chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pelvic pain
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 15 or 16 year old female patient. On an unknown date the patient was vaccinated with GARDASIL dose 1. No concomitant medications were reported. On an unknown date the patient was vaccinated with dose 2 of GARDASIL. The nurse reported that the patient experienced pelvic pain  on an unknown date some time after receiving dose 2 of GARDASIL. The patient sought medical attention and visited the physician who treated the patient with unspecified medication for an unknown diagnosis. The outcome of pelvic pain is unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 14-OCT-2013 the patient was vaccinated with GARDASIL dose 1 for vaccination. No concomitant medications were reported. The nurse reported that the patient had come to office to receive the second dose of GARDASIL on 05-DEC-2013 but the dose was not administered at the time of all (reason unspecified). No adverse event was reported. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 78 year old female patient. The patient did not have any known allergies. On 04-DEC-2013 the patient was vaccinated with ZOSTAVAX lot # J003808, expiry date: 03-JUL-2014, in left deltoid for routine vaccination. On 05-DEC-2013, 2 days after onset of therapy the patient experienced redness, swelling, and tenderness at her injections site. The outcome of redness, swelling, and tenderness at her injections site today was reported as not recovered/not resolved. Causality was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Local vaccine reaction. Area of injection site red. Area measures 5x4cm indurated and 11x10cm total erythematous area on right arm. Pt thinks erythema has improved in the past day. Recommended cool compresses, OTC antihistamine and MOBIC (rx by physician). Will call if symptoms do not improve.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age with no pertinent medical history or drug reactions/allergies. On 02-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot # J006832, expiration date not reported, .065 ml, subcutaneous in the left arm) for vaccination and an unspecified flu short in the right arm. On 03-DEC-2013, the patient experienced lower back pain. The patient sought medical attention by calling pharmacist. There was no treatment given for the event. The outcome of lower back pain was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a para legal refers to a patient of unknown age and gender. The para legal stated in her conversation with MNSC representative that she had a client who, on an unknown date, was vaccinated with a dose of ROTATEQ (lot#, dose, frequency and route unspecified). On an unknown date the patient had a reaction to the ROTATEQ vaccine. The outcome of the event was unknown. The patient looked for the legal contact information in order to file a claim. Para legal was not prepared to participate in the report at this time. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient without pertinent medical history. On 06-OCT-2013 the patient was vaccinated with ZOSTAVAX lot # J004267, single dose, subcutaneous. A nurse practitioner mentioned to the reporter that her practice administers ZOSTAVAX in the deltoid muscle. No concomitant medications. Since administration of ZOSTAVAX the patient experienced pain and tenderness at the injections site. The patient visited an unspecified nurse practitioner who evaluated the event. The patient did not receive any treatment. The outcome of pain and tenderness at the injections site was reported as not recovered/not resolved. Reporter causality was not provided. Additional information has been requested
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist, via a field representative, refers to a early 70s years old female patient. Within the last three weeks (assumed in November 2013) the patient was vaccinated with ZOSTAVAX (dosing information and route were not provided). Immediately within minutes the injections site became swollen and itchy. The physician immediately gave the patient Benadryl and within 15 minutes the swelling dissipated and the patient was fully recovered. Reporter causality was not provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 5 year old male patient. On 19-JUN-2009. the patient was administered the first dose of VARIVAX (Merck) (Lot: 1409AA/ Expiration Date: 03-SEP-2013). On 19-JUN-2012, the patient was vaccinated with VARIVAX (Merck) dose 2 (Lot: 03784/ Expiration Date: Unspecified). Dose and route were unspecified. No concomitant medications were reported. On 13-NOV-2013, the patient experienced a rash described as less than 50 lesions, diagnosed as chickenpox, appeared at unspecified sites on patient's body. Patient sought medical attention at physician's office on 13-NOV-2013. The outcome of chicken pox was reported as resolved. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot #, dose and route not provided) one dose in the deltoid region of the arm. Other suspect therapies included, influenza virus vaccine (manufacturer unknown) coadministered (Lot number, dose and route not reported). On an unknown date, after receiving PNEUMOVAX 23 with influenza virus vaccine (manufacturer unknown) the patient developed swelling of the arm. On an unknown date, the patient went to the emergency room. At the time of the report, the swelling of the arm was unknown. This is one of two reports received from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient fainted for approximately 15 seconds. After the episode patient stated she almost always passes out when given needles. Patient observed after for approx. 20 minutes.
