chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Oral herpes, Pallor
Clinical narrative: See other sheet. The next day after receiving my flu shot, I experienced hyperventilation and had to breath into a small brown paper bag. I also had a fever of 102-103 F with cold chills. I had nausea for 1 wk along with diarrhea. I had severe aching and pain in my muscles and stiffness in my joints. I had severe back pain esp in flank areas. I was told to call the doctor until the 3rd day after receiving the flu shot. I experiencing severe dizziness - my equilibrium was off and my gait was very unsteady - so much that I fell down 2 times I was pale, lethargic & depressed. I felt confused & disoriented. I developed severe sinus infections and fever blisters all over my upper & lower lips. My neck was very stiff and I had severe headaches, when I was finally able to go to the doctor, I was put on antibiotics, acyclovir and PHENERGAN. My flu test was negative. I was more sick than if I had the flu itself. I had no URI or congestion. I was told that I had a rare and severe reaction to the flu vaccine. I will never get another one. This was as sick as I have ever been. Thank you for the vaccine adverse effect form. It has been 1 wk now after receiving the vaccine, and I still don't feel well.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Sinusitis
Clinical narrative: See other sheet. The next day after receiving my flu shot, I experienced hyperventilation and had to breath into a small brown paper bag. I also had a fever of 102-103 F with cold chills. I had nausea for 1 wk along with diarrhea. I had severe aching and pain in my muscles and stiffness in my joints. I had severe back pain esp in flank areas. I was told to call the doctor until the 3rd day after receiving the flu shot. I experiencing severe dizziness - my equilibrium was off and my gait was very unsteady - so much that I fell down 2 times I was pale, lethargic & depressed. I felt confused & disoriented. I developed severe sinus infections and fever blisters all over my upper & lower lips. My neck was very stiff and I had severe headaches, when I was finally able to go to the doctor, I was put on antibiotics, acyclovir and PHENERGAN. My flu test was negative. I was more sick than if I had the flu itself. I had no URI or congestion. I was told that I had a rare and severe reaction to the flu vaccine. I will never get another one. This was as sick as I have ever been. Thank you for the vaccine adverse effect form. It has been 1 wk now after receiving the vaccine, and I still don't feel well.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Immediate post-injection reaction, Injection site pain, Oedema peripheral, Pain
Clinical narrative: Flu vaccine given - immediate soreness at delt inj site followed by pain in ipsilateral axilla and swelling. Swelling gone now constant sting/throb in axilla persist.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Feeling abnormal, Headache, Nausea, Pain
Clinical narrative: Headache, body aches, nausea, increased temp (100.4). Reports he felt awful.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 7 x 8 cm of erythema and edema surrounding injection site.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Crying, Dyspnoea, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Child received LAIV - dev. sneezing at monitoring station. Sneezing progressively got worse with mucus production. Started coughing. Offered water. C/o sore throat. 110/68 98.9. No difficulty swallowing. Notified parents. Coughing progressed. Appeared to have difficulty catching her breath during coughing episode. Called 911 EMT - not avail - fire unit to be sent. Coughing subsided & pt caught her breath. Declined fire rescue. 911 said if grandpa taking child nurse must go with them. Grandpa & child walked to car, RN followed with ER kit. In vehicle child noted to have change in breathing. Child crying asked if she was having difficulty EPIPEN Jr given. Administered in ER.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Sneezing
Clinical narrative: Child received LAIV - dev. sneezing at monitoring station. Sneezing progressively got worse with mucus production. Started coughing. Offered water. C/o sore throat. 110/68 98.9. No difficulty swallowing. Notified parents. Coughing progressed. Appeared to have difficulty catching her breath during coughing episode. Called 911 EMT - not avail - fire unit to be sent. Coughing subsided & pt caught her breath. Declined fire rescue. 911 said if grandpa taking child nurse must go with them. Grandpa & child walked to car, RN followed with ER kit. In vehicle child noted to have change in breathing. Child crying asked if she was having difficulty EPIPEN Jr given. Administered in ER.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: C/O soreness at injection site since date of injection. Denies numbness and tingling in left hand has tried heat, ice, TYLENOL & ADVIL. To follow up with PCP.
Age: 65.0
Sex: M
Vaccine: TD, TTOX
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Constant pain in left arm. The upper part, and constant pain in my left arm where shot was given. Also it hurts to lift my arm.
Age: 65.0
Sex: M
Vaccine: TD, TTOX
Symptoms: Back pain, Injection site pain, Pain in extremity
Clinical narrative: Constant pain in left arm. The upper part, and constant pain in my left arm where shot was given. Also it hurts to lift my arm.
Age: 65.0
Sex: M
Vaccine: TD, TTOX
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: After shot had pain where shot was given for 17 days. Pains were sharp up and down arm, plus across back. Still having pain.
Age: 65.0
Sex: M
Vaccine: TD, TTOX
Symptoms: Back pain, Injection site pain, Pain in extremity
Clinical narrative: After shot had pain where shot was given for 17 days. Pains were sharp up and down arm, plus across back. Still having pain.
