX: Dermatomyositis. Pt admitted to hospital 10/23/2005 for increasing weakness, swallowing difficulty and head/neck weakness r/t the dermatomyositis.  F/U 12/8/2005 doing well.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Cyst, Injection site cyst, Injection site pain, Skin lesion
Clinical narrative: L Deltoid area Cyst like lesion 0.5 x 0.5cm + tenderness 5 wks after vaccine placed.
Age: 52.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Cold compress therapy, Erythema, Fatigue, Tenderness
Clinical narrative: Pt. came to visit doctor at clinic 01JUN07 stating that she has been feeling fatigues, having chills and tenderness in arm since last night. Assessment revealed: 3.5 circular erythema on right tricep area. BP: 112/74 P:88bpm. Pt was instructed to take ibuprofen, apply cool compress to area and notify doctor if there is an increase in symptoms by doctor.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness, swelling, and mild discomfort over upper RT deltoid Dad reported temp 102 at home
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema
Clinical narrative: Pt. has red (L) lower deltoid area, no induration noted able to move (L) upper arm
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Dyspnoea, Wheezing
Clinical narrative: 6 hrs after given Menactra developed SOB/wheezing. Used inhaler but wheezing worsened overnite. Was going to use Neb but then improved on own by next day. No rash/fever.
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Left arm 4 1/2 x 6 area red, warm and swollen. Mom says that one of the shots was given almost horizontal not vertical to the skin surface because of all the fighting the child did.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Arm achiness. Arm tender and sore but not visibly swollen or red
Age: 17.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Asthenia, Back pain, Blood test, Fatigue, Headache
Clinical narrative: Patient became ill 1-2 days following vaccines on 5/8/07/. SX: whole body aches, then low back ache, then entire legs aching w/weakness, then calf discomfort with headache and extreme fatigue
Age: 17.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient became ill 1-2 days following vaccines on 5/8/07/. SX: whole body aches, then low back ache, then entire legs aching w/weakness, then calf discomfort with headache and extreme fatigue
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Administered first dose of Rotavirus oral vaccine at 5 months of age, no problems
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: Very tired and sweaty approximately 1:30 at gym - left early - lay down approximately 2 hours - approximately 7:00pm walking in restaurant got very dizzy - thought I would fall - husband grabbed me (never happened before - husband also had shot - he was fine). Felt better next day.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Blood human chorionic gonadotropin increased, Drug exposure during pregnancy
Clinical narrative: Patient was Pregnant at time of vaccine given.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain upper, Alanine aminotransferase normal, Aspartate aminotransferase normal, Back pain, Eosinophil count increased
Clinical narrative: Parent called office on 5/22/07, reported onset of headache and stomach ache on 5/20/07 with increase of head today and c/o spinal pain. Patient was examined on 5/22/07 ---> lab work, afebrile. (H.A. persisted x 1 week)
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Epstein-Barr virus antibody negative, Full blood count normal, Headache, Red blood cell sedimentation rate normal
Clinical narrative: Parent called office on 5/22/07, reported onset of headache and stomach ache on 5/20/07 with increase of head today and c/o spinal pain. Patient was examined on 5/22/07 ---> lab work, afebrile. (H.A. persisted x 1 week)
Age: 84.0
Sex: F
Vaccine: UNK
Symptoms: Body temperature increased, Erythema, Oedema peripheral, Tenderness
Clinical narrative: per patient noted Left upper arm swollen, Red and tender to touch. Noted Wednesday AM. Temperature x 2 nights-Monday and Tuesday up to 101 deg