chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Myalgia, Pain in extremity, Rash
Clinical narrative: Received ZOSTAVAX on 3/22/2012 and 4 days later had arm soreness with shooting pains (10/10) that awakened her at night. Had red lump at site for a week and malaise. That resolved and she developed sneezing and asthma symptoms. Treated with injected steroid and asthma symptoms relieved along pain, but the arm pain returned as bad as before. The pain persists at 5/10. No loss of motor function. Her husband had a similar reaction, but his resolved after two months.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthma, Condition aggravated, Injection site erythema, Injection site mass, Malaise
Clinical narrative: Received ZOSTAVAX on 3/22/2012 and 4 days later had arm soreness with shooting pains (10/10) that awakened her at night. Had red lump at site for a week and malaise. That resolved and she developed sneezing and asthma symptoms. Treated with injected steroid and asthma symptoms relieved along pain, but the arm pain returned as bad as before. The pain persists at 5/10. No loss of motor function. Her husband had a similar reaction, but his resolved after two months.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Sneezing
Clinical narrative: Received ZOSTAVAX on 3/22/2012 and 4 days later had arm soreness with shooting pains (10/10) that awakened her at night. Had red lump at site for a week and malaise. That resolved and she developed sneezing and asthma symptoms. Treated with injected steroid and asthma symptoms relieved along pain, but the arm pain returned as bad as before. The pain persists at 5/10. No loss of motor function. Her husband had a similar reaction, but his resolved after two months.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site discolouration, Injection site induration, Injection site reaction, Irritability, Pallor
Clinical narrative: Fever that went up to 104.4, rectally.  Extreme fussiness, rash consisting of scattered blanching pink papules over her body, mainly on trunk and face.  Also significant bluish-red discoloration that is indurated and about 3 x 4 cm at the vaccination injection site.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: Fever that went up to 104.4, rectally.  Extreme fussiness, rash consisting of scattered blanching pink papules over her body, mainly on trunk and face.  Also significant bluish-red discoloration that is indurated and about 3 x 4 cm at the vaccination injection site.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm, Urticaria
Clinical narrative: Left arm swelling, red raised hives, warm to touch, itching.
Age: 0.99
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2012US010030 is an initial spontaneous report received from a medical assistant on 20 Apr 2012 with a follow up information received on 02 Jul 2012: This case refers to 11-months-old male patient. He was inadvertently vaccinated with MENVEO (batch number: X10057, expiry date: Feb 2013) at dose of 0.5 ml, intramuscularly on 20 Apr 2012. It was reported that MENVEO was given in error in place of MMR (batch number: not reported) vaccine. He was hospitalized on an unspecified date. No adverse event was reported following this administration error. No further information was available. Follow up information received on 02 Jul 2012: Patient demographics (height and weight) updated, MMR coded as suspect product, wrong vaccine administered coded as event, seriousness criterion was updated.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient called pharmacy with 1" -2" rash on injection site. Patient called pharmacy on 7/5/12 and received vaccine on 7/3/12. Dr wants to see patient in the morning.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Pt. received vaccine and had blood drawn. Sat in waiting room about 15 min. after administration. Left with mother and family. Fainted on street outside clinic. Family brought back in to clinic. Recovered quickly.
Age: 4.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Decreased appetite, Fatigue, Pyrexia, Vomiting
Clinical narrative: Vomited 7/2/12. Fatigue, no appetite, fever on 7/1/12.
Sex: F
Vaccine: FLU3
Symptoms: Constipation, Eye pain, Eyelid oedema, Headache, Nausea
Clinical narrative: Swelling in face, at eyes, (R) eye pain, HA, nausea, constipation, rash pain for 1 week.
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash, Swelling face
Clinical narrative: Swelling in face, at eyes, (R) eye pain, HA, nausea, constipation, rash pain for 1 week.
Age: 25.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: Red swollen area around where the shot was given. Bruised in the middle. Some pain similar to what it felt like when the shot was given.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Pyrexia
Clinical narrative: Administered DTaP/IPV/HepB (Pediarix); ActHib on 5/22/2012, developped a temp of 102 on 5/24/2012 and then rose to 104.6 on 5/26/2012 which did not resolve for "several hours" with Tylenol provided every four hours. Mother stated no other signs of acute illness, just a "high temp".