Age: 0.16
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 8 week old patient of unknown gender. On 28-JUL-2013 the patient was vaccinated with a first dose of RECOMBIVAX HB 10 mcg/ml (dose and route unknown). On 25-SEP-1997 the patient was vaccinated with a second dose of RECOMBIVAX HB 10 mcg/ml (dose and route unknown), as reported more than a month later after the first dose. On 09-DEC-1997 the patient was vaccinated with a third dose of RECOMBIVAX HB 10 mcg/ml (dose and route unknown), as reported less than 6 months after the first dose. No adverse effects were reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Injection site erythema, Injection site pruritus, Pain, Tenderness
Clinical narrative: This spontaneous report as received from a 59 year old female consumer reporting on herself with blood pressure and thyroid and no drug reactions or allergies who last Monday on 25-NOV-2013, was vaccinated in the left arm with a dose of ZOSTAVAX (route and lot number not reported). Concomitant therapies included Diovan, Synthroid and estrogens, conjugated, Prempro. The consumer reported that a noon for the next day on 26-NOV-2013, she developed reactions. She said that the vaccine injection site, which was on the left arm, itched and was red with soreness. Later in the same day following the injection, she noticed tenderness in the right side of her jaw along with shooting pain in her right eye. The consumer self-medicated with prescription Locoid cream. No lab diagnostics studies were performed. At the time of the report, the patient's outcome was unknown.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous report as received from a 59 year old female consumer reporting on herself with blood pressure and thyroid and no drug reactions or allergies who last Monday on 25-NOV-2013, was vaccinated in the left arm with a dose of ZOSTAVAX (route and lot number not reported). Concomitant therapies included Diovan, Synthroid and estrogens, conjugated, Prempro. The consumer reported that a noon for the next day on 26-NOV-2013, she developed reactions. She said that the vaccine injection site, which was on the left arm, itched and was red with soreness. Later in the same day following the injection, she noticed tenderness in the right side of her jaw along with shooting pain in her right eye. The consumer self-medicated with prescription Locoid cream. No lab diagnostics studies were performed. At the time of the report, the patient's outcome was unknown.
Age: 47.0
Sex: F
Vaccine: FLUR3
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Approximately 2 days post vaccine (given in (L) hip) the patient noticed a painful enlarged lymph node in her (L) groin 48 hrs later. Started KEFLEX 11/28 (500 QID) x 28 doses through 12/5. As of 12/6, lymph node is now normal size, non-tender, no further adenopathy.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with GARDASIL, stored for "many days" at 28 F (Fahrenheit), lot # H014645 expiry date not reported (dose and route not reported). Concomitant medication was not reported. No adverse effects reported. The reporter stated that 10 unidentified patients received unspecified frozen or refrigerated vaccine doses that were improperly stored. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with VARIVAX stored above 14 F for greater than 6 weeks, lot # reported as H018762 expiry date not reported (dose and route not reported). Concomitant medication was not reported. No adverse effects reported. The reporter stated than 10 unidentified patients received unspecified frozen or refrigerated vaccine doses that were improperly stored. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with VAQTA stored for many days' at 28F, lot # H010437 expiry date not reported and lot # H012669 expiry date 17-APR-2015 (dose and route not reported). Concomitant medication was not reported. No adverse effects reported. The reporter stated that 10 unidentified patients received unspecified frozen or refrigerated vaccine doses that were improperly stored. This is one of several reports from the same source. Additional information is not expected.
Age: 19.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Body temperature increased, Cold sweat, Headache, Influenza, Influenza A virus test positive
Clinical narrative: On 10/16/13 evening started not feeling well with headache and clammy. Progressed through evening. 10/17/13 temp 102 and headache. Upon arrival in office temp 104 and pulse ox 89. Transported to hosp. via ambulance. Influenza A positive. Admitted to ICU. Discharged 10/27/13 - symptoms consistent with influenza A. Seeing pulmonologist.
