chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Initial report received from scientific literature on 12 June 2012. The following is verbatim from the article: "Background: Children are at high risk of acquiring and transmitting influenza infection and are a high priority group for INFLUENZA vaccination. Methods: This was a randomized, observer-blind, multicenter study (NCT00980005). Children were randomized (1:1) to receive either the study vaccine, a thimerosal-free trivalent inactivated INFLUENZA vaccine or an active comparator (control vaccine) and were allotted to 1 of 3 age categories: 3-4, 5-8 and 9-17. The primary objective was to show noninferiority of the study vaccine versus licensed control INFLUENZA vaccine. Results: A total of 2116 children were vaccinated (study vaccine N = 1055, control vaccine N = 1061). The predefined noninferiority criteria and the Center for Biologics Evaluation and Research criteria for clinical benefit were met for all 3 seasonal virus strains in all children and each age strata. The ratios of the adjusted geometric mean titers (control vaccine over study vaccine) ranged from 0.93 to 1.03 for the 3 virus strains whereas the differences in seroconversion rate (control vaccine minus study vaccine) were between 22.42% and -1.60%. Post vaccination geometric mean titers (range: 213.7-414.7 versus 200.2-451.9) and seroconversion rates (range: 59.8-81.1% versus 58.2-78.6%) were comparable for the 2 vaccines. The safety and reactogenicity profiles were similar for both treatment groups in all age strata. Conclusions: Immunologic noninferiority of the study vaccine was demonstrated compared with the control vaccine. Furthermore, the study vaccine had a similar safety profile as the control vaccine in children." A "four-year-old male child" received an injection of dose two of FLUZONE, sanofi pasteur Inc., (lot number, route and site not reported on an unspecified date. On an unspecified date later "during the follow-up phase", he developed "insulin-dependent (Type 1) diabetes mellitus", which the investigator considered related to the vaccination. The patient's outcome was reported as not recovered at the conclusion of the study. Documents held by sender: None.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema, Skin warm
Clinical narrative: Mother noticed while being in the air conditioner patients face red. No swelling. No further rash. No difficulty breathing or wheezing. Patient feet were red/hot to the touch. Infection sites warm.
Sex: U
Vaccine: TD
Symptoms: Anaphylactic reaction
Clinical narrative: Initial report was received from a health care professional through another manufacturer on 13 June 2012 under service request number 1-5196539672. A patient, who was 66-years-old at the time of the report, had received an injection of Td  (manufacturer, lot number, route, site and date of administration not reported) about 40 years ago" and an unspecified amount of time later experienced an anaphylactic reaction. Medical history and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: None.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness right upper arm 19 x 22 cm warm to touch, hard to touch treated with AUGMENTIN, BENADRYL; ZYRTEC.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient presented to pharmacy and stated she had a red area at the site of her ZOSTAVAX immunization on 6-12-12. She was immunized on 6-11-12 by Rph. I instructed patient to notify her physician and see him if necessary. Patient saw her physician and returned to pharmacy with instructions for hydrocortisone scream, BENADRYL and EPIPEN. She was consulted extensively on the use of EPIPEN. She return to pharmacy again on 6-14-12 with a prescription for KEFLEX and instructions to use ZANTAC otc by rph on duty on 6-14-12 stated that the red area had spread to patients elbow. The red area on 6-12-12 was approximately 1" by 3" at site of injection.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pruritus
Clinical narrative: Arm (left) that was shot by the vaccine started to itch about 4 hours later, then redness & heat. The arm stayed swollen.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site oedema
Clinical narrative: Inconsolable crying after waking from nap. Left thigh edematous and red from crease of groin to knee.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Heart rate increased, Heart rate irregular, Hypertension, Hypotension
Clinical narrative: Increase pulse rate; irregular heart beat; low/high blood pressure - weakness.
Age: 0.57
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Face oedema, Oedema peripheral, Tongue oedema, Urticaria, Vomiting
Clinical narrative: Pt developed facial, tongue and extremity edema, urticaria & vomiting about 12 hour after imm given. Admitted at hospital for < 1 day. Placed on PO BENADRYL.
Age: 2.0
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised, Rash morbilliform, Vaccination complication
Clinical narrative: 2 weeks after receiving vaccine child woke up with rash foster mother describes it as fine, measles, red rash all over. It progressively got worse & by that night child has covered with rash. Never had fever or any other symptom - only rash. Foster mother took child to convenient care Rx evaluation. Doctor told foster mother it was a reaction to MMR & would go away on its own & to keep out of daycare until 24 hours fever free. 6-17-12 - onset of symptoms. 6-19-12 - took to doctor. 6-21-12 - clearing up (rash).
