chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: TD
Symptoms: Contusion, Erythema, Neck pain, Pain, Swelling
Clinical narrative: Instant reaction - swelling - went home with an ice bag on it - got a large lump underneath the swelling. Painful arm all way down to fingers - got ugly large black and blue - then it began to get red down to elbow. Give medicine at another doctor office on my third visit - Cephalexin 500mg. After looking at the red marks going down my arm said he did not like the looks of the arm. Put a circle around it with a black marker pen and said if the red moved out of those marks I should go to th Emergency Room at the hospital that night. He then came in the next day - Saturday to look at it and it had not gotten any bigger as I had gone directly to the pharmacist and started the prescription medicine immediately. It then started to improve very slowly but it took about ten days or so for the black and blue and red marks to go away. I still have a little lump at the injection point and I still have some residual pain in my arm when I go to my senior exercises. I do notice since this injection I am having pain across my shoulder and up the back of my neck a good deal of the time which I never ever had before. I had 4 office visit the first for blood pressure checkup and received vaccine the rest for checking my arm (Oct 13,17,21,22). I have had tetanus injections before alone and never had any type of reaction to them but I had the diphtheria injection in grade school and had a bad reaction but the doctor just laughed and said that was more than 60 years ago.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Feeling abnormal, Insomnia, Pallor, Syncope
Clinical narrative: Student faint 2 minutes after injection. States she felt weak and "fuzzy" skin pale. Next day after immunization couldn't sleep and felt like she hallucinated. Recovered fully by day 2 (48 hours) 11/11/05.
Age: 1.04
Sex: F
Vaccine: UNK
Symptoms: Blister, Rash, Skin ulcer
Clinical narrative: Rash after 24 hrs - discrete lesions like tiny blisters mostly lower abdomen/sides one/two on arms.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: PAIN AT SITE OF INJECTION IN THE SHOULDER WENT TO ER MD SAID MAY HAVE NICKED A NERVE AND IT WOULD PROBABLY BE SORE FOR A COUPLE OF WEEKS PATIENT SAID PAIN WAS IN THE ARM SHE GOT HER PNEUMONIA SHOT IN
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: 7cm x 8cm localized erythema and pruritic reaction starting approx 8 hours after vaccine administration. No respiratory complaint. Treated with Loratidine 10mg once a day and Diphenhydramine 25mg every pm until symptoms resolve.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: 11/25/05 Patient called and spoke with Branch Manager in re: to having a flu and pneumonia shot on 11/22 and is experiencing swelling in arm....(it was not documented which arm this was occuring in). Director has attempted several times to reach patient to get more information.....calls were not successful..phone not answered.
Age: 1.02
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash developed after MMR vaccine approx 56 hours after administration.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Apathy, Asthenia, Hypoaesthesia, Laboratory test abnormal, Paraesthesia
Clinical narrative: "Flu shot yesterday - right after flu shot my toes started tingling, then the tingling increased - numbness started today.  I can't move my right arm or leg due to numbness".  no trouble breathing, "having trouble urinating", onset of syptoms was about 5 minutes after the flu shot according to the patient. Medical records state asthenia, urinary incontinence; apathy. msv I tried to follow up with this pt today, the phone number on her records has been diconnected.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Urinary incontinence
Clinical narrative: "Flu shot yesterday - right after flu shot my toes started tingling, then the tingling increased - numbness started today.  I can't move my right arm or leg due to numbness".  no trouble breathing, "having trouble urinating", onset of syptoms was about 5 minutes after the flu shot according to the patient. Medical records state asthenia, urinary incontinence; apathy. msv I tried to follow up with this pt today, the phone number on her records has been diconnected.