Age: 19.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Intensive care, Malaise
Clinical narrative: On 10/16/13 evening started not feeling well with headache and clammy. Progressed through evening. 10/17/13 temp 102 and headache. Upon arrival in office temp 104 and pulse ox 89. Transported to hosp. via ambulance. Influenza A positive. Admitted to ICU. Discharged 10/27/13 - symptoms consistent with influenza A. Seeing pulmonologist.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Affective disorder, Computerised tomogram head normal, Electrocardiogram ambulatory abnormal, Gait disturbance, Headache
Clinical narrative: 9/12/13 syncope within 5 minutes of receiving vaccine. 9/16/13 headache, weakness legs, mood issues went to ER, gait abnormality intermittent, urinary frequency. 10/14/13 tachycardia, hospitalized overnite. 11/23/13 improved leg weakness, cardiology consult tachycardia treated with CARDIZEM.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging brain normal, Pollakiuria, Syncope, Tachycardia
Clinical narrative: 9/12/13 syncope within 5 minutes of receiving vaccine. 9/16/13 headache, weakness legs, mood issues went to ER, gait abnormality intermittent, urinary frequency. 10/14/13 tachycardia, hospitalized overnite. 11/23/13 improved leg weakness, cardiology consult tachycardia treated with CARDIZEM.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood culture, Blood test, Bone densitometry, Cardiomyopathy, Catheterisation cardiac
Clinical narrative: Lower extremity weakness, respiratory failure, cardiomyopathy, possible Guillain Barre, pneumonia, EF = 30-35%. DVT's in legs, altered mental status.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Computerised tomogram head, Computerised tomogram thorax, Deep vein thrombosis, Electrocardiogram, Mental status changes
Clinical narrative: Lower extremity weakness, respiratory failure, cardiomyopathy, possible Guillain Barre, pneumonia, EF = 30-35%. DVT's in legs, altered mental status.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Pneumonia, Respiratory failure, Sputum culture
Clinical narrative: Lower extremity weakness, respiratory failure, cardiomyopathy, possible Guillain Barre, pneumonia, EF = 30-35%. DVT's in legs, altered mental status.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Headache, Nasal congestion, Ocular hyperaemia
Clinical narrative: 3 hours after her flu shot she started with tickle in throat and cough x 45 min hoarseness, headache -> intense -> like someone was kicking her in the head. Extreme nasal congestion and red eyes - achy.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Throat irritation
Clinical narrative: 3 hours after her flu shot she started with tickle in throat and cough x 45 min hoarseness, headache -> intense -> like someone was kicking her in the head. Extreme nasal congestion and red eyes - achy.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Condition aggravated, Cystic fibrosis, Dyspnoea, Laboratory test
Clinical narrative: Increase shortness of breath. Admitted into the hospital to receive IV antibiotics. Cystic Fibrosis - exacerbation.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Mycobacterium test, Sputum culture
Clinical narrative: Increase shortness of breath. Admitted into the hospital to receive IV antibiotics. Cystic Fibrosis - exacerbation.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Fatigue, Ocular hyperaemia, Pain
Clinical narrative: High fever, chills, body aches, extreme fatigue, fullness/tightness in chest, severe red eyes.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: High fever, chills, body aches, extreme fatigue, fullness/tightness in chest, severe red eyes.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Patient received ZOSTAVAX. Next day patient had reaction at injection site (redness, swelling) and went to urgent care. MD said she had cellulitis and prescribed Antibiotic, steroid, and pain medication.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with PROQUAD (Merck) stored above 14F (Fahrenheit) for greater than 6 weeks, lot # reproted as H021359 expiry date not reported (dose and route not reported). Concomitant medication was not reported. No adverse effects reported. The reporter stated that 10 unidentified patients received unspecified frozen or refrigerated vaccine doses that were improperly stored. This is one of several reports from the same source. Additional information is not expected.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersomnia, Local swelling, Pain in extremity
Clinical narrative: I gave the vaccine Saturday evening at 9 pm. The patient reported that she slept all day Sunday and that her arm hurt and was red and swollen.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Paraesthesia
Clinical narrative: (L) shoulder with sharp pains with movement, otherwise dull, lingering pain - continuous. (L) arm movement - tricep area pain radiates down arm - notable to lift arm over head, (L) fingertips tingle symptoms occurred day after vaccine.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (L.P.N.) refers to unknown number of patients of unknown gender, age and medical history. Approximately in 2013, the patients were vaccinated with PNEUMOVAX23 (lot# not reported) (dose, strength, route not reported) which had been exposed to temperature as low as 32 F on occasions in November 2013. No adverse effect was reported. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Sore upper arm where vaccine was given. Hasn't resolved over time. Pt would like to see MD to examine sore arm (left) since October 3rd.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: At site of injection warmth, swelling, redness and itchiness.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Pain in extremity
Clinical narrative: Sore arm, severe bursitis. Had to go to the Dr.