Age: 0.14
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pentacel injection site reddened, swollen & painful increased crying.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: Pt developed shingles like rash. Clinic NP thinks it is shingles > 72 hours No antiviral tx necessary lesions are healing.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, tenderness & itching on (R) deltoid.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient developed pain in the same distribution as her previous episode of shingles which was sevral years ago.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Child's mother called states that within 10 minutes of receiving vaccine, child c/o headache, nausea and began vomiting. Instructed to take child to his Dr. for follow-up. Parent did not go to Dr. Spoke with her 6-21-12 at 13:10. States child is fine.
Age: 61.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash maculo-papular, Rash vesicular, Urticaria, Varicella post vaccine
Clinical narrative: 4cm X 4cm maculopapular, vesicular lesion at injection site, surrounded by 10cm wheal flare consistent with varicella infection.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: Large, red, warm and painful induration at left shoulder.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site urticaria, Pruritus
Clinical narrative: LESS THAN FIVE MINUTES AFTER VARIVAX WAS ADMINISTERED BEGAN TO ITCH; LOCALIZED HIVE AT SITE. NO RESP SX OBSERVED FOR FIFTEEN MORE MIN. AND GIVEN BY MOUTH ANTIHISTAMINE.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes simplex, Pain in extremity, Rash
Clinical narrative: Patient was diagnosed with herpes whitlow on June 5th. She received injection on May 21. She was treated with acyclovir 400 mg 1 po tid x 10 days. She was also treated with hydrocodone/acetaminophen 5/500 1-2 tabs Q 4-6 hours. She has rash on right arm and pain in right arm. She also had red blisters on right hand, injection given in left arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac disorder, Dizziness, Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: 6-11-12 ZOSTAVAX given at 3:56PM. 6-13-12 Onset of swelling, redness and warmth at site. Told pt to ice it & elevate it. Pt called in AM & said she woke up with her arm swollen, red & warm. She was also dizzy. I told her it was not uncommon to have that rxn (as we had discussed on Monday). I told her I was unsure if dizzy was from that. I told her to ice it & take NSAIDs (since she is on Naproxen). I followed up her approximately 4:30 & she had iced it once. It felt about the same but she did not take Naproxen. I told her to continue with ice & also to elevate it. She was no longer dizzy. 6/14/12 F/U in PM. She said she just returned from hospital. She had problems with her heart. She said they iced the injection site at the hospital. They also elevated it. She said they were not concerned with the swelling & redness from shot, they were worried about her heart. I told her to continue w/ ice & elevation if it didn't get better to follow up with us. She was satisfied with it. Followed up with patient on 6/17/12. She is doing better but still has some swelling and redness at injection site. She stated that she has less swelling and redness than initially. She stated that she went to the hospital Wed 6/13 with shortness of breath, dizziness and palpitations. She stated that she was referred to a cardiologist for follow-up and that the doctor at the hospital thought the heart issues were unrelated to the immunization.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Palpitations
Clinical narrative: 6-11-12 ZOSTAVAX given at 3:56PM. 6-13-12 Onset of swelling, redness and warmth at site. Told pt to ice it & elevate it. Pt called in AM & said she woke up with her arm swollen, red & warm. She was also dizzy. I told her it was not uncommon to have that rxn (as we had discussed on Monday). I told her I was unsure if dizzy was from that. I told her to ice it & take NSAIDs (since she is on Naproxen). I followed up her approximately 4:30 & she had iced it once. It felt about the same but she did not take Naproxen. I told her to continue with ice & also to elevate it. She was no longer dizzy. 6/14/12 F/U in PM. She said she just returned from hospital. She had problems with her heart. She said they iced the injection site at the hospital. They also elevated it. She said they were not concerned with the swelling & redness from shot, they were worried about her heart. I told her to continue w/ ice & elevation if it didn't get better to follow up with us. She was satisfied with it. Followed up with patient on 6/17/12. She is doing better but still has some swelling and redness at injection site. She stated that she has less swelling and redness than initially. She stated that she went to the hospital Wed 6/13 with shortness of breath, dizziness and palpitations. She stated that she was referred to a cardiologist for follow-up and that the doctor at the hospital thought the heart issues were unrelated to the immunization.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Rash
Clinical narrative: IRREGULAR SHAPED RASH LARGER THAN 3 INCHES AND REPORTED 1 COLD SORE ON BOTTOM LIP.
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Blood glucose increased, Injection site erythema, Injection site swelling, Ketonuria, Pyrexia
Clinical narrative: Fever (104), vomiting, swelling and redness around injection site.  She went to Emergency Dept during early AM hours, had ketonuria, treated with IV fluids, and prescribed clindamycin for possible cellulitis.  She continues with ongoing fevers until 6/17/12, with fluctuating redness/swelling of injection site - that was still gradually decreasing on 6/18/12 when I last saw her.  Ketonuria resolved on 6/14/12, blood glucose control acheived on 6/17/12.