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Asthenia, Condition aggravated, Epistaxis, Fibromyalgia
Clinical narrative: Fever & soreness, redness at site of injection, general all-over flu-like symptoms from time of injection until about 1 week later. Then, I had migraine headaches and nosebleed for a week. Then strep throat, and more severe flu-like symptoms set in and lasted about 2 weeks. Serious loss of stamina, and now having a major and painful, debilitating episode of fibromyalgia that has seriously limited my activities. FMS had been under good control for about 10 yrs, until this. I also have continuing PHN at site of injection.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Migraine, Pharyngitis streptococcal
Clinical narrative: Fever & soreness, redness at site of injection, general all-over flu-like symptoms from time of injection until about 1 week later. Then, I had migraine headaches and nosebleed for a week. Then strep throat, and more severe flu-like symptoms set in and lasted about 2 weeks. Serious loss of stamina, and now having a major and painful, debilitating episode of fibromyalgia that has seriously limited my activities. FMS had been under good control for about 10 yrs, until this. I also have continuing PHN at site of injection.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever & soreness, redness at site of injection, general all-over flu-like symptoms from time of injection until about 1 week later. Then, I had migraine headaches and nosebleed for a week. Then strep throat, and more severe flu-like symptoms set in and lasted about 2 weeks. Serious loss of stamina, and now having a major and painful, debilitating episode of fibromyalgia that has seriously limited my activities. FMS had been under good control for about 10 yrs, until this. I also have continuing PHN at site of injection.
Age: 11.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Dizziness, Gaze palsy, Loss of consciousness, Pallor, Skin discolouration
Clinical narrative: Face got very pale, eyes rolled back and she began tongue rolling and passed out for approximately 10 seconds. Skin around mouth turned green and she remained pale for approx 10 min. She was light-headed for approx 30 min and came home (20 min drive) and went to sleep for about an hour.
Age: 11.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Tongue disorder
Clinical narrative: Face got very pale, eyes rolled back and she began tongue rolling and passed out for approximately 10 seconds. Skin around mouth turned green and she remained pale for approx 10 min. She was light-headed for approx 30 min and came home (20 min drive) and went to sleep for about an hour.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Received ZOSTAVAX vaccine on 7/3/12. Pt noticed her arm swelled to 4" x 4" and was itchy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Large local reaction at injection site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Electrocardiogram QT prolonged, Electrocardiogram abnormal, Electroencephalogram normal, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Immediately after MCV injection, patient passed out and had seizure-like posturing for approximately 5 minutes. He was able to sit up but immediately passed out again. After 25 minutes, he was not able to return to "normal" and an ambulance was called.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Seizure like phenomena
Clinical narrative: Immediately after MCV injection, patient passed out and had seizure-like posturing for approximately 5 minutes. He was able to sit up but immediately passed out again. After 25 minutes, he was not able to return to "normal" and an ambulance was called.
Age: 93.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site swelling, Pain in extremity
Clinical narrative: Pt returned to the clinic on 6-13-12 with pain and swelling in the left arm which started the day after receiving Tdap vaccine. The swelling was in the area of the injection site. Pt had difficulty with range of motion of the left arm.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Fall, Presyncope
Clinical narrative: Child had near syncope minutes after receiving vaccination. Stool up from sitting position walked over to check out, became light headed and fell. No LOC. Taken back to examining room. HR: 60 BP: 100/60 was given water, observed 20 minutes. Fully recovered.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Diarrhoea, Injection site nodule, Injection site pain, Pyrexia
Clinical narrative: On 6-28-12 at 9:00, tender nodule at injection site lateral (L) leg, 2 x 3 cm  duration 2 - 3 days, (diarrhea x 1 day) fever from 6/19/12 until 6-23-12, up to 100.0 degrees. Treatment, SEPTRA 40 mg/5 cc, 1 1/4 tsp PO BID x 10 days.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Differential white blood cell count, Full blood count, Injection site erythema, Injection site pain
Clinical narrative: The day after injection the area was a little red and sore - it progressively has gotten bigger.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Abscess, Cellulitis, Injection site erythema, Injection site swelling, Vaccination complication
Clinical narrative: Pt was noted to have swelling and erythema near but not on the injection site the same day after receiving the injection. Pt came to clinic 2 days later and was diagnosed with Cellulitis/abscess likely related to the injection. Pt was prescribed a 10 day regimen of Keflex.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Neurological examination
Clinical narrative: Transient weakness of right leg, onset approx 10pm, went to bed approx 11pm still with weakness, awoke next morning feeling just fine.
Age: 0.27
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Diet refusal, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Inconsolable crying as though she were in pain; swelling, redness, and hot at the injection site, sore leg.  Crying lasted almost 3 hours until she fell asleep.  Gave her infant Tylenol around 7pm.  She was not interested in eating much for about 24 hours after the injection.  Lethargic and sore the next day. Still sore the 3rd day.