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Fainted after flu shot - was sitting in chair - nurse lowered him to floor B/P 110/60 P. 76 - spirits of Ammonia given - recovered - went back to work.
Age: 50.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Patient had cellulitis at injection site (L) arm. Treated with antibiotics.
Age: 83.0
Sex: F
Vaccine: HBPV
Symptoms: Bacterial infection, Cellulitis, Erythema, Feeling hot, Pain
Clinical narrative: Pain, hot, swollen, red, doctor visit cellulitis, bacterial infection, prednisone, cephalexin, ciprofloxin, Vicodin.
Age: 83.0
Sex: F
Vaccine: HBPV
Symptoms: Swelling
Clinical narrative: Pain, hot, swollen, red, doctor visit cellulitis, bacterial infection, prednisone, cephalexin, ciprofloxin, Vicodin.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Antinuclear antibody negative, Areflexia, CSF protein normal, Electromyogram abnormal, Guillain-Barre syndrome
Clinical narrative: Bilateral lower extremity weakness, numbness, tingling, absence of reflexes, MRI and EMG findings consistent with Chronic Inflammatory Demyelinating Polyradiculopathy, treated with IVIG 1g/kg x2, then 10mg of prednisone daily until neurologic followup appointment in 3-4 weeks.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: HIV test negative, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Bilateral lower extremity weakness, numbness, tingling, absence of reflexes, MRI and EMG findings consistent with Chronic Inflammatory Demyelinating Polyradiculopathy, treated with IVIG 1g/kg x2, then 10mg of prednisone daily until neurologic followup appointment in 3-4 weeks.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Paraesthesia, Radiculopathy, Rheumatoid factor negative
Clinical narrative: Bilateral lower extremity weakness, numbness, tingling, absence of reflexes, MRI and EMG findings consistent with Chronic Inflammatory Demyelinating Polyradiculopathy, treated with IVIG 1g/kg x2, then 10mg of prednisone daily until neurologic followup appointment in 3-4 weeks.
Age: 46.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV, TYP
Symptoms: Pruritus, Urticaria
Clinical narrative: The patient devloped hives on his neck, trunk and upper thighs with itching.  No other symptoms noted. The hives lasted 48 hrs.  He took Benadryl 25 mg q.4 hrs for symptoms and applied hydrocortisone 1% cream to hives.
Age: 32.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Induration, Injection site pain, Lymphadenopathy, Musculoskeletal pain, Neck pain
Clinical narrative: Patient recieved a flu shot (GSH AFLLA693AA exp. 6/12 administered IM on left shoulder) and a Tdap (SP C3899AA exp. 11/9/13 administered IM on left shoulder) on 10/19/11.  Shortly after recieving the injections patient felt considerable soreness in the shoulder.  On 10/20/11 awoke and discovered pain above they left clavicle near the base of the neck that increased when moving head especially to the right.  It felt also as though patient was stretching the skin when moving the neck.  Had a large bump at this location and also a hard nodule under the skin that was not movable.  This pain and swelling continued for about 5 days.  The pain decreased each day, but the swelling and nodule continued to be present.  It appeared as though patient had a swollen Virchow's lymph node.  Pain was also associated with the injection site for about a week.  It is November 1st and the swelling and the nodule (possibly swollen lymph node) are still present, though the nodule has reduced in hardness and size somewhat.
Age: 32.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Pain, Subcutaneous nodule
Clinical narrative: Patient recieved a flu shot (GSH AFLLA693AA exp. 6/12 administered IM on left shoulder) and a Tdap (SP C3899AA exp. 11/9/13 administered IM on left shoulder) on 10/19/11.  Shortly after recieving the injections patient felt considerable soreness in the shoulder.  On 10/20/11 awoke and discovered pain above they left clavicle near the base of the neck that increased when moving head especially to the right.  It felt also as though patient was stretching the skin when moving the neck.  Had a large bump at this location and also a hard nodule under the skin that was not movable.  This pain and swelling continued for about 5 days.  The pain decreased each day, but the swelling and nodule continued to be present.  It appeared as though patient had a swollen Virchow's lymph node.  Pain was also associated with the injection site for about a week.  It is November 1st and the swelling and the nodule (possibly swollen lymph node) are still present, though the nodule has reduced in hardness and size somewhat.
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Dyspnoea, Headache, Insomnia, Lacrimation increased, Nasal congestion
Clinical narrative: Runny nose, headache, swollen nasal passages, difficulty breathing, painful breathing, difficulty sleeping, watery eyes. Continuing through 11/1/2011, symptoms have not abated.