Age: 28.0
Sex: M
Vaccine: MMR
Symptoms: Chills, Pain, Pyrexia, Rash, Viral infection
Clinical narrative: 11/13/05 - wife stated" - started with face on face & fever. 11/14/05 - seen in ER with rash to face, low grade fever, body aches & chills. Diagnosed with: viral syndrome with rash vs: reaction to MMR vaccine. Sent home on Benadryl & Zyrtec.  11/15/05 - followed up - afebrile at this time. Rash had spread to face, arms, chest & back.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Urticaria
Clinical narrative: Patient contacted me on 11/30/05 re:  the pneumonia shot she received on 11/28.  She stated her rt. arm was hurting and that there was a red welp. going under her arm pit.  I suggested that she elevate the arm: apply a ice pack and call me back and her family physician if not any better.  On 11/30/05 I attempted a follow-up call; there was no answer.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Apnoea, Cardiovascular disorder, Cough, Fall, Guillain-Barre syndrome
Clinical narrative: Patient developed nausea and vomiting earlier the day of 28 Nov 05.  ER visit on am of 29 Nov 05.  Patient given IV analgesics, antiemetics,a nd IV fluids; diagnosis of volume depletion and viral syndrome.  Patient discharged to home.  Lost consciousness at home and fell off bed.  Transported to ER and intubated by EMT.  Patient is currently an inpatient at hospital. Information from Medical records states cough,myocarditis, cardiovascular disease. Mechanical ventilation & ICU.  Tx w/IVIG.  Feeding tube.  Slow improvement & transferred to inpatient rehab. Discharge summary states Guillian-Barre syndrome, myocarditis, apnea, pneumonia.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoxia, Laboratory test abnormal, Loss of consciousness, Myocarditis, Nausea
Clinical narrative: Patient developed nausea and vomiting earlier the day of 28 Nov 05.  ER visit on am of 29 Nov 05.  Patient given IV analgesics, antiemetics,a nd IV fluids; diagnosis of volume depletion and viral syndrome.  Patient discharged to home.  Lost consciousness at home and fell off bed.  Transported to ER and intubated by EMT.  Patient is currently an inpatient at hospital. Information from Medical records states cough,myocarditis, cardiovascular disease. Mechanical ventilation & ICU.  Tx w/IVIG.  Feeding tube.  Slow improvement & transferred to inpatient rehab. Discharge summary states Guillian-Barre syndrome, myocarditis, apnea, pneumonia.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pneumonia, Viral infection, Vomiting
Clinical narrative: Patient developed nausea and vomiting earlier the day of 28 Nov 05.  ER visit on am of 29 Nov 05.  Patient given IV analgesics, antiemetics,a nd IV fluids; diagnosis of volume depletion and viral syndrome.  Patient discharged to home.  Lost consciousness at home and fell off bed.  Transported to ER and intubated by EMT.  Patient is currently an inpatient at hospital. Information from Medical records states cough,myocarditis, cardiovascular disease. Mechanical ventilation & ICU.  Tx w/IVIG.  Feeding tube.  Slow improvement & transferred to inpatient rehab. Discharge summary states Guillian-Barre syndrome, myocarditis, apnea, pneumonia.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Myalgia, Pyrexia
Clinical narrative: Complained of muscle aches and fever requiring a visit to the ER.  This episode lasted less than 24 hours.  All tests and cultures were negative.  The physician told him that he felt the event was due to an allergic reaction to the flu vaccine.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Discomfort, Face oedema, Flushing, Hypersensitivity
Clinical narrative: CHIEF COMPLAINT: Allergic reaction.  HISTORY OF PRESENT ILLNESS: This 50-year-old female was in her usual state of health until about 30 minutes after getting her flu shot today. She then started to have itching in her palms which she recognized as an allergic reaction, having had a similar response to a soap which she is allergic to in the past. She then began to get flushed and itchy all over and began to notice some fullness in her lips and tongue and a sense of presyncope and pending doom. She was quickly placed in one of our patient care rooms where an IV access was established and I saw her. She had a hard time providing me much history initially because she was so anxious and uncomfortable. She did not report having problems breathing. She did not feel as though her airway was closing off.  PLAN: Received 50 mg of IV Benadryl and 8 mg of IV Zofran. Over the next 15 to 20 minutes her symptoms dramatically improved and she was observed for another hour. She received 1 L of IV fluid during that time and was essentially asymptomatic at the time of discharge except for a little bit of residual swelling in her hands. The patient will take 50 mg of Benadryl at bedtime tonight. She will continue the Benadryl on a q.6h. basis for the next 24 to 48 hours unless her symptoms have resolved in the morning and she is feeling well. She was told that if she was feeling up to it she could return to work tomorrow.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pruritus, Tongue oedema
Clinical narrative: CHIEF COMPLAINT: Allergic reaction.  HISTORY OF PRESENT ILLNESS: This 50-year-old female was in her usual state of health until about 30 minutes after getting her flu shot today. She then started to have itching in her palms which she recognized as an allergic reaction, having had a similar response to a soap which she is allergic to in the past. She then began to get flushed and itchy all over and began to notice some fullness in her lips and tongue and a sense of presyncope and pending doom. She was quickly placed in one of our patient care rooms where an IV access was established and I saw her. She had a hard time providing me much history initially because she was so anxious and uncomfortable. She did not report having problems breathing. She did not feel as though her airway was closing off.  PLAN: Received 50 mg of IV Benadryl and 8 mg of IV Zofran. Over the next 15 to 20 minutes her symptoms dramatically improved and she was observed for another hour. She received 1 L of IV fluid during that time and was essentially asymptomatic at the time of discharge except for a little bit of residual swelling in her hands. The patient will take 50 mg of Benadryl at bedtime tonight. She will continue the Benadryl on a q.6h. basis for the next 24 to 48 hours unless her symptoms have resolved in the morning and she is feeling well. She was told that if she was feeling up to it she could return to work tomorrow.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Pain, Pyrexia