Age: 0.27
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Lethargy, Pain, Pain in extremity
Clinical narrative: Inconsolable crying as though she were in pain; swelling, redness, and hot at the injection site, sore leg.  Crying lasted almost 3 hours until she fell asleep.  Gave her infant Tylenol around 7pm.  She was not interested in eating much for about 24 hours after the injection.  Lethargic and sore the next day. Still sore the 3rd day.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt's left deltoid got swollen, red, and firm and hot to touch; got worse overnight.  Pt given Benadryl in office for this.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Headache, Hypoacusis, Vision blurred
Clinical narrative: Head ache, dizziness, blurred vision, muffled hearing.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Throat tightness, Vision blurred
Clinical narrative: Weakness, dizziness, pressure on throat, blurred vision.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Right deltoid pain and swelling.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: Large hard knot in arm in area shot was given (size of 1.5 golf balls). Redness and warmth along tricep area in arm the shot was given.
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: Crying, Dyskinesia, Gaze palsy, Muscle spasms
Clinical narrative: "Crying for 1 hour, muscle spasms, rolling eyes in the back of head while arm jerk toward body".
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Burning sensation, Cellulitis, Erythema, Herpes zoster
Clinical narrative: While the Pneumovax vaccine was being administered, there was immediate excruciating pain lateral and anterior to the injection site (which was an IM injection in L Deltoid). The burning and stinging pain was felt primarily in the axillary region at the anterior fold, not at the site of the injection. Thinking the pain would pass and that it may have been expected, I went forward with the discharge immediately after the injection under the assumption it would clear up on it's own. It did not. When I arrived home my left upper arm and axillary area became even more sore and the burning sensation and tenderness increased. At this time an area of redness began to appear at the axillary area where the pain was felt during the injection. Again, this was not at the direct point of the injection, but lateral and at axillary region. Knowing that some tenderness is to be expected, I just watched the site. On 7/5/2012, the site became more inflamed and the area of induration, heat, and redness began to increase, I continued to watch it until today, 7/6/12. This morning, 7/6/12, I contacted Dr. at 10:30 am and left message and then again later in the afternoon when he was able to talk. He directed me to go immediately to the ER. I arrived at the ER around 2:30/3pm and was seen by Dr. who refused to document what was happening to me as a reaction to the  vaccine. She stated that she did not believe it was related to the vaccine and stated that she thought it was shingles. I explained to her that I am a Nurse Practitioner and know the difference between shingles and an acute reaction to a vaccination.  I suggested that thrombophlebitis be ruled out, as I was also taking Dysteda and the pain came on fairly quickly. If thrombosis was ruled out, then cellulitis would be good differential.  She became upset when I questioned her diagnosis of shingles. After contesting the diagnosis, she agreed to have a venous Doppler which was negative, and then gave me Augmentin 875 mg one tablet by mouth twice daily for five days. She stated "Rash" on discharge. And denied up until discharge that my soreness, inflammation, induration, and warmth were a reaction to vaccine. I photo documented the site from the night I got home until the ER visit, yet she ignored this information. Now it is 9:29 PM 7/6/12, I have had one dose of Augmentin. The area of induration is confluent, indurated, red and growing, and pain is progressively working its way up my shoulder. This has been a very upsetting experience. I am not concerned with blaming anyone. I am a proponent of vaccinations, but when an adverse event occurs, it is important to document and follow up, which this hospital and physician refused to do. Normally, a CBC would be drawn and the area circled with a surgical marker. This was just a disappointing experience. I will f/u as symptoms progress or heal.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Induration, Injection site inflammation, Injection site pain, Musculoskeletal pain
Clinical narrative: While the Pneumovax vaccine was being administered, there was immediate excruciating pain lateral and anterior to the injection site (which was an IM injection in L Deltoid). The burning and stinging pain was felt primarily in the axillary region at the anterior fold, not at the site of the injection. Thinking the pain would pass and that it may have been expected, I went forward with the discharge immediately after the injection under the assumption it would clear up on it's own. It did not. When I arrived home my left upper arm and axillary area became even more sore and the burning sensation and tenderness increased. At this time an area of redness began to appear at the axillary area where the pain was felt during the injection. Again, this was not at the direct point of the injection, but lateral and at axillary region. Knowing that some tenderness is to be expected, I just watched the site. On 7/5/2012, the site became more inflamed and the area of induration, heat, and redness began to increase, I continued to watch it until today, 7/6/12. This morning, 7/6/12, I contacted Dr. at 10:30 am and left message and then again later in the afternoon when he was able to talk. He directed me to go immediately to the ER. I arrived at the ER around 2:30/3pm and was seen by Dr. who refused to document what was happening to me as a reaction to the  vaccine. She stated that she did not believe it was related to the vaccine and stated that she thought it was shingles. I explained to her that I am a Nurse Practitioner and know the difference between shingles and an acute reaction to a vaccination.  