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Painful respiration, Rhinorrhoea
Clinical narrative: Runny nose, headache, swollen nasal passages, difficulty breathing, painful breathing, difficulty sleeping, watery eyes. Continuing through 11/1/2011, symptoms have not abated.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthma, Condition aggravated, Contraindication to vaccination, Dyspnoea, Nasal congestion
Clinical narrative: Started with a very runny nose. By Thursday evening he was having severe asthma! It was about 24hrs after that of constant treatment. We were using the nebulizer every 2-3 hrs to keep his breathing under control. Plus the albuterol inhaler in between that and I started his Flomax prescription Thursday as well. Never had a fever but struggled with his breathing through Sat morning. Sat through Monday he had some residual stuffiness and congestion but we were able to stop with the treatments. He only gets asthma when he is sick but never near how bad it was after the Flumist. It was horrible! I called the advice nurse during the night Thursday and she said all you could do was treat the symptoms after the flu vaccine. We almost took him to the ER but the advice nurse just told me to treat the symptoms so I didnt. When the doctor's office opened Friday I called and he said he shouldn't have gotten the Flumist with asthma. He admitted fault but everyone has told me to report the incident to you guys so I am.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Started with a very runny nose. By Thursday evening he was having severe asthma! It was about 24hrs after that of constant treatment. We were using the nebulizer every 2-3 hrs to keep his breathing under control. Plus the albuterol inhaler in between that and I started his Flomax prescription Thursday as well. Never had a fever but struggled with his breathing through Sat morning. Sat through Monday he had some residual stuffiness and congestion but we were able to stop with the treatments. He only gets asthma when he is sick but never near how bad it was after the Flumist. It was horrible! I called the advice nurse during the night Thursday and she said all you could do was treat the symptoms after the flu vaccine. We almost took him to the ER but the advice nurse just told me to treat the symptoms so I didnt. When the doctor's office opened Friday I called and he said he shouldn't have gotten the Flumist with asthma. He admitted fault but everyone has told me to report the incident to you guys so I am.
Age: 51.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Local reaction, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Local reaction at vaccine site increase in redness, swelling, warmth and tenderness at site. Pt is afebrile. Red area marked with pen.
Age: 48.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Back pain, Chills, Erythema, Pain in extremity, Pyrexia
Clinical narrative: Immuns. x 2 on 10/19/11. Pt. called on 10/20/11 fever 101.0 --> 102.0, chills, back & legs hurt. Pt. took TYLENOL. Seen for OV. on 10/20. Right arm with erythema anterior, superior shoulder. No vesicles.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, FLU3, IPV, MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt. received PENTACEL in addition to IPV & MMR & Flu vaccines. Unable to reach pt's fm language barrier.
Age: 0.62
Sex: M
Vaccine: FLUX, HEP
Symptoms: Pyrexia
Clinical narrative: Very high temperature got up to 104.5 gave TYLENOL & ibuprofen every 4 hrs dropped to 101.5 then went back up to 103.5 in the early morning hours.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Musculoskeletal pain
Clinical narrative: Patient can rub area of arm and can feel nothing (numb) but if she lifts her arm there is a sharp pain in her shoulder. Pain ceases after arm is put back down.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Twenty five (25) minutes after flu vaccine was given colleague developed a rash on upper chest and neck. Given BENADRYL at that time, rash was worse on day #2 and sent to physician the next day for treatment.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Pyrexia, Vomiting
Clinical narrative: Several hours after vaccination, vomiting, diarrhea, headache, low grade fever.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Patient received his first flu shot in his life on 11/16/2010, he received the 2nd dose on 12/5/2010. During this time he was healthy. He was hospitalized on 3/9/11 and diagnosed with Type I diabetes.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Blood culture negative, C-reactive protein normal, Full blood count normal, Hyperhidrosis, Laboratory test normal
Clinical narrative: 1 hour after shot (2) & ROTATEQ pale - diaphoretic - for minutes - at office - normal - then 2nd episode & hospitalized.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Pallor
Clinical narrative: 1 hour after shot (2) & ROTATEQ pale - diaphoretic - for minutes - at office - normal - then 2nd episode & hospitalized.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Reddened area, tender to touch, increase in warmth at vaccine site back of right arm to elbow. Area marked. No increase since initial vaccine.
Age: 1.01
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL, FLUX, HIBV, MMR, PPV, VARCEL
Symptoms: Asthenia, Brain herniation, Brain oedema, CSF test, Diarrhoea
Clinical narrative: Patient with likely osteodysplastic primary dwarfism began to have vomiting, diarrhea, rash, fever on 10/20, became progressively weaker. Seen in urgent care clinic 10/23, became very weak after home on BENADRYL, came to ER. Found to have hydrocephalus (more than previous MRI), decorticate posturing, intubated, ventriculostomy perform, no longer responsive, cerebral edema and herniation.
Age: 1.01
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL, FLUX, HIBV, MMR, PPV, VARCEL
Symptoms: Endotracheal intubation, Hydrocephalus, Posturing, Pyrexia, Rash
Clinical narrative: Patient with likely osteodysplastic primary dwarfism began to have vomiting, diarrhea, rash, fever on 10/20, became progressively weaker. Seen in urgent care clinic 10/23, became very weak after home on BENADRYL, came to ER. Found to have hydrocephalus (more than previous MRI), decorticate posturing, intubated, ventriculostomy perform, no longer responsive, cerebral edema and herniation.