Age: 57.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever 101.9 with redness, swelling at injection site.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Pyrexia, Respiratory rate increased, Respiratory tract congestion
Clinical narrative: Pediatric flu shot given. Child was ill the next day, rapid breathing, congestion, fever. Diagnosed with flu by family Dr.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Chest discomfort, Chills, Cough, Headache
Clinical narrative: Chills, fever and malaise developed w/in hours of injections (11/19). Office visit 11/22 w/ headache, temp, red swollen area (R) upper arm - chest feeling tight and dry cough. One day later temp to 102.7 w/ increased chest symptoms. Given doxycycline, MEDROL dose pak and TESSALON PERLES - chest symptoms of tightness, cough continued - 2nd MEDROL dose pak given 12/2/13.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Chills, fever and malaise developed w/in hours of injections (11/19). Office visit 11/22 w/ headache, temp, red swollen area (R) upper arm - chest feeling tight and dry cough. One day later temp to 102.7 w/ increased chest symptoms. Given doxycycline, MEDROL dose pak and TESSALON PERLES - chest symptoms of tightness, cough continued - 2nd MEDROL dose pak given 12/2/13.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Poor quality sleep
Clinical narrative: After needle entered my arm the nurse leaned in and pushed and twisted needle in my arm. Pain level 10. After 4 weeks my pain level is a 10 with normal use. I've woken up every night since because my arm hurts, I fear permanent damage.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Blood test, Gait disturbance, Injected limb mobility decreased, Pyrexia
Clinical narrative: 3 hours after shot I could not raise my right arm. The night of taking shot, I run a high fever. The second day the pain moved into my back. The third and fourth days the pain was so bad that I couldn't walk without help. Then it started getting a little better every day. It took 2 weeks to get well.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Hypoaesthesia, Pain in extremity, Swelling, Tenderness
Clinical narrative: Some to no feeling, numbness more so, at the tip of the 2 end fingers on the left hand, fingers gets irritated when I touch things. Swells. Looks red at the tip of the fingers. The outside of looks red and hurts.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pt report arm soreness/stiffness in left arm still at 1 yr after vaccine. She has used MOTRIN off and on as treatment.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Joint swelling, Mobility decreased, Myalgia
Clinical narrative: Joint pain and swelling noted at RIGHT knee and RIGHT ankle, states had muscle pain above RIGHT knee and at RIGHT foot. States at approx. 3pm client could not lift her RIGHT leg independently, had to manually maneuver.  Pain and limitations lasted about 36 hours from first noting symptoms to complete alleviation.  Client did not vist MD, but did keep in touch with them via phone.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Nervousness
Clinical narrative: Severe headache, dizziness, nervousness also sore, red arm at injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Headache, Influenza like illness, Malaise
Clinical narrative: Headache, muscle & joint pain, general malaise - flu-like, nausea, diarrhea.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: Headache, muscle & joint pain, general malaise - flu-like, nausea, diarrhea.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Anxiety, Confusional state, Hypoaesthesia, Panic attack, Tremor
Clinical narrative: Serious confusion, in and out of reality, numbness in limbs, shaking.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient reports 8" X 6" hot red area with a 4" deep red mark in the middle.  Later she had Left, inner arm pain & left chest pain. Used ice & Benadryl. It is better today.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Full blood count, Headache, Hypoaesthesia, Injection site erythema
Clinical narrative: Patient woke up the morning after the vaccination with: 1) a 3" diameter warm, red area on his arm at the injection site that went away (with Benadryl) by nighttime *2)a "Numb" feeling in both legs. His legs felt wobbly and knees occasionally buckled. His legs were much weaker than normal but he did have strength to walk *3) over the next few days we realized that he couldn't handle any activities/sports that involved strenuous leg movements or impact (running/tae kwon do)...He would get intense leg pain that lasted the rest of the day- having to lay down. *4)He also developed constant (all day, every day)intense headaches a few days after the vaccination  5) These symptoms have not gone away but are lessened by a daily dose of 600 mg of Gabapentin
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site warmth, Muscular weakness, Neurological examination normal, Nuclear magnetic resonance imaging abdominal normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Patient woke up the morning after the vaccination with: 1) a 3" diameter warm, red area on his arm at the injection site that went away (with Benadryl) by nighttime *2)a "Numb" feeling in both legs. His legs felt wobbly and knees occasionally buckled. His legs were much weaker than normal but he did have strength to walk *3) over the next few days we realized that he couldn't handle any activities/sports that involved strenuous leg movements or impact (running/tae kwon do)...He would get intense leg pain that lasted the rest of the day- having to lay down. *4)He also developed constant (all day, every day)intense headaches a few days after the vaccination  5) These symptoms have not gone away but are lessened by a daily dose of 600 mg of Gabapentin
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Nuclear magnetic resonance imaging spinal normal, Pain in extremity
Clinical narrative: Patient woke up the morning after the vaccination with: 1) a 3" diameter warm, red area on his arm at the injection site that went away (with Benadryl) by nighttime *2)a "Numb" feeling in both legs. His legs felt wobbly and knees occasionally buckled. His legs were much weaker than normal but he did have strength to walk *3) over the next few days we realized that he couldn't handle any activities/sports that involved strenuous leg movements or impact (running/tae kwon do)...He would get intense leg pain that lasted the rest of the day- having to lay down. *4)He also developed constant (all day, every day)intense headaches a few days after the vaccination  5) These symptoms have not gone away but are lessened by a daily dose of 600 mg of Gabapentin
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: My arm has swollen at the injection site. It is red and hot and the rash is the size of the palm of my hand. This was the intradermal vaccine rather than the intramuscular. I have had the intramuscular for several years with no reaction.