I suggested that thrombophlebitis be ruled out, as I was also taking Dysteda and the pain came on fairly quickly. If thrombosis was ruled out, then cellulitis would be good differential.  She became upset when I questioned her diagnosis of shingles. After contesting the diagnosis, she agreed to have a venous Doppler which was negative, and then gave me Augmentin 875 mg one tablet by mouth twice daily for five days. She stated "Rash" on discharge. And denied up until discharge that my soreness, inflammation, induration, and warmth were a reaction to vaccine. I photo documented the site from the night I got home until the ER visit, yet she ignored this information. Now it is 9:29 PM 7/6/12, I have had one dose of Augmentin. The area of induration is confluent, indurated, red and growing, and pain is progressively working its way up my shoulder. This has been a very upsetting experience. I am not concerned with blaming anyone. I am a proponent of vaccinations, but when an adverse event occurs, it is important to document and follow up, which this hospital and physician refused to do. Normally, a CBC would be drawn and the area circled with a surgical marker. This was just a disappointing experience. I will f/u as symptoms progress or heal.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Rash, Skin warm, Tenderness, Ultrasound Doppler normal
Clinical narrative: While the Pneumovax vaccine was being administered, there was immediate excruciating pain lateral and anterior to the injection site (which was an IM injection in L Deltoid). The burning and stinging pain was felt primarily in the axillary region at the anterior fold, not at the site of the injection. Thinking the pain would pass and that it may have been expected, I went forward with the discharge immediately after the injection under the assumption it would clear up on it's own. It did not. When I arrived home my left upper arm and axillary area became even more sore and the burning sensation and tenderness increased. At this time an area of redness began to appear at the axillary area where the pain was felt during the injection. Again, this was not at the direct point of the injection, but lateral and at axillary region. Knowing that some tenderness is to be expected, I just watched the site. On 7/5/2012, the site became more inflamed and the area of induration, heat, and redness began to increase, I continued to watch it until today, 7/6/12. This morning, 7/6/12, I contacted Dr. at 10:30 am and left message and then again later in the afternoon when he was able to talk. He directed me to go immediately to the ER. I arrived at the ER around 2:30/3pm and was seen by Dr. who refused to document what was happening to me as a reaction to the  vaccine. She stated that she did not believe it was related to the vaccine and stated that she thought it was shingles. I explained to her that I am a Nurse Practitioner and know the difference between shingles and an acute reaction to a vaccination.  I suggested that thrombophlebitis be ruled out, as I was also taking Dysteda and the pain came on fairly quickly. If thrombosis was ruled out, then cellulitis would be good differential.  She became upset when I questioned her diagnosis of shingles. After contesting the diagnosis, she agreed to have a venous Doppler which was negative, and then gave me Augmentin 875 mg one tablet by mouth twice daily for five days. She stated "Rash" on discharge. And denied up until discharge that my soreness, inflammation, induration, and warmth were a reaction to vaccine. I photo documented the site from the night I got home until the ER visit, yet she ignored this information. Now it is 9:29 PM 7/6/12, I have had one dose of Augmentin. The area of induration is confluent, indurated, red and growing, and pain is progressively working its way up my shoulder. This has been a very upsetting experience. I am not concerned with blaming anyone. I am a proponent of vaccinations, but when an adverse event occurs, it is important to document and follow up, which this hospital and physician refused to do. Normally, a CBC would be drawn and the area circled with a surgical marker. This was just a disappointing experience. I will f/u as symptoms progress or heal.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: While the Pneumovax vaccine was being administered, there was immediate excruciating pain lateral and anterior to the injection site (which was an IM injection in L Deltoid). The burning and stinging pain was felt primarily in the axillary region at the anterior fold, not at the site of the injection. Thinking the pain would pass and that it may have been expected, I went forward with the discharge immediately after the injection under the assumption it would clear up on it's own. It did not. When I arrived home my left upper arm and axillary area became even more sore and the burning sensation and tenderness increased. At this time an area of redness began to appear at the axillary area where the pain was felt during the injection. Again, this was not at the direct point of the injection, but lateral and at axillary region. Knowing that some tenderness is to be expected, I just watched the site. On 7/5/2012, the site became more inflamed and the area of induration, heat, and redness began to increase, I continued to watch it until today, 7/6/12. This morning, 7/6/12, I contacted Dr. at 10:30 am and left message and then again later in the afternoon when he was able to talk. He directed me to go immediately to the ER. I arrived at the ER around 2:30/3pm and was seen by Dr. who refused to document what was happening to me as a reaction to the  vaccine. She stated that she did not believe it was related to the vaccine and stated that she thought it was shingles. I explained to her that I am a Nurse Practitioner and know the difference between shingles and an acute reaction to a vaccination.  