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Urine ketone body present, Vomiting
Clinical narrative: Fever (104), vomiting, swelling and redness around injection site.  She went to Emergency Dept during early AM hours, had ketonuria, treated with IV fluids, and prescribed clindamycin for possible cellulitis.  She continues with ongoing fevers until 6/17/12, with fluctuating redness/swelling of injection site - that was still gradually decreasing on 6/18/12 when I last saw her.  Ketonuria resolved on 6/14/12, blood glucose control acheived on 6/17/12.
Age: 31.0
Sex: F
Vaccine: TYP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: NO ADVERSE REACTION- Misadministration of vaccine.  Vaccine expired 5 June 2012.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Tender, raised, red, hot-to-touch lesion on the thigh where the vaccine was given; about the size of a 50 cent piece; overall irritability that lasted about 2 hours but resolved once acetaminophen was given.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Skin lesion
Clinical narrative: Tender, raised, red, hot-to-touch lesion on the thigh where the vaccine was given; about the size of a 50 cent piece; overall irritability that lasted about 2 hours but resolved once acetaminophen was given.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received vaccine (L) deltoid 5/22 - onset swelling, redness, warmth 5/24 - failed oral abx - admitted for IV antibiotics 1 wk after vaccine given.
Age: 66.0
Sex: F
Vaccine: PPV, TD
Symptoms: Muscular weakness
Clinical narrative: Acute leg weakness.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Culture negative, Fluctuance, Incisional drainage, Injection site abscess, Injection site erythema
Clinical narrative: 5/31/12 Patient presented initially 1.5 cm nodule - no erythema and 2.5 cm abscess darkly erythematous to right thigh. On 6/19/12 a small fluctuant abscess central  w/in the 2.5 cm area of erythema on the right thigh. This was I & D with purulent fluid expressed. On 6/12/12 the erythema was smaller but a 1 3/4 cm abscess with fluctuance was I & D.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site nodule, Purulent discharge
Clinical narrative: 5/31/12 Patient presented initially 1.5 cm nodule - no erythema and 2.5 cm abscess darkly erythematous to right thigh. On 6/19/12 a small fluctuant abscess central  w/in the 2.5 cm area of erythema on the right thigh. This was I & D with purulent fluid expressed. On 6/12/12 the erythema was smaller but a 1 3/4 cm abscess with fluctuance was I & D.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, IPV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid redness, swelling, pain and hot skin.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: Nausea, fever, fatigue.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Abasia, Blood test normal, Convulsion, Dysstasia, Nuclear magnetic resonance imaging normal
Clinical narrative: Patient had a seizure about 15 seconds after the second of two vaccinations. Had upper body tremors for approx. 10 hrs. Could not stand or walk for 7 hours (paralyzed).
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Paralysis, Tremor
Clinical narrative: Patient had a seizure about 15 seconds after the second of two vaccinations. Had upper body tremors for approx. 10 hrs. Could not stand or walk for 7 hours (paralyzed).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain, Pruritus, Swelling
Clinical narrative: Sat night - red/swelling. Sun am - itching. Sun pm - little blisters. Wednes - still blistering/itching/pain.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Misadministration of 1st dose of Rota virus vaccine (ROTATEQ) at 6 mnths of age. No reported adverse yet.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Agitation, Dizziness, Syncope, Vomiting
Clinical narrative: Syncope, vomiting, agitation, dizziness 5 min after vaccines.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Pt presented to pharmacy with localized reaction at injection site, which was red, swollen and a little warm to touch. Pt experienced no pain.
Age: 55.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Axillary mass, Injection site swelling, Pyrexia
Clinical narrative: Swelling of (R) arm pit - size of goose egg (noted am 6/21/12). Swelling of (R) deltoid at injection site (noted am 6/20/12). Fever 101 degrees F (noted 6/20/12 pm).
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Patient received a ZOSTAVAX vaccine 5/31, came to pharmacy 6/2 with a baseball-sized, red, rash-like patch that was warm. No pain or fever reported. MD suggested cold compresses and ibuprofen. Pt told to call office Monday AM.