Age: 1.01
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL, FLUX, HIBV, MMR, PPV, VARCEL
Symptoms: Unresponsive to stimuli, Ventricular cisternostomy, Viral test, Vomiting
Clinical narrative: Patient with likely osteodysplastic primary dwarfism began to have vomiting, diarrhea, rash, fever on 10/20, became progressively weaker. Seen in urgent care clinic 10/23, became very weak after home on BENADRYL, came to ER. Found to have hydrocephalus (more than previous MRI), decorticate posturing, intubated, ventriculostomy perform, no longer responsive, cerebral edema and herniation.
Age: 1.01
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL, FLUX, HIBV, MMR, PPV, VARCEL
Symptoms: Brain oedema, Death, Decreased activity, Diarrhoea, Pyrexia
Clinical narrative: Patient with likely osteodysplastic primary dwarfism began to have vomiting, diarrhea, rash, fever on 10/20, became progressively weaker. Seen in urgent care clinic 10/23, became very weak after home on BENADRYL, came to ER. Found to have hydrocephalus (more than previous MRI), decorticate posturing, intubated, ventriculostomy perform, no longer responsive, cerebral edema and herniation.
Age: 1.01
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL, FLUX, HIBV, MMR, PPV, VARCEL
Symptoms: Rash, Vomiting
Clinical narrative: Patient with likely osteodysplastic primary dwarfism began to have vomiting, diarrhea, rash, fever on 10/20, became progressively weaker. Seen in urgent care clinic 10/23, became very weak after home on BENADRYL, came to ER. Found to have hydrocephalus (more than previous MRI), decorticate posturing, intubated, ventriculostomy perform, no longer responsive, cerebral edema and herniation.
Age: 1.01
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL, FLUX, HIBV, MMR, PPV, VARCEL
Symptoms: Asthenia, Brain herniation, Brain oedema, CSF test, Diarrhoea
Clinical narrative: Started with low grade, vomiting, diarrhea then developed diffuse rash/decreased activity. On 10/22 with +/- sz and then developed fulminant cerebral edema.
Age: 1.01
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL, FLUX, HIBV, MMR, PPV, VARCEL
Symptoms: Endotracheal intubation, Hydrocephalus, Posturing, Pyrexia, Rash
Clinical narrative: Started with low grade, vomiting, diarrhea then developed diffuse rash/decreased activity. On 10/22 with +/- sz and then developed fulminant cerebral edema.
Age: 1.01
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL, FLUX, HIBV, MMR, PPV, VARCEL
Symptoms: Unresponsive to stimuli, Ventricular cisternostomy, Viral test, Vomiting
Clinical narrative: Started with low grade, vomiting, diarrhea then developed diffuse rash/decreased activity. On 10/22 with +/- sz and then developed fulminant cerebral edema.
Age: 1.01
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL, FLUX, HIBV, MMR, PPV, VARCEL
Symptoms: Brain oedema, Death, Decreased activity, Diarrhoea, Pyrexia
Clinical narrative: Started with low grade, vomiting, diarrhea then developed diffuse rash/decreased activity. On 10/22 with +/- sz and then developed fulminant cerebral edema.
Age: 1.01
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL, FLUX, HIBV, MMR, PPV, VARCEL
Symptoms: Rash, Vomiting
Clinical narrative: Started with low grade, vomiting, diarrhea then developed diffuse rash/decreased activity. On 10/22 with +/- sz and then developed fulminant cerebral edema.
Age: 1.94
Sex: F
Vaccine: FLU3
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Patient received her first flu shot in her life on 11/13/2010 and her second dose on 12/14/10. Prior to receiving the flu vaccine she was healthy. Soon after 2/2011 she was hospitalized & diagnosed with Type I diabetes.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Diagnosed with cellulitis by Dr.
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Initial report was received from a health care professional on 20 October 2011. A female patient (date of birth and age were not reported) received an intramuscular injection of FLUZONE (site of administration not reported), lot number UH477AC on 29 September 2011. On 30 September 2011, the patient who is also a student went to the health center due to difficulty breathing after vaccination. The patient received corrective treatment with albuterol Inhaler, 2 puffs and the patient was fine. Medical history and concomitant medication were reported as unknown. The patient outcome was recovered/resolved. Documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Choking sensation, Cough, Increased upper airway secretion, Malaise, Pneumonia
Clinical narrative: Initial report was received from a health care professional on 15 September 2011. A 69 year-old female with no reported past medical history had received on 17 August 2011 at "2", an intramuscular left arm FLUZONE HIGH-DOSE No Preservative 2011-2012, lot number UH436AC. On 19 August 2011 in the AM, the patient experienced cough, general malaise for two weeks, nasal drip, excessive phlegm and a sensation of choking. The cough and malaise "cleared up" (date not reported). Adverse events following prior vaccination, illness at the time of vaccination and any other vaccines within four weeks prior to the suspect vaccine were all reported as "none". No further information was available at the time of the report. The patient was not recovered at the time of report. According to the reporter, outcome was unknown. Follow-up information was received from a healthcare professional on 26 October 2011. From new information received, it was determined this case now meet seriousness criteria, and it has been upgraded from non-serious to serious. The patient was seen by her primary care physician for follow-up and was diagnosed with pneumonia. The patient received corrective treatment with antibiotic (drug unknown) and is feeling fine. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Upper-airway cough syndrome
Clinical narrative: Initial report was received from a health care professional on 15 September 2011. A 69 year-old female with no reported past medical history had received on 17 August 2011 at "2", an intramuscular left arm FLUZONE HIGH-DOSE No Preservative 2011-2012, lot number UH436AC. On 19 August 2011 in the AM, the patient experienced cough, general malaise for two weeks, nasal drip, excessive phlegm and a sensation of choking. The cough and malaise "cleared up" (date not reported). Adverse events following prior vaccination, illness at the time of vaccination and any other vaccines within four weeks prior to the suspect vaccine were all reported as "none". No further information was available at the time of the report. The patient was not recovered at the time of report. According to the reporter, outcome was unknown. Follow-up information was received from a healthcare professional on 26 October 2011. From new information received, it was determined this case now meet seriousness criteria, and it has been upgraded from non-serious to serious. The patient was seen by her primary care physician for follow-up and was diagnosed with pneumonia. The patient received corrective treatment with antibiotic (drug unknown) and is feeling fine. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Flushing, Pruritus, Rash macular
Clinical narrative: Pruritus with scattered redness patches, non fluid filled on torso & arm. Face was flush with splotches.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site vesicles
Clinical narrative: Pt telephoned today said he has redness & soreness at injection site, he believes it is infected says he removed the bandaid two days ago and that he developed a blister. Says he has not seen a medical provider due to no funds. Referred to clinic.