I suggested that thrombophlebitis be ruled out, as I was also taking Dysteda and the pain came on fairly quickly. If thrombosis was ruled out, then cellulitis would be good differential.  She became upset when I questioned her diagnosis of shingles. After contesting the diagnosis, she agreed to have a venous Doppler which was negative, and then gave me Augmentin 875 mg one tablet by mouth twice daily for five days. She stated "Rash" on discharge. And denied up until discharge that my soreness, inflammation, induration, and warmth were a reaction to vaccine. I photo documented the site from the night I got home until the ER visit, yet she ignored this information. Now it is 9:29 PM 7/6/12, I have had one dose of Augmentin. The area of induration is confluent, indurated, red and growing, and pain is progressively working its way up my shoulder. This has been a very upsetting experience. I am not concerned with blaming anyone. I am a proponent of vaccinations, but when an adverse event occurs, it is important to document and follow up, which this hospital and physician refused to do. Normally, a CBC would be drawn and the area circled with a surgical marker. This was just a disappointing experience. I will f/u as symptoms progress or heal.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Felt faint after GARDASIL. BP 88/40. Appeared pale and diaphoretic. Given juice, layed down BP 90/58. Color improved after 15 mins. Released from office.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Induration, Local reaction, Pruritus, Type III immune complex mediated reaction
Clinical narrative: Per provider, patient had a type 4 hypersensitivity reaction, local Arthus reaction. Per provider, this was not a cellulitis.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Had GARDASIL and felt nausea and fait. Had not eaten in am. Gave juice, felt much better, released after 20 mins.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented w/ redness, swelling in large area, surrounding injection site. Hot to touch & painful. Was going to ice & use BENADRYL.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash erythematous
Clinical narrative: Small red bump - slight itching - redness spreading. MD treating with KEFLEX 500mg QID x 10days and OTC BENADRYL.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Joint stiffness, Nausea, Vomiting
Clinical narrative: Reported joint pain & stiffness throughout entire body within 48 hours of receiving vaccine. Also reported nausea & vomiting without fever 6 days after receiving Tdap vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: Redness and itching at site. Fever and chills.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: Pt. got a secondary ZOSTAVAX shot in 2012. Pt. was vaccinated of ZOSTAVAX in 2010. Maybe pt. forgot.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Immediate syncopal episode lasting few seconds.
Age: 10.0
Sex: M
Vaccine: TYP, YF
Symptoms: Dyspnoea, Urticaria
Clinical narrative: About 30 minutes - 1 hr after vaccine administration he developed generalized hives, and difficulty breathing. He was taken to a quick care and given BENADRYL steroid and respiratory treatments, as well as oxygen. It is unknown if epi was given.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching at site of injection, red. Recommend cold compresses and BENADRYL on 7/5/12. On 7/6/12 - pt. says swelling, redness decreased, area stops itching. Did not take BENADRYL.
Age: 1.59
Sex: F
Vaccine: MMR
Symptoms: Cough, Crying, Diarrhoea, Eye swelling, Irritability
Clinical narrative: She woke up with a 103 fever followed by a red rash on her face later in the day. Over the next day the rash spread to cover her whole face, back, abdomen, some on her arms and eventually down her legs and even the bottoms of her feet. On the second day, her eyes swelled and were bloodshot (resembling a severe case of pinkeye). She started coughing, had a runny nose, and continued with diarrhea (7-8 times a day) for approximately five days. A few of the rash lesions scabbed from her scratching but most faded away over time.  One seems to have left a scar, and another is still healing but looks likely to leave a bit of a scar on her thigh as it is fairly large.  She was extremely irritable, awakening during the night many time screaming and crying for an hour or more at a time, for about 5 nights. Today is day 8, and she has now spiked a 104 temp again, but as the rash has faded, I am unsure if she has a secondary infection or if she is simply coming down with some other viral illness. Her twin brother had a similar course of illness with immunization on the same day with a slighly less severe rash.
Age: 1.59
Sex: F
Vaccine: MMR
Symptoms: Middle insomnia, Ocular hyperaemia, Pyrexia, Rash erythematous, Rhinorrhoea
Clinical narrative: She woke up with a 103 fever followed by a red rash on her face later in the day. Over the next day the rash spread to cover her whole face, back, abdomen, some on her arms and eventually down her legs and even the bottoms of her feet. On the second day, her eyes swelled and were bloodshot (resembling a severe case of pinkeye). She started coughing, had a runny nose, and continued with diarrhea (7-8 times a day) for approximately five days. A few of the rash lesions scabbed from her scratching but most faded away over time.  One seems to have left a scar, and another is still healing but looks likely to leave a bit of a scar on her thigh as it is fairly large.  She was extremely irritable, awakening during the night many time screaming and crying for an hour or more at a time, for about 5 nights. Today is day 8, and she has now spiked a 104 temp again, but as the rash has faded, I am unsure if she has a secondary infection or if she is simply coming down with some other viral illness. Her twin brother had a similar course of illness with immunization on the same day with a slighly less severe rash.