Age: 1.07
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Rash, Rash papular
Clinical narrative: Severe rash with blisters & erythematous papules on extremities mainly. Began the night of immunizations & gradually worsened over the next several days.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Chills, Diarrhoea, Myalgia, Nausea
Clinical narrative: One hour after vaccine patient complained of nausea, fever, chills, diarrhea, myalgias and arthralgias. Presented to Dr on 6/19 for eval - recommended pretreat with ibuprofen and/or BENADRYL prior to next dose.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: One hour after vaccine patient complained of nausea, fever, chills, diarrhea, myalgias and arthralgias. Presented to Dr on 6/19 for eval - recommended pretreat with ibuprofen and/or BENADRYL prior to next dose.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Chills, Diarrhoea, Myalgia, Nausea
Clinical narrative: One hour after vaccine patient complains of nausea, fever, chills, diarrhea, myalgias and arthralgias. Presented to Dr on 6/19 for evaluation. Recommended pretreat with Ibuprofen and/or BENADRYL prior to next dose.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: One hour after vaccine patient complains of nausea, fever, chills, diarrhea, myalgias and arthralgias. Presented to Dr on 6/19 for evaluation. Recommended pretreat with Ibuprofen and/or BENADRYL prior to next dose.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Malaise, Pyrexia
Clinical narrative: Information has been received from a 74 year old female consumer reporting on herself with drug reaction or allergy to "SULFA" who on approximately 13-MAY-2012 ("one month ago"), was vaccinated with ZOSTAVAX (Merck), one injection in both arms (dose, route and lot number not reported). Concomitant medication included "tons of medications". The patient stated it was one injection where she noticed most of the content of the injection was given in one arm and the rest of the injection was administered in the other arm. The patient reported that on approximately 13-MAY-2012 ("one month ago"), she went into anaphylactic shock 10-12 hours after the vaccine was given. The patient also reported that she experienced water in her lungs and fever. The patient called her health care professional to be seen and was treated with steroids, LASIX and potassium. At the time of report the patient's outcome was unknown. Upon internal review, anaphylactic shock was determined to be an other important medical event. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic shock, Pulmonary oedema, Pyrexia, Vaccination error
Clinical narrative: Information has been received from a 74 year old female consumer reporting on herself with drug reaction or allergy to "SULFA" who on approximately 13-MAY-2012 ("one month ago"), was vaccinated with ZOSTAVAX (Merck), one injection in both arms (dose, route and lot number not reported). Concomitant medication included "tons of medications". The patient stated it was one injection where she noticed most of the content of the injection was given in one arm and the rest of the injection was administered in the other arm. The patient reported that on approximately 13-MAY-2012 ("one month ago"), she went into anaphylactic shock 10-12 hours after the vaccine was given. The patient also reported that she experienced water in her lungs and fever. The patient called her health care professional to be seen and was treated with steroids, LASIX and potassium. At the time of report the patient's outcome was unknown. Upon internal review, anaphylactic shock was determined to be an other important medical event. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection, Herpes zoster, Injection site rash
Clinical narrative: Vaccine administered 6/19/12 patient presented w/ shingles rash at site 6/20/12.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Cardiac enzymes increased, Chest pain, Echocardiogram abnormal, Electrocardiogram abnormal, Pericarditis
Clinical narrative: Got shot on Tues. 16, Wed 17, started having chest pain, and stabbing pains came back to clinic, then Thurs. 18, patient was still in pain so I took him to Emergency room --> Dx pericarditis, onset 24 hrs after immuniz.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Fatigue, Herpes zoster, Mobility decreased, Neuralgia
Clinical narrative: On May 7th 2008 I got a shot to prevent getting the shingles. Not sure at this time if I'm running into an adverse reaction or not from the shot. Toward the end of January about the 29th 2012. I started having some pain in the posterior upper "L" arm area which I thought might be due to lifting something improperly. On the morning of Saturday Feb 4th I broke out with a red blotch on middle of "L" chest area and one red blotch on "L" back area and 4 red blotches on inner lower left arm area. Left chest and left arm area achy and I felt very tired. On Feb 5th Sunday rash like area appeared on upper inner "L" arm area and small area on left palm area. I was out of town at the time and on return Feb 7th Tuesday I was back and able to see my primary Dr now. Dr diagnosed my problem as shingles. Have had pain and limited use of "L" arm & hand ever since. At the present time I'm using over the counter medication Acetaminophen 250mg, Aspirin 250mg & caffeine 65mg. So far I've gone for acupuncture 12 times to help relieve the swelling and pain. I'm wondering at this time if I would have been better off not getting the preventative shingle shot. The nerve pain is absolutely unbelievable.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Rash, Rash macular, Swelling
Clinical narrative: On May 7th 2008 I got a shot to prevent getting the shingles. Not sure at this time if I'm running into an adverse reaction or not from the shot. Toward the end of January about the 29th 2012. I started having some pain in the posterior upper "L" arm area which I thought might be due to lifting something improperly. On the morning of Saturday Feb 4th I broke out with a red blotch on middle of "L" chest area and one red blotch on "L" back area and 4 red blotches on inner lower left arm area. Left chest and left arm area achy and I felt very tired. On Feb 5th Sunday rash like area appeared on upper inner "L" arm area and small area on left palm area. I was out of town at the time and on return Feb 7th Tuesday I was back and able to see my primary Dr now. Dr diagnosed my problem as shingles. Have had pain and limited use of "L" arm & hand ever since. At the present time I'm using over the counter medication Acetaminophen 250mg, Aspirin 250mg & caffeine 65mg. So far I've gone for acupuncture 12 times to help relieve the swelling and pain. I'm wondering at this time if I would have been better off not getting the preventative shingle shot. The nerve pain is absolutely unbelievable.