Age: 72.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Myocardial infarction
Clinical narrative: Initial report received on 21 October 2011 from a Nurse Practitioner. A male patient (date of birth unknown) with unknown medical history had received a dose of FLUZONE HIGH-DOSE (lot number unknown) on an unknown date and 4 hours post-vaccination experienced an MI (myocardial infarction) requiring hospitalization. Patient's recovery status was reported as unknown. No further information was provided. Documents held by sender: None.
Age: 72.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Back pain, Chest pain, Nausea
Clinical narrative: Initial report received on 21 October 2011 from a Nurse Practitioner. A male patient (date of birth unknown) with unknown medical history had received a dose of FLUZONE HIGH-DOSE (lot number unknown) on an unknown date and 4 hours post-vaccination experienced an MI (myocardial infarction) requiring hospitalization. Patient's recovery status was reported as unknown. No further information was provided. Documents held by sender: None.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Influenza like illness, Musculoskeletal pain, Pain in extremity
Clinical narrative: Information has been received from a male patient with a history of chickenpox when he was 6 years old who on 04-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (therapy route not provided, lot # 669263/1361Z, expired date 15-JAN-2012) from his physician during a physical exam. "Within 5 days", on approximately 09-APR-2011 the patient developed lower back pain on the right side and by Thursday, 14-APR-2011 he developed a rash on his right foot, ankle and leg indicative of shingles. It was ultimately diagnosed as shingles. Atypically, it occurred in a motor function ganglion off the lumbar spine area. Patient believed that the vaccine might have awakened the virus thereby triggering the outbreak of shingles. At the time of reporting, the patient's outcome was unknown. The consumer questioned if perhaps there was an issue with the lot #. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question (669263/1361Z) were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information was received via medical records concerning a 60 year old male who on 04-APR-2011 was vaccinated with ZOSTAVAX (Merck). Concurrent medical conditions included asthma, hyperlipidemia, hypertension and gastroesophageal reflux disease. Past medical history included tonsillectomy, bone spur removal, ankle surgery, sinus surgery, thumb surgery and testicular torsion. On 14-APR-2011, the patient presented to his physician with a rash that was located primarily on the right lateral leg and right foot and was described as blistery, painful, red, warm and following a dermatome distribution. Associated symptoms included flu-like symptoms and pain in back, leg and buttocks, but not a fever. The physician noted that possible contributing factors might include recent illness, recent upper respiratory infection or he just got the ZOSTAVAX (Merck). Assessment was shingles. The patient was prescribed VALTREX. At the time of the report, the patient had recovered from shingles. Follow-up information was received from the responsible physician. On 04-APR-2011, at 3:00 pm, the 60 year old male received his first vaccination of ZOSTAVAX (Merck) in the left arm. He had no illnesses at the time of vaccination. On 14-APR-2011 (also reported as "within 5 days"), the patient had right low back pain and right leg pain with "a typical shingles rash". Patient was treated with VALTREX, prednisone and PERCOCET. He had severe pain for weeks, requiring multiple follow-up visits. The patient had not recovered as he still had some pain-post herpetic neuralgia at the time of the report. The physician reported that the shingles and post herpetic neuralgia resulted in persistent or significant disability/incapacity. All available medical records will be provided upon request. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Rash erythematous, Rash vesicular, Skin warm
Clinical narrative: Information has been received from a male patient with a history of chickenpox when he was 6 years old who on 04-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (therapy route not provided, lot # 669263/1361Z, expired date 15-JAN-2012) from his physician during a physical exam. "Within 5 days", on approximately 09-APR-2011 the patient developed lower back pain on the right side and by Thursday, 14-APR-2011 he developed a rash on his right foot, ankle and leg indicative of shingles. It was ultimately diagnosed as shingles. Atypically, it occurred in a motor function ganglion off the lumbar spine area. Patient believed that the vaccine might have awakened the virus thereby triggering the outbreak of shingles. At the time of reporting, the patient's outcome was unknown. The consumer questioned if perhaps there was an issue with the lot #. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question (669263/1361Z) were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information was received via medical records concerning a 60 year old male who on 04-APR-2011 was vaccinated with ZOSTAVAX (Merck). Concurrent medical conditions included asthma, hyperlipidemia, hypertension and gastroesophageal reflux disease. Past medical history included tonsillectomy, bone spur removal, ankle surgery, sinus surgery, thumb surgery and testicular torsion. On 14-APR-2011, the patient presented to his physician with a rash that was located primarily on the right lateral leg and right foot and was described as blistery, painful, red, warm and following a dermatome distribution. Associated symptoms included flu-like symptoms and pain in back, leg and buttocks, but not a fever. The physician noted that possible contributing factors might include recent illness, recent upper respiratory infection or he just got the ZOSTAVAX (Merck). Assessment was shingles. The patient was prescribed VALTREX. At the time of the report, the patient had recovered from shingles. Follow-up information was received from the responsible physician. On 04-APR-2011, at 3:00 pm, the 60 year old male received his first vaccination of ZOSTAVAX (Merck) in the left arm. He had no illnesses at the time of vaccination. On 14-APR-2011 (also reported as "within 5 days"), the patient had right low back pain and right leg pain with "a typical shingles rash". Patient was treated with VALTREX, prednisone and PERCOCET. He had severe pain for weeks, requiring multiple follow-up visits. The patient had not recovered as he still had some pain-post herpetic neuralgia at the time of the report. The physician reported that the shingles and post herpetic neuralgia resulted in persistent or significant disability/incapacity. All available medical records will be provided upon request. Additional information is not expected.
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Initial report was received from a health care professional on 21 October 2011. A female patient (date of birth and age were not reported) received an injection of FLUZONE (lot number, route, site and date of administration not reported). On 21 October 2011, the patient called the office to report that she developed the flu after receiving FLUZONE. The patient declined to provide further information. Medical history and concomitant medication were reported as unknown. No further information was available at the time of the report. The patient outcome was unknown. Documents held by sender: none.
Age: 1.48
Sex: F
Vaccine: DTAP
Symptoms: Bordetella test positive, Culture positive, Upper respiratory tract infection
Clinical narrative: Initial report was received 20 October 2011 from a consumer, who was also the patient's parent. A two-year-old female patient received a DTAP vaccine (manufacturer, lot number, route and site of administration were unknown) on 04 April 2011, and 161 days after vaccination, the patient had symptoms of an upper respiratory tract infection (URI) and was seen by her doctor on 12 September 2011. She had a nasal swab performed which came back positive for pertussis. An aspirate specimen was not performed. The reporter denied any clinical evidence of pertussis infection. Outcome was not reported and no additional information was provided at the time of the report. Documents held by sender: None.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Woke up middle of night about 12hr after getting vaccine with stiff painful neck. Stiffness diminished after 3 days ibuprofen OTC. At first did not relate it to vaccine but then she heard of someone else who experienced same thing so she decided to report it now. Is not currently having any problems.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Initial report was received on 18 and 25 October 2011 from a health care professional, who is also the patient's parent. A female patient (date of birth not reported) had received on 17 October 2011 a left arm injection of FLUZONE intradermal, lot number UT4163AA and five to ten minutes after injection, developed a red, painful knot that was approximately two inches. On 18 October 2011, the "knot was even larger approximately four to five inches and looks like cellulitis." According to the reporter, the patient's arm was red, swollen and painful from the site to almost the elbow. Treatments included ADVIL and ice to the area. No further information was available at the time of the report. The patient recovered on 25 October 2011. Documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pain
Clinical narrative: Initial report was received on 18 and 25 October 2011 from a health care professional, who is also the patient's parent. A female patient (date of birth not reported) had received on 17 October 2011 a left arm injection of FLUZONE intradermal, lot number UT4163AA and five to ten minutes after injection, developed a red, painful knot that was approximately two inches. On 18 October 2011, the "knot was even larger approximately four to five inches and looks like cellulitis." According to the reporter, the patient's arm was red, swollen and painful from the site to almost the elbow. Treatments included ADVIL and ice to the area. No further information was available at the time of the report. The patient recovered on 25 October 2011. Documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Speech disorder
Clinical narrative: Patient said she had difficulty swallowing and speaking. 20-30 minutes after vaccine. Called 911 and pt went to hospital and was there for several hours. Husband of pt did say she has panic attacks.