Age: 1.59
Sex: F
Vaccine: MMR
Symptoms: Scab, Scar, Screaming
Clinical narrative: She woke up with a 103 fever followed by a red rash on her face later in the day. Over the next day the rash spread to cover her whole face, back, abdomen, some on her arms and eventually down her legs and even the bottoms of her feet. On the second day, her eyes swelled and were bloodshot (resembling a severe case of pinkeye). She started coughing, had a runny nose, and continued with diarrhea (7-8 times a day) for approximately five days. A few of the rash lesions scabbed from her scratching but most faded away over time.  One seems to have left a scar, and another is still healing but looks likely to leave a bit of a scar on her thigh as it is fairly large.  She was extremely irritable, awakening during the night many time screaming and crying for an hour or more at a time, for about 5 nights. Today is day 8, and she has now spiked a 104 temp again, but as the rash has faded, I am unsure if she has a secondary infection or if she is simply coming down with some other viral illness. Her twin brother had a similar course of illness with immunization on the same day with a slighly less severe rash.
Age: 53.0
Sex: M
Vaccine: TTOX
Symptoms: Arthralgia, Chest pain, Oedema peripheral
Clinical narrative: Elbow Pain, Left Arm Swell, Chest Pain. Given antibiotics to help neutralize vaccine reaction.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood alkaline phosphatase abnormal, Blood test normal, Immunology test normal, Madarosis, Thyroid function test normal
Clinical narrative: Noticed that eyelashes were totally gone and at eye exam February 23, 2012 asked doctor about what she thought may have caused it. Told it could be possibly allergy related or that rubbing the eyes could make them fall out.  Went to doctor in March 2012 about eyelashes and the fact that one eyebrow had started to fall out as well.  Took her for bloodwork to check for thyroid issues which was negative and we were told that if it got worse to call.  By the end of the week the eyebrow was totally gone and the other eyebrow had started to fall out.  Called Dr. back and was immediately referred to Dermatologist.  Saw dermatologist in April 2012 and he also ordered more bloodwork to screen for vitamin deficiencies or any auto-immune disorders/diseases.  Also started her on Protopic topical gel twice daily as an attempt to stimulate hair growth.  Went back to Dr. for a check up in June 2012 and both eyebrows were gone at this point.  Bloodwork was normal, only abnormality was her akaline phosphatase which the pediatrician said was from her growing and not to worry about it.  At this appointment I asked dermatologist specifically if the Gardasil vaccine could have cause this reaction.  He stated that he didn't think so, however, he also stated that he is not a "medical maintenance" physician and only practices dermatology.  In our research to see if there have been any additional cases of hair loss related to Gardasil, we have found that there are others who have had the same experience that we are having and that their children are also misdiagnosed as having alopecia areata.  This began 3-4 months after the third Gardasil vaccine which is exactly what is being reported by others and in each case all of the children were healthy and had normal bloodwork during the course of this reaction.
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Inflammation, Muscle spasms, Pain in extremity, Paraesthesia
Clinical narrative: Within one day, pain developed throughout left arm, and increased in intensity.  Reported severe arm pain to health department nurse after one week (06/28/2012) and was told that reactions to TDAP vary widely. On 06/29/2012, went to urgent care center where doctor said my reaction was uncommon, was likely inflammation due to tensing the muscle during administration of vaccine, and prescribed 5-day steroid. Began steroid on 6/29/2012 and completed on 07/03/2012. Pain subdued but not relieved. Pain increased after steroid was completed. 07/04/2012 began having spasms in left elbow. 07/05, developed numbness and tingling in arm, mostly from elbow to fingertips. Have been taking acetaminophen and ibuprofen for pain management since onset, with minimal benefit.
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Drug administration error, Hypoaesthesia, Musculoskeletal pain, Nerve injury, Pain in extremity
Clinical narrative: Within one day, pain developed throughout left arm, and increased in intensity.  Reported severe arm pain to health department nurse after one week (06/28/2012) and was told that reactions to TDAP vary widely. On 06/29/2012, went to urgent care center where doctor said my reaction was uncommon, was likely inflammation due to tensing the muscle during administration of vaccine, and prescribed 5-day steroid. Began steroid on 6/29/2012 and completed on 07/03/2012. Pain subdued but not relieved. Pain increased after steroid was completed. 07/04/2012 began having spasms in left elbow. 07/05, developed numbness and tingling in arm, mostly from elbow to fingertips. Have been taking acetaminophen and ibuprofen for pain management since onset, with minimal benefit.
