chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: At injection site, swollen, red, and feverish. Patient went to the doctor and was diagnosed with cellulitis. Patient received antibiotic treatment and now better.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: At injection site, swollen, red, and feverish. Patient went to the doctor and was diagnosed with cellulitis. Patient received antibiotic treatment and now better.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Full blood count normal, Headache, Mononucleosis heterophile test negative, Nausea
Clinical narrative: 1/13/14 10:45 AM GARDASIL given. 1/14/14 7:30 AM c/o severe headaches, nausea, slight dizziness and "teeth hurt". All tests and physical exam normal. Continue MOTRIN, light diet and rest. Advised not to complete GARDASIL. Also fever 102 degrees by that afternoon - 1/14/14.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Streptococcus test negative, Toothache
Clinical narrative: 1/13/14 10:45 AM GARDASIL given. 1/14/14 7:30 AM c/o severe headaches, nausea, slight dizziness and "teeth hurt". All tests and physical exam normal. Continue MOTRIN, light diet and rest. Advised not to complete GARDASIL. Also fever 102 degrees by that afternoon - 1/14/14.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Defaecation urgency, Nausea, Vomiting
Clinical narrative: Nausea severe abdominal pain, throwing up, bathroom urgency.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Injection site pain, Injection site swelling, Nausea, Pain in extremity
Clinical narrative: Painful leg at injection site with slight swelling - nausea/vomiting, chest discomfort with racing heart, left arm pain symptoms started evening of injection day and subsided 36 hrs later.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Palpitations, Vomiting
Clinical narrative: Painful leg at injection site with slight swelling - nausea/vomiting, chest discomfort with racing heart, left arm pain symptoms started evening of injection day and subsided 36 hrs later.
Sex: M
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Patient received the flu vaccine on 1/4/14 72 hours later he developed Bells Palsy.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Vaccination site rash
Clinical narrative: Rash in vaccine area.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Inflammation, Tendon pain, Tendon rupture
Clinical narrative: Patient reports tendon soreness/inflammation/rupture on 1/3/14. Onset after receiving vaccine, immediately. Patient reports that doctor feels it was administered too high on the deltoid.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Tendon pain, Tendon rupture, Tendonitis
Clinical narrative: Patient reports tendon soreness/inflammation/rupture on 1/3/14. Onset after receiving vaccine, immediately. Patient reports that doctor feels it was administered too high on the deltoid.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Facial pain, Pain, Pruritus, Rash
Clinical narrative: Rash with blisters. Itching. Facial Pain. Pain. Treatment: Valtrex, Bactrim, Keflex, Neurontin.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site reaction, Injection site warmth, Muscle rupture
Clinical narrative: At injection site -> redness, bruising, warm to touch, muscle soreness -> pt said she tore bicep muscle approx. 3 months ago.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: At injection site -> redness, bruising, warm to touch, muscle soreness -> pt said she tore bicep muscle approx. 3 months ago.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Blood test, Chest X-ray, Injection site pain, Lymphadenopathy, Pyrexia
Clinical narrative: This spontaneous report was received from the patient's mother refers to his son a 2 year old male patient. Patient with no pertinent medical history, drug reactions or allergies. On 27-DEC-2013 (three weeks ago) the patient was vaccinated with MMR II (dose, route, lot number and expiration date no reported) in the upper left arm for route vaccination. There was no concomitant medication reported. It was reported that the patient initally had fever and soreness at the injection site, but on 15-JAN-2014, the patient had developed and was diagnosed with regional adenopathy. The patient sought for medical attention and was seen in office visit. Lab diagnostic studies performed: bloodwork, chest x-ray and Purified Protein Derivate (PPD) test (results not provided). The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Tuberculin test
Clinical narrative: This spontaneous report was received from the patient's mother refers to his son a 2 year old male patient. Patient with no pertinent medical history, drug reactions or allergies. On 27-DEC-2013 (three weeks ago) the patient was vaccinated with MMR II (dose, route, lot number and expiration date no reported) in the upper left arm for route vaccination. There was no concomitant medication reported. It was reported that the patient initally had fever and soreness at the injection site, but on 15-JAN-2014, the patient had developed and was diagnosed with regional adenopathy. The patient sought for medical attention and was seen in office visit. Lab diagnostic studies performed: bloodwork, chest x-ray and Purified Protein Derivate (PPD) test (results not provided). The outcome of the event was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 01-JUL-2013 at 07:40, ZOSTAVAX (lot # J001005 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 44.5 hours. On 26-JUL-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J001005, Exp. Date: 24-APR-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in jaw, Trigeminal neuralgia