Age: 1.6
Sex: F
Vaccine: DTAP
Symptoms: Bacterial test, Pertussis
Clinical narrative: Pt with completed primary DTaP's administered an alternate schedule at parents request. Pt with confirmed pertussis 6/15/12.*
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Redness, tenderness, hot to touch.
Age: 0.23
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV1
Symptoms: Blood culture negative, Blood electrolytes normal, CSF culture negative, Chest X-ray normal, Culture urine negative
Clinical narrative: Day after vaccines, fever 103.7, mom says his eyes rolled backwards & his body shook EMS transported to Hospital ER. Septic work up neurosonogram - all negative.
Age: 0.23
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV1
Symptoms: Full blood count normal, Gaze palsy, Pyrexia, Respiratory syncytial virus test negative, Tremor
Clinical narrative: Day after vaccines, fever 103.7, mom says his eyes rolled backwards & his body shook EMS transported to Hospital ER. Septic work up neurosonogram - all negative.
Age: 0.23
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV1
Symptoms: Ultrasound scan normal, Urine analysis normal
Clinical narrative: Day after vaccines, fever 103.7, mom says his eyes rolled backwards & his body shook EMS transported to Hospital ER. Septic work up neurosonogram - all negative.
Age: 1.04
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Convulsion, Fatigue, Feeling hot, Pruritus, Tremor
Clinical narrative: Mother said child awoke at approx. 10:45pm 6/21/12 felt "hot". He began to shake. Lasted approx 30 seconds. After he had seizure mother gave him TYLENOL. As of 11am 6-22-12 he had  had only one episode of "shaking". History of one febrile seizure in the past on 5-13-12. Feeling tired & itchy but playing. No loss of consciousness.
Age: 34.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Erythema, Tenderness
Clinical narrative: Developed redness, erythema, tenderness two days. Following SQ injection on left arm. Went to urgent care on 6/9/12 and was treated with Clindamycin x 10 days hospital on 6-15-12 and redness and tenderness was resolving.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin, Blindness unilateral, Herpes zoster, Herpes zoster ophthalmic, Rash erythematous
Clinical narrative: Information has been received from a female consumer reporting on her approximately 65 year old husband with no drug reactions or allergies and no pertinent medical history who on 14-APR-2009, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route, lot number not reported). Concomitant therapy included vitamins (unspecified). In approximately 2011, about 1 year ago, the patient had a red, itchy, burning rash. On approximately 01-MAR-2012, about 4 months ago in the first week of March 2012, the patient developed the shingles in his left eye, his head, his face, mouth and down the left side of his body. Some of the shingles in those areas had gone away. It was also reported that the patient might lose his eyesight and he had no vision in his left eye. At the time of the report the patient's outcome was unknown. Skin biopsy of the rash was performed on an unknown date, results not provided. The patient sought medical attention via visiting the doctor. Upon internal review, no vision in his left eye was determined to be an other important medical event. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Skin burning sensation
Clinical narrative: Information has been received from a female consumer reporting on her approximately 65 year old husband with no drug reactions or allergies and no pertinent medical history who on 14-APR-2009, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route, lot number not reported). Concomitant therapy included vitamins (unspecified). In approximately 2011, about 1 year ago, the patient had a red, itchy, burning rash. On approximately 01-MAR-2012, about 4 months ago in the first week of March 2012, the patient developed the shingles in his left eye, his head, his face, mouth and down the left side of his body. Some of the shingles in those areas had gone away. It was also reported that the patient might lose his eyesight and he had no vision in his left eye. At the time of the report the patient's outcome was unknown. Skin biopsy of the rash was performed on an unknown date, results not provided. The patient sought medical attention via visiting the doctor. Upon internal review, no vision in his left eye was determined to be an other important medical event. Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: MMRV, PPV
Symptoms: Crying, Diet refusal, Irritability, Pyrexia, Rash
Clinical narrative: Fever 102.3 relieved by Tylenol lasted 2 days begining 6/21/12 extreme irritability, unconsolable crying, refusal to eat and a rash that spread from belly to trunk and down arms. He was seen by a physician at his pediatrician who stated it was a vaccine reaction and should resolve on its own. In the evening he appeared to be improving the rash faded, it was faint through the morning of 6/22/12.