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Auricular swelling, Injection site pain, Injection site swelling, Rash
Clinical narrative: Swelling & pain at injection site. Swelling of pinna. joint pain, rash. Treated with antihistamine.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hot flush, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: 30-40 minuetes after injection developed numbness and tingling of face and lips, tightness in the throat, warm/hot flashes and a fine red rash on the face. Later in the am developed a headache.  Employee took Benadryl 25mg when s/s developed and the symptoms began to subside about 45 minutes later.  Continued to have a generalized itchiness for the remainder of the day and took an a antihistamine after work. The next day had no further s/s of a reaction.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Pruritus generalised, Rash erythematous, Throat tightness
Clinical narrative: 30-40 minuetes after injection developed numbness and tingling of face and lips, tightness in the throat, warm/hot flashes and a fine red rash on the face. Later in the am developed a headache.  Employee took Benadryl 25mg when s/s developed and the symptoms began to subside about 45 minutes later.  Continued to have a generalized itchiness for the remainder of the day and took an a antihistamine after work. The next day had no further s/s of a reaction.
Age: 52.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: RIGHT ARM HOT TO TOUCH, REDNESS, BELOW DELTOID TO 2 INCHES BELOW ELBOW; C/O ITCH, HIVE, SOB; REQUESTED TO HAVE PCP EVALUATION, COUNSELED -  10/28/11 FOLLOW UP MEDICAL EVAL, REQUIRED STEROID INTERVENTION
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Stomach cramps, diarrhea. 8 - 10 episodes/day x 3 days.
Age: 0.51
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Irritability, Pyrexia, Restlessness, Sleep disorder
Clinical narrative: First dose of DTaP given on 10/26/11.  Extremely crabby (could not put him down), poor appetite, restlsess, poor sleeping patterns at night on 10/27 & 10/28.  On 10/28 he vomited once in the evening.  I called the after hours exchange number.  Fever set in on 10/29 and persisted on and off until the evening of 10/30 (Tylenol was given as necessary).  Back to self on 10/31.
Age: 0.51
Sex: M
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: First dose of DTaP given on 10/26/11.  Extremely crabby (could not put him down), poor appetite, restlsess, poor sleeping patterns at night on 10/27 & 10/28.  On 10/28 he vomited once in the evening.  I called the after hours exchange number.  Fever set in on 10/29 and persisted on and off until the evening of 10/30 (Tylenol was given as necessary).  Back to self on 10/31.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: CLIENT REC'D FLU SHOT INJECTION LEFT DELTOID ON 10/18/2011. NOTICED REDNESS AND INFLAMMATION LEFT DELTOID AND UPPER LEFT ARM 10/19/2011. AREA IS WARM TO TOUCH, RED, AND BURNING SENSATION. SWELLING NOTED AT AREA OF INFLAMMATION. AREA AFFECTED IS APP 10 CM X 7 CM. NO SOB OR OTHER ANAPHYLACTIC REACTION NOTED.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pruritus generalised, Rash
Clinical narrative: Rash started on bilateral feet after receiving the vaccine for 1-2 hours with itching and burning throughout the body on 10/24/2011. Went to ER on 10/26/2011 and received a "shot", prescribed diphenhydramine and prednisone.
Age: 33.0
Sex: M
Vaccine: FLUN3
Symptoms: Activities of daily living impaired, Aldolase increased, Blood creatine phosphokinase normal, Blood lactate dehydrogenase increased, Full blood count normal
Clinical narrative: CC- atypical myositis following FluMist. 33 year old previously healthy man presented with a 3 day history of bilateral forearm pain and progressive hand and wrist weakness. He received FluMist (MedImmune on 10/11/11. Lot #501111P, Exp. 12/1/11) 10 days prior to the onset of symptoms and was well at that time. He had a concurrent viral URI without a fever at time of arm symptoms. No recent medications or exposures. He works in a hospital as a pediatric neurology resident. Symptoms began with soreness in bilateral proximal forearms which intensified over the following 2-3 days. These myalgias were exacerbated by use of the associated muscles. There was also soreness of the upper arms and legs, but this was considerably milder. Forearms also became progressively swollen and there was a faint reticular rash over the forearms and trunk. He developed progressive weakness of his bilateral intrinsic hand and wrist muscles, with flexors more affected than extensors. Right and left were equally involved. There was no weakness in any other muscle groups. Pain was severe enough to interrupt sleep and combined with the weakness inhibited regular activities of writing, typing, gripping utensils. Muscles of the forearm were tender to palpation, but not more proximally or in the lower limbs. The weakness and pain both peaked around day 3. Ibuprofen was mildly effective at treating the pain. There were no sensory changes and reflexes were preserved on exam. No lymphadenopathy or pharyngitis findings on exam.  No joint findings. Lungs clear. General PE otherwise normal. A Medrol dose pack was initiated for treatment of myositis. Symptoms gradually improved over the following 3-5 days with strength returning to normal and some persistent mild myalgias in the proximal forearms. Back to baseline on 10/31/11.