Age: 65.0
Sex: F
Vaccine: FLUX, TD
Symptoms: Blindness unilateral, Headache
Clinical narrative: Major headache, loss of some vision in left eye headache last for three days vision has almost returned.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Headache, Pyrexia
Clinical narrative: Developed fever of 102 the afternoon after mist administered in school mass flu clinic on 10/17/13.  Fever resolved that night but mom reports c/o of H/A for next week.  Did not take to MD.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Body temperature increased, Headache
Clinical narrative: The afternoon Flu-Mist given in school clinic, child complained to mom of H/A when arrived home - temp done:  99.9/oral.  Given fever reducer and temp went down to normal.  The next day (10/18/13) at school, child reported to school nurse with H/A and temp of 101/oral.  Parent called - child went home; temp spiked to 103/oral.  Fever reducer given - did not go under 101/oral all weekend.  10/21/13, returned to school with temp back to normal.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Urticaria
Clinical narrative: 3 inch diameter welt with induration.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Endotracheal intubation, Guillain-Barre syndrome, Intensive care, Respiratory disorder
Clinical narrative: Guillain Barre diagnosed 11/25/13 - patient admitted to MICU and intubated for respiratory difficulties one week later (still in hospital - seems to be improving but no update yet today).
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre diagnosed 11/25/13 - patient admitted to MICU and intubated for respiratory difficulties one week later (still in hospital - seems to be improving but no update yet today).
Age: 39.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Asthenia, Muscle twitching, Seizure like phenomena
Clinical narrative: Client states he had seizure like symptoms.  He states he felt weak and layed down on the floor in his office at home.  He states he had some involuntary twitching.  He states that he woke up after falling asleep and went to bed.  He states that he slept well through the night and felt fine in the morning.  Employee did not seek medical care.  He was informed that he should be seen by his Provider.
Age: 1.04
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Blood culture negative, CSF culture negative, CSF test normal, Computerised tomogram head normal, Culture urine negative
Clinical narrative: Developed fever to 100.6.  Proceeded to have 5 generalized tonic clonic seizures each lasting approximately 10 minutes with 10 minutes of drowsiness in between each episode, not returning to baseline.  Presented to emergency room after 5th seizure where temperature was 103 and had additional generalized tonic clonic seizure lasting 40 seconds.
Age: 1.04
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Grand mal convulsion, Neutrophil percentage increased, Pyrexia, Somnolence, Viral test negative
Clinical narrative: Developed fever to 100.6.  Proceeded to have 5 generalized tonic clonic seizures each lasting approximately 10 minutes with 10 minutes of drowsiness in between each episode, not returning to baseline.  Presented to emergency room after 5th seizure where temperature was 103 and had additional generalized tonic clonic seizure lasting 40 seconds.