Clinical narrative: I received an anthrax vaccination, the 3rd in the series of 4.  The day after the vaccination the site was red and inflamed.  Inflammation spread and increased.  Within two days my left deltoid and muscles extending to my elbow were inflamed and hot to the touch.  I had a moderate fever and experienced severe pain and swelling in my left upper arm and shoulder.  Because I was traveling and did not have my medical record, I did not visit a medical facility for care.  The fever and symptoms lasted for about a week, after which they rapidly subsided.  When I returned to my home I reported the event to the medical clinic where I had received the anthrax vaccination and was told it was not an "adverse event" because I had not reported it while it was occurring.  Therefore they refused to document it and it remains "undocumented."  Because I'm a dentist, I think I understand an adverse physical reaction when it occurs.  This  was definitely an adverse reaction as I spent several days in bed with fever.  Previously to this vaccination, I had experienced milder reactions to the anthrax vaccine.  Since they were becoming progressively worse, I refused the final, fourth vaccination because I was afraid of the consequences and because I believed that military medicine had been encouraged to not report adverse reactions.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Swelling
Clinical narrative: I received an anthrax vaccination, the 3rd in the series of 4.  The day after the vaccination the site was red and inflamed.  Inflammation spread and increased.  Within two days my left deltoid and muscles extending to my elbow were inflamed and hot to the touch.  I had a moderate fever and experienced severe pain and swelling in my left upper arm and shoulder.  Because I was traveling and did not have my medical record, I did not visit a medical facility for care.  The fever and symptoms lasted for about a week, after which they rapidly subsided.  When I returned to my home I reported the event to the medical clinic where I had received the anthrax vaccination and was told it was not an "adverse event" because I had not reported it while it was occurring.  Therefore they refused to document it and it remains "undocumented."  Because I'm a dentist, I think I understand an adverse physical reaction when it occurs.  This  was definitely an adverse reaction as I spent several days in bed with fever.  Previously to this vaccination, I had experienced milder reactions to the anthrax vaccine.  Since they were becoming progressively worse, I refused the final, fourth vaccination because I was afraid of the consequences and because I believed that military medicine had been encouraged to not report adverse reactions.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient came back to our branch on 11/30 to notify us that 3 hours after she recieved her pneumo shot that she had swelling/redness/hurting in her right arm.  This was the arm she received the pneumo shot in on 11/29.  I told her to elevate the arm,apply ice and if not better on 12/1 tp ca;; me after she notifies her physician.  On 12/1 she went to her physician and he gave a prescription for an antibiotic.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Influenza like illness, Injection site reaction, Skin discolouration, Urticaria
Clinical narrative: Within 48 hrs red welts down to forearm. Flu like symptoms. 1 week later red circle size of a dime appeared at injection site. Each day size increase with red bumps-appeared as a burn size of a half dollar. Used Benadryl tablets and cream/Claritin during day. After 6 weeks the area is still discolored and red bumps are still appearing.  12/01/05 Still have new red bumps appearing at site of injections.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Throat tightness
Clinical narrative: C/O itching, burning and tightness of throat 10 minutes after flu shot. Given antihistamine, observed for 30 minutes with vital signs monitored- sent to MD.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Lethargy, Nausea
Clinical narrative: Daughter states : My mother became nauseous after receiving the flu shot. She was also lethargic and her face appeared reddened around the cheeks. She felt like that until about 7 pm. She refused to go to an emergency room. Her MD was not available . She felt better after 7 pm.
Age: 35.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Flushing, Headache, Hyperhidrosis
Clinical narrative: Full body ached could hardly move, had a pounding headache for several days, skin hurt to the touch. Right arm was red and sore for several days, had chills and cold sweats. Body was flush.
Age: 35.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypokinesia, Myalgia, Pain, Tenderness
Clinical narrative: Full body ached could hardly move, had a pounding headache for several days, skin hurt to the touch. Right arm was red and sore for several days, had chills and cold sweats. Body was flush.
Age: 1.92
Sex: M
Vaccine: FLUX, PNC
Symptoms: Rash
Clinical narrative: Rash upper chest 24-48 hrs post vaccination.
Age: 1.36
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Local tissue induration and erythema at vaccine administration site.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Disorientation, Dyspnoea, Flushing, Headache
Clinical narrative: Flushed, shortness of breath, headache, disoriented.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot
Clinical narrative: Right shoulder and upper back became bright red and hot to touch 15 minutes after injection of influenza vaccine.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Client broke out into hives 10 minutes after receiving a flu shot.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac disorder, Musculoskeletal stiffness, Palpitations, Rash, Skin discolouration
Clinical narrative: Rash, purple spots developed day after injection noted stiffness of extremities and heart palpitation also.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Eye disorder, Pruritus, Sensation of pressure, Throat tightness
Clinical narrative: Five minutes after receiving flu shot client c/o throat tightness, pressure behind eyes, heavy chest and itching. Given antihistamine referred to MD.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Paraesthesia, Tongue disorder
Clinical narrative: Complained of tingling at arms and legs. Thick tongue, chills 25 minutes after flu shot, referred to MD.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: No ill effects due to injection.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Pyrexia, Sneezing, Vomiting
Clinical narrative: Child Took Vax on 11/22. On 11/24 woke up fever 100.5, a few hours later started vomiting quite often, sneezing, coughing. felt better next day.