Clinical narrative: Initial information received from a healthcare provider who is also the patient, on 13 January 2014. A 55 year old male patient had received his dose of FLUZONE (lot # UH900AC) on 06 January 2014, route and site of administration were not reported. On 09 January 2014, i.e. within 72 hours, the patient began to experience trigeminal neuralgia. The trigeminal neuralgia had lasted 4 days and was decreasing at the time of the report. The patient had no allergies and had a medical history of hypertension, hypercholesterolemia and kidney stones. The patient did not receive any other vaccinations within 4 weeks of FLUZONE administration. Laboratory tests and concomitant medications were not reported. The jaw pain was 98 percent better on 13 January 2014. The patient outcome was not recovered. Documents held by sender: None.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 20-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot # 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14.25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to an exact time not recorded, noted as equal to or >12C for an estimated total time out of range of 10.5 hours. On 08-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: DTAP, FLU3, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: MMR (R) thigh SQ J003785 3/28/15 Merck. Rash over body. Around eyes and body 10 days past vaccination. Seen in ER 01/18/14 FU at office 1/20/14. Normal MMR rash not MMR Ds.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood glucose decreased, Dyspnoea, Fatigue, Hypoglycaemia, Hypotension
Clinical narrative: The day after the vaccine administration (1/18/14) pt suffered very low blood pressure and sugar levels. Pt is diabetic and had to took off his insulin bomb. Pt was suffering from fatigue 1/22/14 and could not breathe. Pt was hospitalized and Dx with pneumonia and a big infection in blood.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Infection, Pneumonia, Sepsis
Clinical narrative: The day after the vaccine administration (1/18/14) pt suffered very low blood pressure and sugar levels. Pt is diabetic and had to took off his insulin bomb. Pt was suffering from fatigue 1/22/14 and could not breathe. Pt was hospitalized and Dx with pneumonia and a big infection in blood.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Nausea, Pleural effusion, Pneumonia, Pyrexia
Clinical narrative: The day after the vaccine administration (1/18/14) pt suffered very low blood pressure and sugar levels. Pt is diabetic and had to took off his insulin bomb. Pt was suffering from fatigue 1/22/14 and could not breathe. Pt was hospitalized and Dx with pneumonia and a big infection in blood.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 01-JUL-2013 at 07:40, ZOSTAVAX lot # J001005 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range 44.5 hours. On 01-AUG-2013 at 07:40, ZOSTAVAX lot # J001005 was exposed to -12C for an estimated total time out of range of 14 hours. On 13-AUG-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J001005, Exp. Date: 24-APR-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 12-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 1.42
Sex: F
Vaccine: DTAP
Symptoms: Eyelid oedema, Swelling face, Urticaria
Clinical narrative: Hives on left side of face. Left eyelid and under eye swollen. 2.5 mL of BENADRYL administered by mouth.
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Eyelid oedema, Ocular hyperaemia, Pruritus
Clinical narrative: Received - Flu vaccine "non-allergic/latex free type. Developed puffy, reddened eyes, tighten in chest and moderate." Itching approx 7 hrs s/p injection. Medicated with BENADRYL 25mg PO.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Pruritus, Rash generalised, Rash macular
Clinical narrative: Macular rash developed all over body 3 hrs after HPV vaccine. Pt has itchiness but no dyspnea or vomiting.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 01-JUL-2013 at 07:40, ZOSTAVAX lot # J001005 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 44.5 hours. On 01-AUG-2013 at 07:40, ZOSTAVAX lot # J001005 was exposed to -12C for an estimated total time out of range of 14 hours. On 15-AUG-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J001005, Exp. Date: 24-APR-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 23-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 03-MAR-2012 at 11:30 ZOSTAVAX (Lot # 672476/1605AA) was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 15-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 672476/1605AA, expiration date 13-JAN-2013) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2012 at 11:30 ZOSTAVAX (Lot # 672476/1605AA) was exposed to -12 degrees C for an estimated total time out of range of 4 hours.  on 14-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 672476/1605AA, expiration date 13-JAN-2013) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Electromyogram normal, Injected limb mobility decreased, Injection site discomfort, Injection site pain, Injection site reaction
Clinical narrative: Severe pain and stiffness in arm near injection site. Unable to lift arm and unable to get comfortable due to severe pain.