Age: 1.04
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: White blood cell count increased
Clinical narrative: Developed fever to 100.6.  Proceeded to have 5 generalized tonic clonic seizures each lasting approximately 10 minutes with 10 minutes of drowsiness in between each episode, not returning to baseline.  Presented to emergency room after 5th seizure where temperature was 103 and had additional generalized tonic clonic seizure lasting 40 seconds.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Neutropenia
Clinical narrative: This spontaneous report as received from a physician, as part of a marketing research program conducted by Market Research Agency, refers to a 63 year old male patient.  On an unknown date in 2013 the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (manufacturer unknown) (route, lot number and expiration date not reported). There was no concomitant medication reported. On approximately 01-NOV-2013 (beginning of November 2013) the patient had to be hospitalized because of neutropenia. The outcome of neutropenia was reported as recovered/resolved on 01-DEC-2013. The reporter considered neutropenia to be related to Pneumococcal Vaccine, Polyvalent (manufacturer unknown). Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report as received from a pharmacist refers to an over 65 year old male patient. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 (route, dose and lot number not provided). On an unknown date after vaccination with PNEUMOVAX23, the patient experienced community acquired pneumonia and was hospitalized. It was mentioned that the patient was on a cruise and was admitted to an unspecified hospital in another country for treatment. The patient's outcome was reported as recovered, on an unspecified date. Community acquired pneumonia was considered to be life threatening by the reporter. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives to left arm approximately 1 hr. after vaccine administration to left arm. BENADRYL 25 mg PO x 1 with resolution of symptoms.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Developed urticaria < 24 hours after vaccination.
Age: 0.61
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Diarrhoea, Vomiting projectile
Clinical narrative: Mother reports "severe/projectile vomiting" 30 min. after vaccines given. Pt. vomited 15 times and 1 diarrhea diaper. Afebrile.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Hand-foot-and-mouth disease, Pain, Purpura, Pyrexia, Skin exfoliation
Clinical narrative: Patient presented clinic on 11/29 with purpuric (deep) lesions on palms and soles with sloughing. He stated on 11/26, he developed fever to 103-105 degree F, prior to lesions developing. Also papular lesions buttocks and posterior legs. It was determined that patient had hand, foot disease he was treated with silverdene topically to feet and Antibiotics for Staph coverage. He was given medication for pain. He was told to stay off feet until lesions healed. Ace wraps/loose fitting shoes. Follow up with his PCP or clinic in 4-5 days.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Patient presented clinic on 11/29 with purpuric (deep) lesions on palms and soles with sloughing. He stated on 11/26, he developed fever to 103-105 degree F, prior to lesions developing. Also papular lesions buttocks and posterior legs. It was determined that patient had hand, foot disease he was treated with silverdene topically to feet and Antibiotics for Staph coverage. He was given medication for pain. He was told to stay off feet until lesions healed. Ace wraps/loose fitting shoes. Follow up with his PCP or clinic in 4-5 days.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Epistaxis, Headache, Pyrexia
Clinical narrative: Nose bleeds, headaches, low grade fever (tmax 100.1) s/p FLUMIST administration (3 days total).
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR
Symptoms: Immediate post-injection reaction, Injection site haematoma, Local swelling
Clinical narrative: I gave patient a KINRIX injection in right deltoid and immediately noticed hematoma develop approximately 2.54 cm in size. Supervisor was notified. Mother stated child had pediatrician appointment that afternoon. On 11/19/2013 at 9:04 a.m., I gave patient a KINRIX injection in the right deltoid and immediately noticed a hematoma approximately 2.65 cm developed. I immediately called the house supervisor and informed her of the observation. Supervisor took a picture of the child's arm. While speaking with the mom, she stated that the child had an afternoon appointment with his Pediatrician today. She was instructed to give TYLENOL and use ice pack as needed. On 11/20/2013 at approximate 8:35 a.m., I called mother to check on the status of patient. She stated his arm was still a little swollen, but Dr. said he should be fine. On 11/21/2013 a VAERS report was created and mailed. On 11/22/2013, a revised VAERS Report was submitted.
Age: 52.0
Sex: M
Vaccine: YF
Symptoms: Arthralgia, Blood bilirubin increased, Cerebellar syndrome, Chromaturia, Confusional state
Clinical narrative: Flu like illness 11/15/13 -> 11/20/13. Yellow fever headache 11/22/13 onset 11/26/13 fever, myalgia, dark urine, confusion arthralgia. Treated in ER with IV fluids. Found to have elevated transaminase, bilirubin, hypometria, thrombocytopenia (all new).
Age: 52.0
Sex: M
Vaccine: YF
Symptoms: Headache, Influenza like illness, Myalgia, Platelet count decreased, Thrombocytopenia
Clinical narrative: Flu like illness 11/15/13 -> 11/20/13. Yellow fever headache 11/22/13 onset 11/26/13 fever, myalgia, dark urine, confusion arthralgia. Treated in ER with IV fluids. Found to have elevated transaminase, bilirubin, hypometria, thrombocytopenia (all new).