Age: 1.13
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Child took varicella vas on 07/24/2001. In Dec 1st 2005 developed wide spread varicella.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Dr diagnosed chickenpox by clinical symptoms, onset 11/26/2005
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: parent reported lesions on entire body, diagnosed by physician on clinical symptoms 11/26/2005.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Mother called school nurse and reported a light case of chickenpox.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Father is a physician, mother called school nurse and reported child had a light case of chickenpox.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Dr confirmed 10/31/2005 lesions on entire body.
Age: 0.99
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Skin ulcer
Clinical narrative: Parent told school nurse child had fever 11/14/2005, lesions 11/15/2005 x 5 days. Brother also was parent diagnosed, not Dr confirmed.
Age: 1.27
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Skin ulcer
Clinical narrative: Reported by parent to school nurse child had lesions on trunk 11/12/2005. Not Dr confirmed. Lesions lasted for 4-5 days.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Fluid Filled lesions back, face, Trunk 10/28/2005, not Dr confirmed, mother called the nurse helpline of school 10/31, 11/01 and 11/02 2005.
Age: 1.26
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: parent reported to school nurse on 10/11/2005, child had vesicle like rash arms, legs bilaterally and trunk.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: Parent notified school nurse 11/18 and stated child had chickenpox, not Dr confirmed.
Age: 1.13
Sex: F
Vaccine: VARCEL
Symptoms: Fluid retention, Pyrexia, Skin ulcer
Clinical narrative: Fever 1-2 days prior to fluid filled lesions trunk and extremities 6 days. Sister broke out 10/17/2005. Neither case was Dr confirmed. Out of school 10/27, 10/25, 10/31 and 11/01/2005.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Parent called school nurse, child had fluid-filled lesions on trunk and extremities. Onset 10/17/05 times 5 days. Not confirmed by Dr.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Anorexia, Dysphagia, Fatigue, Musculoskeletal stiffness, Pain
Clinical narrative: Two days after receiving the flu shot I developed severe pain in my throat, difficulty in swallowing, a sharp pain accompanies each time I swallow, soreness, terrible scratchy feeling each time I swallow along with pain. A stiff neck, no temperature. Fatigue, loss of appetite. This is the 7th day since I received the shot.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngolaryngeal pain
Clinical narrative: Two days after receiving the flu shot I developed severe pain in my throat, difficulty in swallowing, a sharp pain accompanies each time I swallow, soreness, terrible scratchy feeling each time I swallow along with pain. A stiff neck, no temperature. Fatigue, loss of appetite. This is the 7th day since I received the shot.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Dry mouth, Myalgia
Clinical narrative: About 4 hrs. after receiving flu shot I started a constant cough which lasted about 4 hrs. Then I had chills on & off for about two hrs. No fever & aside from those 2 symptoms felt OK. Next day just muscle aches from coughing along with a very dry mouth and not quite feeling up to par energy wise though I did put it a full days work. The day after that felt  normal.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: PATIENT EXPERIENCED A RASH AT THE SITE OF INJECTION WHICH EXTENDED TO HER SHOULDER AND UPPER ARM. SHE ALSO EXPERIENCED SWELLING AND TIGHTNESS IN THE MUSCLE AT THE SITE OF INJECTION. THE RASH GRADUALLY DISAPPEARED IN APPROX. 7-10 DAYS. SHE STILL HAS A SLIGHT AMOUNT OF MUSCLE TIGHTNESS IN THE BACK OF THE BICEP WHEN SHE EXTENDS HER ARM. SHE TOOK TYLENOL AT THE ONSET OF REACTION BUT DID NOT TAKE ANY OTHER MEDS OR SEEK ANY TREATMENT FROM HER DOCTOR OR EMERGENCY CLINIC.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Face oedema, Fatigue, Injection site erythema, Pyrexia, Swelling
Clinical narrative: Pt evaluated in emergency department for fever 103, fatigue, swollen, red left arm, swollen face and lips. Received pneumovax 11/30/05, same day also received infuenza vaccine in the right arm (no problems noted in that arm).