Age: 1.04
Sex: M
Vaccine: MMRV, PPV
Symptoms: Vaccination complication
Clinical narrative: Fever 102.3 relieved by Tylenol lasted 2 days begining 6/21/12 extreme irritability, unconsolable crying, refusal to eat and a rash that spread from belly to trunk and down arms. He was seen by a physician at his pediatrician who stated it was a vaccine reaction and should resolve on its own. In the evening he appeared to be improving the rash faded, it was faint through the morning of 6/22/12.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Communication disorder, Convulsion, Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: Initial and follow up information has been received from a physician (M.D.) concerning a 17 year old female patient with none of drug reactions/allergies, Asperger's syndrome, ADD (attention deficit disorder) and legal blindness who on 08-JUN-2011 was vaccinated IM with first 0.5 ml dose of GARDASIL (lot # not available) and on 15-SEP-2011 (also reported as mid-late April of 2012 by the patient's mother) was vaccinated IM with second 0.5 ml dose of GARDASIL (lot # 668262/00841AA). Second suspect therapy included AFLURIA (lot # U4114DA) on 15-SEP-2011. Concomitant therapy included ADDERALL tablets, PROZAC and MENACTRA. The patient's mother explained that her daughter had no issue following her first dose of GARDASIL. Following the patient's second dose of GARDASIL, the patient developed micronic seizures and had a regression of her receptive language which was discovered on Monday 11-JUN-2012. The patient had had some improvement in her receptive language since the discovery however she was still recovering. The patient received this dose of the vaccine with another physician not with her primary care physician. The patient had contacted the 2nd dose administered physician but not to the office. The last time this patient was seen was in the office was in April 2012. EEG and MRI had been performed but no treatment was given. Therapy with GARDASIL will be discontinued for the third dose. At the time of reporting, the patient was recovering. The 2nd dose of vaccine administered physician did not feel the events were due to the GARDASIL. Upon internal review, micronic seizures and regression of her receptive language were considered to be other important medical events. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Headache, Injection site erythema, Lethargy, Malaise, Nausea
Clinical narrative: See attached. Has CPE Friday - got Tdap and ZOSTAVAX. Over the weekend redness at the site increased slightly. Over the weekend began not feeling well with lethargy, nausea - worse today, a real struggle to work. Redness at the site is more. Not itching but used a little cortisone cream. No joint pain, mild HA.
Age: 1.68
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Pallor
Clinical narrative: Left upper thigh covering injection site, 4 in x 5 in circular, blanchable, warm to touch, red lesion, very dense. Minimal swelling, noted after immunization. Worsening since last night. Cephalexin prescribed.
Age: 1.68
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC
Symptoms: Skin lesion
Clinical narrative: Left upper thigh covering injection site, 4 in x 5 in circular, blanchable, warm to touch, red lesion, very dense. Minimal swelling, noted after immunization. Worsening since last night. Cephalexin prescribed.
Age: 0.55
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician's office, concerning an 8 month old male patient who on 08-MAR-2012 was vaccinated with a dose of ROTATEQ (lot number 671576/01240AA) (route, site and dose not provided). Secondary suspect vaccine given on the same day included a dose of RECOMBIVAX HB (lot number, route, site and dose not provided). Concomitant vaccines given on the same day included a dose of PENTACEL and a dose of PREVNAR. It was reported that on an unspecified date the patient was hospitalized for rotavirus. The patient was treated with ZOFRAN and IV fluids. The patient was discharged on 04-MAY-2012. The patient had not been to the physician's office for a follow up visit. At the time of the report, the patient had recovered. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: C-reactive protein increased, Gait disturbance, Headache, Injection site pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 4 year old male patient, with rhinitis allergic and a history of croup and none drug reactions/allergies, who on 26-MAR-2012 was vaccinated with a dose of PEDVAXHIB (lot # 66775/1475AA, expiration date 11-NOV-2012), 0.5ml, IM in left thigh. Concomitant therapy included a dose of PREVNAR vaccinated on 26-MAR-2012 in right thigh. It was reported that on 27-MAR-2012 the patient developed a fever of 101 Fahrenheit with a headache. The patient's parent called the office and was advised to administer MOTRIN or TYLENOL. On unknown date the symptoms resolved. On 05-APR-2012 the patient's parents called the office to report the patient had developed fever, left thigh soreness and limping. Nurse reported that the patient was seen in the office on 06-APR-2012 and was found to have an elevated white blood cell count and C-reactive protein level. On the same day, 06-APR-2012, the patient was admitted to the hospital. On unknown date the patient had a magnetic resonance imaging (MRI) and was diagnosed with left femoral osteomyelitis. A peripherally inserted catheter was inserted and the patient was started on IV antibiotics (unspecified type). The patient was discharged from the hospital on 10-APR-2012. The patient continued IV antibiotics therapy at home. On 26-APR-2012 the antibiotics and peripherally inserted central cathered ("PIC line") were discontinued. On 26-APR-2012 the patient recovered. Left femoral osteomyelitis was considered to be disabling, immediately life-threatening and other important medical event by the reporting nurse. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Osteomyelitis, Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 4 year old male patient, with rhinitis allergic and a history of croup and none drug reactions/allergies, who on 26-MAR-2012 was vaccinated with a dose of PEDVAXHIB (lot # 66775/1475AA, expiration date 11-NOV-2012), 0.5ml, IM in left thigh. Concomitant therapy included a dose of PREVNAR vaccinated on 26-MAR-2012 in right thigh. It was reported that on 27-MAR-2012 the patient developed a fever of 101 Fahrenheit with a headache. The patient's parent called the office and was advised to administer MOTRIN or TYLENOL. On unknown date the symptoms resolved. On 05-APR-2012 the patient's parents called the office to report the patient had developed fever, left thigh soreness and limping. Nurse reported that the patient was seen in the office on 06-APR-2012 and was found to have an elevated white blood cell count and C-reactive protein level. On the same day, 06-APR-2012, the patient was admitted to the hospital. On unknown date the patient had a magnetic resonance imaging (MRI) and was diagnosed with left femoral osteomyelitis. A peripherally inserted catheter was inserted and the patient was started on IV antibiotics (unspecified type). The patient was discharged from the hospital on 10-APR-2012. The patient continued IV antibiotics therapy at home. On 26-APR-2012 the antibiotics and peripherally inserted central cathered ("PIC line") were discontinued. On 26-APR-2012 the patient recovered. Left femoral osteomyelitis was considered to be disabling, immediately life-threatening and other important medical event by the reporting nurse. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: See office note from PCP.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: See office note from PCP.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Completed suicide, Death, Gun shot wound
Clinical narrative: Information has been received from a physician concerning a 14 year old male with no pertinent medical history and no drug allergies who was vaccinated intramuscularly with the first and second 0.5ml dose of GARDASIL (Lot# not reported) respectively on 02-APR-2012 and 04-JUN-2012. There was no concomitant medication. On 07-JUN-2012 the patient committed suicide. He shot himself in head. Physician stated this young male was happy go lucky, healthy, and never had any psychiatric issues in the past. It was not known if the patient sought for medical attention. On 07-JUN-2012 the patient died of suicide. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Nausea, Presyncope, Visual impairment
Clinical narrative: Near syncopal episode, with nausea, dizziness, and change in vision lasting 5 mins. Pt was placed in reclined position and given water to drink.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Convulsion, Syncope
Clinical narrative: Syncopal episode followed by seizure x 2.
Sex: F
Vaccine: HPV4
Symptoms: Foetal disorder, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a consumer, a Medical Assistant and a practice administrator concerning baby who was born from an 18 year old female patient with asthma, dyslexia and drug intolerance to BENADRYL and to AUGMENTIN, and who on 20-MAY-2011 was vaccinated with her first dose of GARDASIL (lot number 666597/0768Z) (dose, route and site not provided). On the same day the patient also received a dose of VARIVAX (lot number, dose, route and site not provided), a dose of MENACTRA and a dose of Tdap. On 22-JUL-2011, the patient received the second dose of GARDASIL (lot # 0819Z) (dose, route and site not provided). The patient did not receive any other vaccinations that day. On 23-Dec-2011, the patient received the third dose of GARDASIL (lot # 670048/0963AA) (dose, route and site not provided). The patient did not receive any other vaccinations that day. The patient's mother was pregnant at the time she received her third and last dose of GARDASIL. It was reported that the baby was born and had hydrocephalia. The patient's mother did not provide any information about her baby. It was reported that the baby may had been hospitalized at that time. At the time of the report the patient's outcome was unknown. The mother's events were captured in WAES # 1206USA02525. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Pain in extremity, Rash
Clinical narrative: Left arm pain and swelling around injection site. Rash on arms and legs.
Age: 38.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chest X-ray, Chills, Cough, Full blood count, Headache
Clinical narrative: A lot of arm pain, aches, 102 fever, chills, cough, headache - went to ER 6/21/12 - given VICODIN, ZITHROMAX.