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia
Clinical narrative: Within one day, pain developed throughout left arm, and increased in intensity.  Reported severe arm pain to health department nurse after one week (06/28/2012) and was told that reactions to TDAP vary widely. On 06/29/2012, went to urgent care center where doctor said my reaction was uncommon, was likely inflammation due to tensing the muscle during administration of vaccine, and prescribed 5-day steroid. Began steroid on 6/29/2012 and completed on 07/03/2012. Pain subdued but not relieved. Pain increased after steroid was completed. 07/04/2012 began having spasms in left elbow. 07/05, developed numbness and tingling in arm, mostly from elbow to fingertips. Have been taking acetaminophen and ibuprofen for pain management since onset, with minimal benefit.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy muscle normal, Cardiac stress test abnormal, Diaphragm muscle weakness, Drooling, Dysphagia
Clinical narrative: Shortness of breath, severe by next day, was admitted to hospital on 10/5/2011. Muscle weakness began within a week and continued to progress until January, when at it's worse had trouble swallowing, difficulty speaking, drooling, arm and leg muscle weakness, difficulty walking. Symptoms began to improve by early February, now muscle weakness is almost completely gone but still have sob, but it has improved.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Electromyogram abnormal, Gait disturbance, Muscular weakness, Neurological examination normal
Clinical narrative: Shortness of breath, severe by next day, was admitted to hospital on 10/5/2011. Muscle weakness began within a week and continued to progress until January, when at it's worse had trouble swallowing, difficulty speaking, drooling, arm and leg muscle weakness, difficulty walking. Symptoms began to improve by early February, now muscle weakness is almost completely gone but still have sob, but it has improved.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Speech disorder
Clinical narrative: Shortness of breath, severe by next day, was admitted to hospital on 10/5/2011. Muscle weakness began within a week and continued to progress until January, when at it's worse had trouble swallowing, difficulty speaking, drooling, arm and leg muscle weakness, difficulty walking. Symptoms began to improve by early February, now muscle weakness is almost completely gone but still have sob, but it has improved.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Presyncope
Clinical narrative: VASOVAGAL- NAUSEA, FAINTNESS, SWEATING, PALENESS.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of right upper arm, treated with BACTRIM DS 800/160mg x 7 days.
Age: 0.58
Sex: F
Vaccine: DTPIHI, PPV, RV5
Symptoms: Atrial flutter, Hypotonia, Posture abnormal, Pulse pressure decreased, Pyrexia
Clinical narrative: App. one hour after receiving DTAP, HIB, Oral Rotavirus, Pneumoccocal vaxs, Patient developed fever 101, and vomited continuously, about 10 times in one hour, pulse weakened, carotid artery in neck fluttered, breathing erratic, head fell back, body limp and pt was nonresponsive. EMS called.
Age: 0.58
Sex: F
Vaccine: DTPIHI, PPV, RV5
Symptoms: Respiratory disorder, Unresponsive to stimuli, Vomiting
Clinical narrative: App. one hour after receiving DTAP, HIB, Oral Rotavirus, Pneumoccocal vaxs, Patient developed fever 101, and vomited continuously, about 10 times in one hour, pulse weakened, carotid artery in neck fluttered, breathing erratic, head fell back, body limp and pt was nonresponsive. EMS called.
Age: 26.0
Sex: F
Vaccine: HPVX
Symptoms: Blood thyroid stimulating hormone, Hypothyroidism
Clinical narrative: I was diagnosed with Hypothyroidism, I have NO family history of this disease. I had normal TSH in 2006, no later tests done, however after my 3rd vaccination, I started developing symptoms.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Papule
Clinical narrative: Member developed sparse papules and abdomen and grapefruit size induration at injection site. Member resting and taking Benadryl, seems to improve sxs.