Age: 39.0
Sex: M
Vaccine: FLUX, HEP, HEPA, TYP
Symptoms: Dermatitis acneiform, Myalgia, Pruritus
Clinical narrative: Mild febrile illness with myalgias at 4-5 days post-vaccination, but then with onset of diffuse, pruritic, acneiform (pustular) rash on post-vaccine day 11.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Injection site warmth, Oedema peripheral, Pain
Clinical narrative: R arm became severely painful,warm, red, edematous from upper arm down to hand.  Accompanied by fever.  Sx began few hours after flu vaccine administered and wosened with time.  Presentation consistent with cellulitis.  Required IV antibiotics twice in ER as well as course of PO antibiotics.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: R arm became severely painful,warm, red, edematous from upper arm down to hand.  Accompanied by fever.  Sx began few hours after flu vaccine administered and wosened with time.  Presentation consistent with cellulitis.  Required IV antibiotics twice in ER as well as course of PO antibiotics.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Pain
Clinical narrative: It has been a month since I had the vaccine and I still have pain in the shoulder where the shot was given.  I have trouble lifting my arm up higher than my shoulder and also have pain when I lift objects with that arm. I have taken Tylenol, Naproxen, and have used both heat and cold on the affected arm.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Pain in jaw, Shoulder pain
Clinical narrative: Severe pain in shoulder and back next day after shot was given on 11/01/05. Went to doctor on 11/07/05 and he prescribed a dose pack and muscle relaxant. Went back to doctor 11/14 or 15/05 prescribed pain meds.  Went to ER on 11/29/05 as pain had gotten worse, I felt this might be a heart attack.  Pain went from shoulder to neck and jaw area.  Discharged from ER after determining it was not heart related.  Pain is still in the left shoulder and surrounding area.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vertigo
Clinical narrative: Vertigo, began 24 hours after administration, slowly resolved after weeks.
Age: 50.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Medication error
Clinical narrative: FluMist nasal spray flu vaccine administered IM to deltoid.  Patient was a law enforcement responder detailed to hurricane relief duties at the time.  Nurse who administered vaccine was unaware of availability of nasal vaccine.  He broke off the tip of the syringe-like nasal spray devise and drew up .5 ml of the medication into a sterile syringe.  He then administered to the patient IM.  The error was discovered several hours later.  The patient was located and reported no adverse effects.  His vital signs, general health status, and the site of injection did not indicate any adverse reaction at any time over the following 5 days.  When contacted approximately 7 weeks after the event, there was still no indication of any adverse effects.  Although the patient reports no adverse effects from the mistake, it is being reported because the packaging of the product, using a syringe-like device to spray into nose, may be a contributing factor to the error and possibly could occur again.  The event was reported to the manufacturer immediately and apparently this was the first instance of IM injection of the FluMist.  I am a supervisor RN who was also deployed for hurricane relief.  I can be contacted to discuss the incident if need be.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Unevaluable event
Clinical narrative: Well appearing 2 month old infant given immunization at wellness visit. Apparently expired during sleep about 24 hours later.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Well appearing 2 month old infant given immunization at wellness visit. Apparently expired during sleep about 24 hours later.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Pruritus, Swelling, Urticaria
Clinical narrative: Generalized hives and whelps - Urticarial allergy reaction plus eyelid swelling, writs/ankle swelling, intense pruritus.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pharyngeal oedema, Tongue oedema
Clinical narrative: Less than 1 minute after administration  of Pneumovax pt's face turned bright read and complained of swelling tongue and throat. Pt given 2 dose of Epi pen 0.3mg. Pt was taken by EMS to emergency room for observation. She was discharged shortly later.
Age: 1.09
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Right arm red warm to touch at site of injection and surrounding area approx 2" diam. No fever.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site oedema, Joint range of motion decreased, Oedema
Clinical narrative: Information has been received from a LPN concerning an adult female with no known chronic medical conditions who on 21-NOV-2005 was vaccinated with Pneumovax 23 (lot #651330/1048P), 0.5 mL IM injection. On 22-NOV-2005, the pt called to complain that she could not raise her arm and she had redness and swelling at the site of the injection. Tylenol and ice to the are was ordered. Her husband called the physician on 23-NOV-2005 and stated the wife had elbow pain, redness, and swelling. The events were reported as not recovered. Follow-up information from the nurse on 28-NOV-2005 indicated that the pt had been instructed to call the physician's office if her symptoms worsened, As of 28-NOV-2005, the pt had not called the office back. The nurse considered the events could not raise her arm; redness and swelling at site of injection; and elbow pain, redness, and swelling to be other important medical events (OMIC). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a LPN concerning an adult female with no known chronic medical conditions who on 21-NOV-2005 was vaccinated with Pneumovax 23 (lot #651330/1048P), 0.5 mL IM injection. On 22-NOV-2005, the pt called to complain that she could not raise her arm and she had redness and swelling at the site of the injection. Tylenol and ice to the are was ordered. Her husband called the physician on 23-NOV-2005 and stated the wife had elbow pain, redness, and swelling. The events were reported as not recovered. Follow-up information from the nurse on 28-NOV-2005 indicated that the pt had been instructed to call the physician's office if her symptoms worsened, As of 28-NOV-2005, the pt had not called the office back. The nurse considered the events could not raise her arm; redness and swelling at site of injection; and elbow pain, redness, and swelling to be other important medical events (OMIC). Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: MMR