Age: 52.0
Sex: M
Vaccine: YF
Symptoms: Transaminases increased, Yellow fever
Clinical narrative: Flu like illness 11/15/13 -> 11/20/13. Yellow fever headache 11/22/13 onset 11/26/13 fever, myalgia, dark urine, confusion arthralgia. Treated in ER with IV fluids. Found to have elevated transaminase, bilirubin, hypometria, thrombocytopenia (all new).
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Erythema, Local swelling, Pain
Clinical narrative: Fever 101.2, chills/rigors, severe body aches. (L) arm - entire upper arm red, hot, swollen, painful -> went on to cellulitis -> required KEFLEX 7 days P.O.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Fever 101.2, chills/rigors, severe body aches. (L) arm - entire upper arm red, hot, swollen, painful -> went on to cellulitis -> required KEFLEX 7 days P.O.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Pruritus
Clinical narrative: By 5 pm - 1513 - lips swollen - severe itching has been to ER x 2. Saw Dr - today received "shot" - steroids to take by mouth and has BENADRYL.
Age: 13.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Loss of consciousness, Posture abnormal
Clinical narrative: On 12/4/13 this client received Tdap, Hepatitis B, MMR, IVP vaccines at 2:20 PM. After the vaccines were administered, he stood up and walked over to his father on the other side of the clinic room, passed out and slumped into his father. He was lowered to the floor and his feet were elevated. He regained consciousness several moments later. BP was 90/50, pulse 64. No other symptoms. He then sat upright on the floor for several minutes. He reported he was not dizzy and stood up to sit in a chair. A 2:42 PM, the client was talking and reported that he felt fine and he denied any other symptoms. BP was 94/70. He left at 2:45 PM.
Age: 68.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Culture, Herpes zoster, Varicella, Varicella virus test
Clinical narrative: (L) arm varicella vs shingles (multiple patches of vesicles).
Sex: M
Vaccine: HEP
Symptoms: Brachial plexopathy
Clinical narrative: This case was reported by a physician (who is also the subject) and described the occurrence of brachial plexitis in a male subject aged between 40 and 49 years old who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date in approximately 1993 the subject received unspecified dose of ENGERIX B (unknown). At an unspecified time after vaccination with ENGERIX B, the subject experienced brachial plexitis. The subject reported that he received ENGERIX B about 20 years ago (approximately 1993) when it first came out, and that he experienced brachial plexitis after administration. The subject stated he reported it to the CDC. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the brachial plexitis was unspecified. The subject also reported experiencing events with AVODART, please see case A1051856A.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy concerning a female patient. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # H021717, expiration date 07-Mar-2014). On 29-Aug-2013, the patient experienced an adverse reaction (not further specified) to the ZOSTAVAX vaccine. Treatment and outcome of the adverse reactions were unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Local swelling, Skin warm
Clinical narrative: This spontaneous report has been received from a pharmacist via a sales representative concerning to a patient of unknown age and gender. Current conditions, medical history and drug reactions/allergies were not reported. In approximately November 2013 the patient was vaccinated with ZOSTAVAX injections, (dose, lot# and route not provided). Concomitant medication was not reported. On approximately 07-NOV-2013 (reported as one week ago), the patient experienced a baseball-sized swollen area on the arm that was warm to touch after patient received ZOSTAVAX. The outcome of the adverse events was unknown. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: FLUN4, HEPA
Symptoms: Pain, Swelling face, Urticaria
Clinical narrative: Swelling of the face and painful wheals on face and thighs.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: Patient describes red, inflamed, and induration at injection site a few days after Zostavax.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Redness, swelling and pain in (L) deltoid fever (lg) that started within 1 hr of receiving meningitis vaccine - see in-clinic 2 days later, symptoms persisting. Given BENADRYL 25 mg OTC.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: Flu shot was given Oct 2nd, 2013. Since the shot I was unable to lift my left arm above my waist. November 8, 2013 I was unable to move my left arm at all. I went to ER. The ER Dr. sent me to another hospital to an ortho who specializes in shoulders, who administered a steroid shot in my left shoulder. As of today Dec. 9th, 2013 I still do not have full use of my left arm.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling hot