Age: 0.43
Sex: F
Vaccine: DTAP, RVX
Symptoms: Fatigue, Pyrexia, Unresponsive to stimuli
Clinical narrative: Had a fever of 104. Was very tired and not responsive. Was taken to ER and given meds.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site discolouration, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: The site of the injection bacame red, swollen, hot and painful.  Motrin was taken and ice applied.  Pain continued throughout the night making sleep difficult.  The next morning the entire upper arm was red, hot and swollen and the pain spread into the shoulder and under the arm.  Several blisters (fluid filled) appeared on the site.  One half of a Benadryl was taken and physician was called.  Physician requested that I come in to the office so she could observe the area.  She compared both arms to compare swelling, felt both upper arms to confirm heat in the effected arm, toke my temperature.  No temperature, she reccommended continue ice and Motrin and if no change or symptoms worsen call the office on 07/05/2012 and she would give me a prescription for an antibiotic.  I tolerated the pain by icing and using Motrin, the swelling and symptoms disapated by 07/07/2012, the blisters burst and drained.  At this time 07/08/2012 the site is still discolored and the area that was blisted is peeling.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site vesicles, Injection site warmth, Insomnia
Clinical narrative: The site of the injection bacame red, swollen, hot and painful.  Motrin was taken and ice applied.  Pain continued throughout the night making sleep difficult.  The next morning the entire upper arm was red, hot and swollen and the pain spread into the shoulder and under the arm.  Several blisters (fluid filled) appeared on the site.  One half of a Benadryl was taken and physician was called.  Physician requested that I come in to the office so she could observe the area.  She compared both arms to compare swelling, felt both upper arms to confirm heat in the effected arm, toke my temperature.  No temperature, she reccommended continue ice and Motrin and if no change or symptoms worsen call the office on 07/05/2012 and she would give me a prescription for an antibiotic.  I tolerated the pain by icing and using Motrin, the swelling and symptoms disapated by 07/07/2012, the blisters burst and drained.  At this time 07/08/2012 the site is still discolored and the area that was blisted is peeling.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Injection site swelling, Pyrexia, Swelling
Clinical narrative: Slight fever and swelling at injection site w/in 3 days of vaccination. More swelling and spreading redness by 3/6/12.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt. had large area of (R) arm (deltoid) swelling and erythema. Hot and painful to the touch. Pt. went to urgent care given MEDROL Dose pack; KEFLEX 500 mg qid x 10 d.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal distension, Decreased activity, Decreased appetite, Hypersomnia, Intussusception
Clinical narrative: Initial report received on 07 September 2011 from another manufacturer, report #WAES 1108USA03448. The initial reporter to his manufacturer had been a health care professional. The VAERS ID# 427694. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 6 month old male patient with none medical history or preexisting illness (patient status reported as "well") was vaccinated with the third dose of ROTATEQ, oral, (lot # reported as 669830/0078AA) on 20 June 2011. Concomitant therapy, given on the same date included third dose of PENTACEL, (Lot C3842AA) and third dose of PREVNAR 13 (Lot 916005). It was reported that the patient developed frequent vomiting on 02 July 2011 followed with abdominal distension and lethargy. It was confirmed ileocolic intussusception and required surgical reduction on 05 July 2011. The following information was obtained through follow-up and/or provided by the government. On 28 July 2011 primary care professional records received for Office visits/treatments completed from 20 June 2011 to 04 July 2011. The patient returned on 03 July 2011 with complained of vomiting and decreased appetite. Exam within normal limits (WNL) except for shotty nodes. Discharged home. It was noted that parent made several calls to primary care physician (PCP) on 04 July 2011 with complained of fever, abdominal distension and decreased activity level with increased sleep. Voiding decreased. Patient was referred to an ER. At the time of the report, the patient's outcome was unknown. The original reporting source was not provided. This report was considered serious by the agency due to hospitalization. No further information is available." Documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Lethargy, Lymph node palpable, Pyrexia, Surgery, Urine output decreased
Clinical narrative: Initial report received on 07 September 2011 from another manufacturer, report #WAES 1108USA03448. The initial reporter to his manufacturer had been a health care professional. The VAERS ID# 427694. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 6 month old male patient with none medical history or preexisting illness (patient status reported as "well") was vaccinated with the third dose of ROTATEQ, oral, (lot # reported as 669830/0078AA) on 20 June 2011. Concomitant therapy, given on the same date included third dose of PENTACEL, (Lot C3842AA) and third dose of PREVNAR 13 (Lot 916005). It was reported that the patient developed frequent vomiting on 02 July 2011 followed with abdominal distension and lethargy. It was confirmed ileocolic intussusception and required surgical reduction on 05 July 2011. The following information was obtained through follow-up and/or provided by the government. On 28 July 2011 primary care professional records received for Office visits/treatments completed from 20 June 2011 to 04 July 2011. The patient returned on 03 July 2011 with complained of vomiting and decreased appetite. Exam within normal limits (WNL) except for shotty nodes. Discharged home. It was noted that parent made several calls to primary care physician (PCP) on 04 July 2011 with complained of fever, abdominal distension and decreased activity level with increased sleep. Voiding decreased. Patient was referred to an ER. At the time of the report, the patient's outcome was unknown. The original reporting source was not provided. This report was considered serious by the agency due to hospitalization. No further information is available." Documents held by sender: None.