Symptoms: Chills, Pharyngolaryngeal pain, Pyrexia, Rash
Clinical narrative: Information has been received from a health professional concerning a 57 year old male employee with hypertension, gout, and no allergies, who on 16-SEP-2005 was vaccinated with a dose of MMR II. On 30-SEP-2005 the pt was admitted to the hospital with a fever, chills, a sore throat and a non-pruritic whole body rash. He was treated with BENADRYL. Subsequently, the pt recovered. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a registered nurse and physician concerning a 69 year old female patient with NKDA who on 9/27/05 was vaccinated in the right upper arm with a 0.5ml first dose of pneumococcal 23v polysaccharide vaccine (lot # 650454/0751P). Subsequently, in the evening of 9/27/05 the patient developed injection site localized erythema and swelling of the right upper extremity from the deltoid radiating down to the anterior bicep and to tricep region (13x13cm area). The patient's temperature was 100.1. The patient was seen in the physician's office on 9/28/05. The patient was treated with acetaminophen and ice pack applications. No product quality complaint was involved. The reporter considered the patient's adverse experiences to be other important medical events (OMIC). Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a physician concerning a 72 year old male with chronic obstructive pulmonary disease (COPD), a history of pneumonia (patient was hospitalized two weeks prior due to pneumonia) and no allergies who on 11/16/05 was vaccinated IM in the right arm with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 650082/0691P). Concomitant vaccination given on that same day included a dose of influenza virus vaccine. Concomitant therapy included fluticasone propionate, tiotropium bromide, zolpidem tartrate and fluticasone propionate, PRN. Within 24 hours of vaccination, on 11/17/05, the physician reported that the swelling was growing. Treatment with amoxicillin (+) clavulanate potassium and cold compresses was provided. The reporting physician stated that the patient may need to be hospitalized if the swelling did not improve. It was noted that prior to the vaccinations, the patient told the physician that he had not received the pneumococcal 23v polysaccharide vaccine, but post vaccination the patient stated that he may have been vaccinated with pneumococcal 23v polysaccharide vaccine recently. The reporting physician considered the adverse experience to be disabling and also considered it to be an other important medical event (OMIC). Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site pain, Sensation of heaviness, Swelling
Clinical narrative: Information has been received from a registered nurse concerning an 83 year old male with a history of prostate condition who on 10/19/05 was vaccinated SC with a second dose of 0.5ml pneumococcal 23v polysaccharide vaccine (lot # 650649/0790P). Concomitant therapy included an unspecified diuretic. On the evening of 10/19/05, the patient developed pain at the injection site. On 10/20/05 the patient's arm felt heavy, hot, red, and swollen. On 10/22/05 the patient continued to get worse so his family took him to the emergency room where he received IV antibiotics for 3 days and oral antibiotics for 7 days after that. The nurse reported that the patient was hospitalized but received the IV antibiotics as an outpatient. On 11/21/05 the patient reported to the nurse that he felt he had fully recovered. It was noted that the patient had received a first dose of pneumococcal 23v polysaccharide vaccine 20 years ago when he was in his 60s. No product quality complaint was involved. The nurse felt that pain at injection site and the arm felt heavy, hot, red and swollen were considered to be other important medical events because the patient told her that the ER physicians told him that if he had not come into the ER he might have lost his arm. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain, Swelling, Tenderness
Clinical narrative: Information has been received from a physician concerning a 73 year old white female with hypertension and hypothyroidism who on 10/18/05, at 11:00 AM, was vaccinated in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649694/0386P). On 10/18/05 at 1:00 PM, the patient developed right arm pain, right arm redness, right arm swelling, warmth and tenderness of right deltoid arm to right elbow. Subsequently, after 1 week, (10/25/05), the patient recovered. It was reported that the patient required medical intervention (not specified). The reporter considered the patient's experiences to be other important medical events (OMIC). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site oedema, Pain
Clinical narrative: Information has been received from a registered nurse via a company representative concerning a 62 year old female who in Oct 2005, was vaccinated IM in the right deltoid with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 649693/0456P). Concomitant therapy included a dose of influenza virus vaccine (unspecified) administered in the left arm. It was reported that within 15 minutes of being vaccinated, the patients arm began to hurt. She described the pain as feeling like a bee sting. She had a 2-3 inch circle of swelling and redness at the injection site. The spot was warm to the touch. Within 2 hours, the 2-3 inch circle spread all the way from her shoulder to her elbow. She went to the emergency room and they gave her a methylprednisolone (Medrol) dose pack and discharged her. Subsequently, on an unspecified date on Oct 2005, the patient made a full recovery. There was no product quality complaint involved. It was reported that the patients first vaccination with pneumococcal 23v polysaccharide vaccine was five years ago. The reporter considered the patients experiences to be other important medical events (OMIC). Additional information had been requested.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Hypokinesia, Pain, Swelling