Age: 33.0
Sex: M
Vaccine: FLUN3
Symptoms: Metabolic function test, Muscular weakness, Myalgia, Myositis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: CC- atypical myositis following FluMist. 33 year old previously healthy man presented with a 3 day history of bilateral forearm pain and progressive hand and wrist weakness. He received FluMist (MedImmune on 10/11/11. Lot #501111P, Exp. 12/1/11) 10 days prior to the onset of symptoms and was well at that time. He had a concurrent viral URI without a fever at time of arm symptoms. No recent medications or exposures. He works in a hospital as a pediatric neurology resident. Symptoms began with soreness in bilateral proximal forearms which intensified over the following 2-3 days. These myalgias were exacerbated by use of the associated muscles. There was also soreness of the upper arms and legs, but this was considerably milder. Forearms also became progressively swollen and there was a faint reticular rash over the forearms and trunk. He developed progressive weakness of his bilateral intrinsic hand and wrist muscles, with flexors more affected than extensors. Right and left were equally involved. There was no weakness in any other muscle groups. Pain was severe enough to interrupt sleep and combined with the weakness inhibited regular activities of writing, typing, gripping utensils. Muscles of the forearm were tender to palpation, but not more proximally or in the lower limbs. The weakness and pain both peaked around day 3. Ibuprofen was mildly effective at treating the pain. There were no sensory changes and reflexes were preserved on exam. No lymphadenopathy or pharyngitis findings on exam.  No joint findings. Lungs clear. General PE otherwise normal. A Medrol dose pack was initiated for treatment of myositis. Symptoms gradually improved over the following 3-5 days with strength returning to normal and some persistent mild myalgias in the proximal forearms. Back to baseline on 10/31/11.
Age: 33.0
Sex: M
Vaccine: FLUN3
Symptoms: Oedema peripheral, Pain in extremity, Rash, Sleep disorder
Clinical narrative: CC- atypical myositis following FluMist. 33 year old previously healthy man presented with a 3 day history of bilateral forearm pain and progressive hand and wrist weakness. He received FluMist (MedImmune on 10/11/11. Lot #501111P, Exp. 12/1/11) 10 days prior to the onset of symptoms and was well at that time. He had a concurrent viral URI without a fever at time of arm symptoms. No recent medications or exposures. He works in a hospital as a pediatric neurology resident. Symptoms began with soreness in bilateral proximal forearms which intensified over the following 2-3 days. These myalgias were exacerbated by use of the associated muscles. There was also soreness of the upper arms and legs, but this was considerably milder. Forearms also became progressively swollen and there was a faint reticular rash over the forearms and trunk. He developed progressive weakness of his bilateral intrinsic hand and wrist muscles, with flexors more affected than extensors. Right and left were equally involved. There was no weakness in any other muscle groups. Pain was severe enough to interrupt sleep and combined with the weakness inhibited regular activities of writing, typing, gripping utensils. Muscles of the forearm were tender to palpation, but not more proximally or in the lower limbs. The weakness and pain both peaked around day 3. Ibuprofen was mildly effective at treating the pain. There were no sensory changes and reflexes were preserved on exam. No lymphadenopathy or pharyngitis findings on exam.  No joint findings. Lungs clear. General PE otherwise normal. A Medrol dose pack was initiated for treatment of myositis. Symptoms gradually improved over the following 3-5 days with strength returning to normal and some persistent mild myalgias in the proximal forearms. Back to baseline on 10/31/11.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain
Clinical narrative: Sore back, mild lower back pain.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Acanthosis, Biopsy skin abnormal, Full blood count normal, Hyperkeratosis, Inflammation
Clinical narrative: Initial report retrieved on 19 October 2011 via a search of the scientific literature. Lichen planus (LP) is an inflammatory dermatosis of unknown etiology that is primarily associated with liver disease. Recently, there have been several reports of LP developing after administration of the hepatitis B, influenza and MMR-DTAP-IPV vaccines. Here we report the first case of LP developing on the lower extremities of an otherwise healthy adult male after administration of the Tdap vaccine. We present this case to draw awareness to this observation in light of recently updated Tdap vaccination recommendations. A previously healthy 34-year-old male presented with a pruritic skin eruption on his lower extremities of three weeks duration. Physical examination revealed multiple scattered violaceous polygonal plaques with fine scale on the anterior lower legs, without any associated lesions on the skin, nails, or oral mucosa. The clinical diagnosis of LP was suspected and shave biopsy was performed. Histopathology demonstrated epidermal acanthosis with a focal saw-tooth-like pattern, hypergranulosis, hyperkeratosis with parakeratosis, scattered dyskeratotic keratinocytes within the epidermis and a band-like lymphocyte-predominant inflammatory infiltrate with associated basal vacuolar alteration. Based on the clinical and histopathologic findings, a diagnosis of LP was made. Routine laboratory tests, including complete blood cell count and liver function tests, were normal. Further inquiry revealed that four weeks prior to the eruption, the patient had received a single dose of ADACEL (lot number not reported) in his deltoid muscle. The vaccine was administered in accordance with recent Center for Disease Control guidelines, advising family members of young infants to receive the vaccination in order to minimize the risk of pertussis contraction in infants. Given the patient's otherwise non-contributory past medical and medication history, a diagnosis of LP subsequent to Tdap vaccination was made. The patient was treated with clobetasol 0.05% ointment over an eight-week period, resulting in gradual resolution of the eruption. Documents held by sender: None.