Age: 38.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: A lot of arm pain, aches, 102 fever, chills, cough, headache - went to ER 6/21/12 - given VICODIN, ZITHROMAX.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase MB, C-reactive protein, Chest pain, Chills, Ejection fraction normal
Clinical narrative: The pt received his primary SPV in the left upper arm on 5/22/12. He was in his normal state of good health at the time. About 2 days later he noticed that he was fatigued. On day 3 he noted generalize muscle aches and axillary and cervical lymphadenopathy. On day 7 he felt feverish and chilled-he did not seek medical attention nor did he miss any work days. Additionally, on 5/29/12 (day 7) he noted a 2 minute episode of left sided dull, non-radiating, chest pain (2/10) while at rest. The pt denied N, V, SOB or diaphoresis. He thought that might have "heartburn" as he had eaten fried food for dinner (the pt denies prior hx of "heartburn"). The symptoms resolved without treatment. The pt experienced a second episode of substernal chest pain (4/10) while resting on 6/2/12. The pain lasted about 10 minutes and radiated from the sternum to the anterior chest. It resolved without treatment. He denied any other symptoms (N, V, diaphoresis, SOB). On 6/11/12 around 10 am while at work he noted 10/10 severe substernal chest "pressure" which improved leaning forward and worsened with leaning back. He was diaphoretic and nauseated (he denied V, SOB, or palpitations). The pt stated that the pain radiated to both arms intermittently. The pt reported to the ER. He had a normal PE (no murmur, no chest tenderness). He was given MOTRIN at 1100 with improvement of his chest pain (5/10) after about 90 minutes. The EKG showed NSR with early repolarization. CSR results are below. He was diagnosed with pericarditis and he was started on NAPROSYN 500 mg bid. He was seen in Cardiology Clinic on 6/18/12 where he reported that he continues to experience substernal chest pressure which lasts about 2 minutes and occurs about 2 minutes and occurs about 3 time per day (unrelated to activity). He had an EKG which showed NSR and a normal ECHO. He was diagnosed with atypical chest pain; instructed to continue NAPROSYN bid for 2 more weeks; stress echo will be considered if pain continues or worsens.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram abnormal, Electrocardiogram repolarisation abnormality, Fatigue, Hyperhidrosis, Lymphadenopathy
Clinical narrative: The pt received his primary SPV in the left upper arm on 5/22/12. He was in his normal state of good health at the time. About 2 days later he noticed that he was fatigued. On day 3 he noted generalize muscle aches and axillary and cervical lymphadenopathy. On day 7 he felt feverish and chilled-he did not seek medical attention nor did he miss any work days. Additionally, on 5/29/12 (day 7) he noted a 2 minute episode of left sided dull, non-radiating, chest pain (2/10) while at rest. The pt denied N, V, SOB or diaphoresis. He thought that might have "heartburn" as he had eaten fried food for dinner (the pt denies prior hx of "heartburn"). The symptoms resolved without treatment. The pt experienced a second episode of substernal chest pain (4/10) while resting on 6/2/12. The pain lasted about 10 minutes and radiated from the sternum to the anterior chest. It resolved without treatment. He denied any other symptoms (N, V, diaphoresis, SOB). On 6/11/12 around 10 am while at work he noted 10/10 severe substernal chest "pressure" which improved leaning forward and worsened with leaning back. He was diaphoretic and nauseated (he denied V, SOB, or palpitations). The pt stated that the pain radiated to both arms intermittently. The pt reported to the ER. He had a normal PE (no murmur, no chest tenderness). He was given MOTRIN at 1100 with improvement of his chest pain (5/10) after about 90 minutes. The EKG showed NSR with early repolarization. CSR results are below. He was diagnosed with pericarditis and he was started on NAPROSYN 500 mg bid. He was seen in Cardiology Clinic on 6/18/12 where he reported that he continues to experience substernal chest pressure which lasts about 2 minutes and occurs about 2 minutes and occurs about 3 time per day (unrelated to activity). He had an EKG which showed NSR and a normal ECHO. He was diagnosed with atypical chest pain; instructed to continue NAPROSYN bid for 2 more weeks; stress echo will be considered if pain continues or worsens.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Myalgia, Nausea, Pain in extremity, Pericarditis, Pyrexia
Clinical narrative: The pt received his primary SPV in the left upper arm on 5/22/12. He was in his normal state of good health at the time. About 2 days later he noticed that he was fatigued. On day 3 he noted generalize muscle aches and axillary and cervical lymphadenopathy. On day 7 he felt feverish and chilled-he did not seek medical attention nor did he miss any work days. Additionally, on 5/29/12 (day 7) he noted a 2 minute episode of left sided dull, non-radiating, chest pain (2/10) while at rest. The pt denied N, V, SOB or diaphoresis. He thought that might have "heartburn" as he had eaten fried food for dinner (the pt denies prior hx of "heartburn"). The symptoms resolved without treatment. The pt experienced a second episode of substernal chest pain (4/10) while resting on 6/2/12. The pain lasted about 10 minutes and radiated from the sternum to the anterior chest. It resolved without treatment. He denied any other symptoms (N, V, diaphoresis, SOB). On 6/11/12 around 10 am while at work he noted 10/10 severe substernal chest "pressure" which improved leaning forward and worsened with leaning back. He was diaphoretic and nauseated (he denied V, SOB, or palpitations). The pt stated that the pain radiated to both arms intermittently. The pt reported to the ER. He had a normal PE (no murmur, no chest tenderness). He was given MOTRIN at 1100 with improvement of his chest pain (5/10) after about 90 minutes. The EKG showed NSR with early repolarization. CSR results are below. He was diagnosed with pericarditis and he was started on NAPROSYN 500 mg bid. He was seen in Cardiology Clinic on 6/18/12 where he reported that he continues to experience substernal chest pressure which lasts about 2 minutes and occurs about 2 minutes and occurs about 3 time per day (unrelated to activity). He had an EKG which showed NSR and a normal ECHO. He was diagnosed with atypical chest pain; instructed to continue NAPROSYN bid for 2 more weeks; stress echo will be considered if pain continues or worsens.