Clinical narrative: Information has been received from a health professional concerning a 64 year old male who in October 2005, was vaccinated with a first 0.5ml IM dose in the right deltoid of pneumococcal 23v polysaccharide vaccine (lot # 649693/0456P). Concomitant therapy included atorvastatin calcium and concomitant vaccine administered on the same day included a dose in the left arm of influenza virus vaccine. In October 2005, about 3 hours after vaccination, the patient developed severe pain in his arm and he could barely move it. His arm was swollen and red. The patient went to the emergency room. He was given methylprednisolone and was discharged. It was reported that the patient made a full recovery. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. The event was considered to be an other important medical event by the reporter (OMIC). Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Depressed level of consciousness, Nasal oedema, Rash, Tongue oedema
Clinical narrative: Information has been received from a physician concerning a 5 year old male with a sulfa allergy who on Nov 16 2005 was vaccinated subcutaneously with a 0.5 ml dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot reported as 1012P). Concomitant vaccinations given on the same day at different sites included a dose of diphtheria toxoid + pertussis vaccine (unspecified) + tetanus toxoid and a dose of polio virus vaccine. Within 20 minutes of the vaccinations, on Nov 16 2005, the patient developed a diffuse rash over his entire body, decreased level of consciousness, mild swelling of tongue and mild swelling of nose. The child was treated in the ER with oral diphenhydramine hydrochloride (Benadryl), IV famotidine and IV methylprednisolone sodium succinate (Solumedrol). It was reported that the child recovered fully with in an hour and was released. No product quality complaint was involved. The reporting physician considered the patients adverse experiences to be other important medical events (OMIC) and he also considered them life threatening. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Loss of consciousness, Pruritus, Rash, Vomiting
Clinical narrative: Information has been received from a physician concerning a 5 year old male with a sulfa allergy who on Nov 16 2005 was vaccinated subcutaneously with a 0.5 ml dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot reported as 1012P). Concomitant vaccinations given on the same day at different sites included a dose of diphtheria toxoid + pertussis vaccine (unspecified) + tetanus toxoid and a dose of polio virus vaccine. Within 20 minutes of the vaccinations, on Nov 16 2005, the patient developed a diffuse rash over his entire body, decreased level of consciousness, mild swelling of tongue and mild swelling of nose. The child was treated in the ER with oral diphenhydramine hydrochloride (Benadryl), IV famotidine and IV methylprednisolone sodium succinate (Solumedrol). It was reported that the child recovered fully with in an hour and was released. No product quality complaint was involved. The reporting physician considered the patients adverse experiences to be other important medical events (OMIC) and he also considered them life threatening. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Hyperhidrosis, Migraine, Pruritus
Clinical narrative: A report was received from a healthcare professional on 17th November 2005, regarding a female vaccinee aged 32-40 years old. No details were provided regarding the vaccinee's medical history or concomitant medications. On 17th November 2005, the vaccinee received a Fluvirin vaccination intramuscularly,. Within 20 minutes the vaccinee experienced extreme flushing of the face, itching on her back, flushing, wooziness, shaking and sweating. The vaccinee did not go to hospital, but an observer said that she probably should have gone. The outcome of the vaccinee was unknown at the time of reporting. Follow up information received on 23rd November 2005 reported that the vaccinee returned to the site experiencing dizziness and feeling hot. Her blood pressure was checked at 12:30 pm the reading was 180/120, pulse 112-120. 911 was called. The vaccinee blood pressure was checked again and was 160/100, pulse 115. It was suggested that the vaccinee should go to her doctor. The vaccinee state that she felt like a migraine headache coming on. The vaccinee was not taken to hospital.
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: A report was received from a healthcare professional on 17th November 2005, regarding a female vaccinee aged 32-40 years old. No details were provided regarding the vaccinee's medical history or concomitant medications. On 17th November 2005, the vaccinee received a Fluvirin vaccination intramuscularly,. Within 20 minutes the vaccinee experienced extreme flushing of the face, itching on her back, flushing, wooziness, shaking and sweating. The vaccinee did not go to hospital, but an observer said that she probably should have gone. The outcome of the vaccinee was unknown at the time of reporting. Follow up information received on 23rd November 2005 reported that the vaccinee returned to the site experiencing dizziness and feeling hot. Her blood pressure was checked at 12:30 pm the reading was 180/120, pulse 112-120. 911 was called. The vaccinee blood pressure was checked again and was 160/100, pulse 115. It was suggested that the vaccinee should go to her doctor. The vaccinee state that she felt like a migraine headache coming on. The vaccinee was not taken to hospital.