Clinical narrative: 10 minutes after vaccine patient complained of dizziness and feeling warm. Pt was shopping store when this occurred. I advised her to be seated and checked her BP (140/82 Pulse: 65). Husband came to pick her up.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient (age unknown) which on 11-FEB-2013, the patient was vaccinated with GARDASIL (lot # not reported) dose 1. On 06-MAY-2013, the patient received the second dose of GARDASIL (lot # not reported) and the patient would like received the third dose. No adverse symptoms reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. Non drug reactions or allergies reported. On 23-NOV-2013, the patient was vaccinated with ZOSTAVAX (concentration, dose and route were not reported), lot # J006829, expiration date: 14-SEP-2014. Concomitant medication was not reported. On 28-NOV-2013, the patient noticed a red mark on her arm around the injection site, about 2 inches long and 1 inch wide that itched a little. Treatment was not given for the adverse events. Lab studies were not performed. The patient called the pharmacy to seek medical attention. The pharmacist noted that as of 02-DEC-2013, the patient had still the reactions. The patient's present status was reported as not recovered. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant referring about a patient of unknown gender and age. Concurrent conditions and medical history were not provided. Certified medical assistant reported that a patient received GARDASIL (dose, route, indication and lot number were not provided) on 25-JUL-2013, 16-OCT-2013 and 29-NOV-2013. No adverse effect reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Bumpy and red rash on upper arm where vaccine was given.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: 57 yo F with multiple medical issues including asthma, hyperthyroidism, rhinitis was given Pneumovax (lot #J005071 - Merck & Co., exp 1/19/15) 0.5ml SC and Tdap (lot # 4T7E4 - GSK; exp 3/18/16) 0.5ml IM in the right arm on 12/2/13. Following injection, pt states she had pain, swelling and itching at the site. Symptoms worsened over next two days until pt reported swollen, red and painful right arm to MD on 12/5. Pt mentioned erythema tracks from mid humerus to mid radius. Pt was seen again in clinic 12/5 and diagnosed with cellulitis. Reported fever, chill and malaise. Cefalexin 1000mg po BID prescribed x 10 days.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site swelling, Malaise, Pyrexia
Clinical narrative: 57 yo F with multiple medical issues including asthma, hyperthyroidism, rhinitis was given Pneumovax (lot #J005071 - Merck & Co., exp 1/19/15) 0.5ml SC and Tdap (lot # 4T7E4 - GSK; exp 3/18/16) 0.5ml IM in the right arm on 12/2/13. Following injection, pt states she had pain, swelling and itching at the site. Symptoms worsened over next two days until pt reported swollen, red and painful right arm to MD on 12/5. Pt mentioned erythema tracks from mid humerus to mid radius. Pt was seen again in clinic 12/5 and diagnosed with cellulitis. Reported fever, chill and malaise. Cefalexin 1000mg po BID prescribed x 10 days.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Anxiety, Asthenia, CSF test, Chills, Computerised tomogram
Clinical narrative: Started upon awakening with feet and hands feeling numb and tingly.  Also started with headache described as behind his eyes.  Seen in ED on 10/11/13 with parasthesias.  Stated numbness and tingling had progressed to his entire body. Sent home with diagnosis of paresthesias, anxiety.  10/13/2013 to ED with increasing numbness, tingling arms, legs accompanied by pain, chills.  Gradual onset weakness - reported as severe by patient.  Bilateral face affected, unable to swallow.  Patient hospitalized and required intensive care treatment.  On ventilator and ended up with tracheostomy.  Tube feedings and eventual PEG tube.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Dysphagia, Eye pain, Gastrointestinal tube insertion, Gastrostomy
Clinical narrative: Started upon awakening with feet and hands feeling numb and tingly.  Also started with headache described as behind his eyes.  Seen in ED on 10/11/13 with parasthesias.  Stated numbness and tingling had progressed to his entire body. Sent home with diagnosis of paresthesias, anxiety.  10/13/2013 to ED with increasing numbness, tingling arms, legs accompanied by pain, chills.  Gradual onset weakness - reported as severe by patient.  Bilateral face affected, unable to swallow.  Patient hospitalized and required intensive care treatment.  On ventilator and ended up with tracheostomy.  Tube feedings and eventual PEG tube.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Headache, Hypoaesthesia, Intensive care, Mechanical ventilation, Nuclear magnetic resonance imaging
Clinical narrative: Started upon awakening with feet and hands feeling numb and tingly.  Also started with headache described as behind his eyes.  Seen in ED on 10/11/13 with parasthesias.  Stated numbness and tingling had progressed to his entire body. Sent home with diagnosis of paresthesias, anxiety.  10/13/2013 to ED with increasing numbness, tingling arms, legs accompanied by pain, chills.  Gradual onset weakness - reported as severe by patient.  Bilateral face affected, unable to swallow.  Patient hospitalized and required intensive care treatment.  On ventilator and ended up with tracheostomy.  Tube feedings and eventual PEG tube.