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hot flush, Hypertension
Clinical narrative: A report was received from a healthcare professional on Nov 17 2005, regarding a female vaccine aged 32-40 years old. No details were provided regarding the vaccine's medical history or concomitant medications. On Nov 17 2005, the vaccinee received a Fluvirin vaccination intramuscularly. The vaccinee returned to the site to report she feels dizzy. She was hot and her blood pressure was high. Patient laid down and then felt better. Follow up received on Nov 23 2005 stating the vaccine returned to the vaccination site to report she feels dizzy. BP 140/82 pulse 72. The vaccine was asked if she would like to lie down. The vaccine said yes. The healthcare professional then followed her to the hall (close by and more private) and helped her to lie down. The vaccine then said that she felt better. She complained of feeling hot BP reached 200 140/78 pulse 74. The vaccine had no rash and difficulty breathing.
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Condition aggravated, Drooling, Dysarthria, Face oedema, Facial palsy
Clinical narrative: This is a serious spontaneous case involving Bells Palsy. The reporter causality is possible to FluMist. A 35 year old nurse with previous history of Bell's palsy secondary to head trauma when she was 8 years old, experienced slurred speech, watery eyes, drooling at night while asleep, inability to close right side of mouth completely and swelling of right side of face 2 days after receiving FluMist vaccine on Nov 12 2005. She was seen by her primary physician who referred her to a neurologist. She was diagnosed with Bell's Palsy. She was treated with oral prednisone for 6 days and Valtrex (Valacyclovir) for one week. No diagnostic procedures or laboratory test were done. By Nov 18 2005, her symptoms had improved and as of Nov 28 2005, she had completely recovered. However, she stated that she is beginning to have an ear infection. She will see her primary physician regarding treatment. No signs and symptoms of other central nervous system disorder was reported. The reported assessed the events as possibly related to FluMist.
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Lacrimation increased, Otitis media
Clinical narrative: This is a serious spontaneous case involving Bells Palsy. The reporter causality is possible to FluMist. A 35 year old nurse with previous history of Bell's palsy secondary to head trauma when she was 8 years old, experienced slurred speech, watery eyes, drooling at night while asleep, inability to close right side of mouth completely and swelling of right side of face 2 days after receiving FluMist vaccine on Nov 12 2005. She was seen by her primary physician who referred her to a neurologist. She was diagnosed with Bell's Palsy. She was treated with oral prednisone for 6 days and Valtrex (Valacyclovir) for one week. No diagnostic procedures or laboratory test were done. By Nov 18 2005, her symptoms had improved and as of Nov 28 2005, she had completely recovered. However, she stated that she is beginning to have an ear infection. She will see her primary physician regarding treatment. No signs and symptoms of other central nervous system disorder was reported. The reported assessed the events as possibly related to FluMist.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Agitation, Convulsion, Crying, Dyskinesia
Clinical narrative: 6 month old admitted for observation because of jerky movements noted by dad last night. His son had questionable reaction. He would cry with pertussis vaccine. Had seizure at 15 months with left sided paralysis. No seizure activity through the night. Adverse reaction to vaccine possible seizure. Will discharge, be slow on giving further vaccines.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pharyngeal oedema, Tongue oedema
Clinical narrative: Injection 4:30pm Nov 18, at 8:00pm throat started to swell with unbearable pain, tongue swelled and neck. ER, oxygen, Solu Medrol IV, Benadryl IV, Pepsin IV, Throat X ray, blood work.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: 24 hours after vaccine had edema / erythema / warmth of forearm deltoid.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Hypokinesia, Musculoskeletal stiffness, Pain
Clinical narrative: Left arm shoulder stiffed up, couldn't raise arm. Taken Advil and Tylenol. Condition slowly improving but today still in pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Positive erythema and swelling left deltoid.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chest pain, Chills, Cough, Dyspnoea
Clinical narrative: Severe chest pain, tightness of breath, wheezing, cough with phlegm. Chills and fever (up to 40 degrees C) pain at muscle site joints. Patient came to EOHS with a slip from urgent care. Patient state he did the flu shot at EOHS on Mon noon. A cough of his later restarted experiencing chest pain and sob. This was followed with hot/cold sweats into the evening after dinner. He called the triage nurse at emergency room. She advised him to go to the urgent care - he did this. A copy of the report is in file. "Vaccine Adverse Reporting System." He said the Dr on the slip said this was a reaction to the flu shot. Patient said however eh had a sore throat and cold for 2 wks prior to getting the flu shot. At Urgent Care he had blood test done which he indicated his white blood count was very high. He was put on an antibiotic and state he felt better after taking this. He had coughing with phlegm prior to the flu shot. Advised since he is on antibiotic he should follow-up with his PMD before the antibiotics is gone as if needs to cont. with antibiotic and be evaluated. 11/25/05 call patient -  completed medications but was unable to talk on cell phone will call me back to discuss current health state. 11/28/05 Symptoms 2 wk prior to when rec'd flu vaccine includes cough, mild sore throat, felt fine the day of vaccinations. Advised patient to consult PMD concerning future vaccines and allow them to administer if still recommended. 11/28/05 no symptoms. 11/29/05 Appt with Primary MD.