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Severe pain and stiffness in arm near injection site. Unable to lift arm and unable to get comfortable due to severe pain.
Age: 10.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Acute disseminated encephalomyelitis, Headache, Immunoglobulin therapy, Laboratory test abnormal, Mental status changes
Clinical narrative: Symptoms of headache, fever, and vomiting for many days, leading to eventually weakness in the upper/lower extremities, altered mental status, and loss of bladder control. Diagnosed clinically and radiographically with acute disseminated encephalomyelitis (ADEM). She received high dose solumedrol, followed by a steroid taper. She relapsed approximately one month later, and required re-hospitalization and IVIg.
Age: 10.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging brain abnormal, Pyrexia, Urinary incontinence, Vomiting
Clinical narrative: Symptoms of headache, fever, and vomiting for many days, leading to eventually weakness in the upper/lower extremities, altered mental status, and loss of bladder control. Diagnosed clinically and radiographically with acute disseminated encephalomyelitis (ADEM). She received high dose solumedrol, followed by a steroid taper. She relapsed approximately one month later, and required re-hospitalization and IVIg.
Age: 10.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Fatigue, Headache, Hyperacusis, Laboratory test, Lumbar puncture
Clinical narrative: Symptoms of headache, fever, and vomiting for many days, leading to eventually weakness in the upper/lower extremities, altered mental status, and loss of bladder control. Diagnosed clinically and radiographically with acute disseminated encephalomyelitis (ADEM). She received high dose solumedrol, followed by a steroid taper. She relapsed approximately one month later, and required re-hospitalization and IVIg.
Age: 10.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Neck pain, Photophobia, Vomiting
Clinical narrative: Symptoms of headache, fever, and vomiting for many days, leading to eventually weakness in the upper/lower extremities, altered mental status, and loss of bladder control. Diagnosed clinically and radiographically with acute disseminated encephalomyelitis (ADEM). She received high dose solumedrol, followed by a steroid taper. She relapsed approximately one month later, and required re-hospitalization and IVIg.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Herpes zoster, Pain, Rash
Clinical narrative: Developed shingles about 10 days after flu vaccine. Extreme pain and rash on torso and back. Doctor confirmed shingles virus on 1/20/2014. This is the 2nd time I've had the virus. Being treated with Acyclovir and Tramadol.
Age: 23.0
Sex: M
Vaccine: ANTH, MMR, SMALL, TYP, ANTH, MMR, SMALL, TYP
Symptoms: Chest discomfort, Computerised tomogram, Dyspnoea, Electrocardiogram, Laboratory test
Clinical narrative: Midsternal chest pressure, difficulty breathing.
Age: 23.0
Sex: M
Vaccine: ANTH, MMR, SMALL, TYP, ANTH, MMR, SMALL, TYP
Symptoms: Blood test, Chest discomfort, Computerised tomogram, Dyspnoea, Electrocardiogram
Clinical narrative: Midsternal chest pressure, difficulty breathing.
Age: 0.27
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site rash
Clinical narrative: Both injections sites, left and right thigh, had a raised rash around injection site. (Pentacel and Pneumococcal vaccine). Then rash spread from injection site up to crease in leg and to knee.  This also happened with the Hep B vaccine given at one month old.
Age: 1.54
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea, possible headache, vomiting.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Client called HD this am and reported that she noted small red welts on neck and arms on am of 1/18/2014, two days after receiving Tdap vaccine. Today she reports appearance of welts on abdominal area, now with itching. Denied any SOB or wheezing. Instructed to follow up with her medical provider and to take antihistamines as needed. Will follow up with client in next few days.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 03-MAR-2012 at 11:30 ZOSTAVAX (Lot # 672476/1605AA) was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 16-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 672476/1605AA, expiration date of 13-JAN-2013) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 01-JUL-2013 at 07:40, ZOSTAVAX lot # J001005 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 44.5 hours. On 01-AUG-2013 at 07:40, ZOSTAVAX lot # J001005 was exposed to -12C for an estimated total time out of range of 14 hours. On 20-AUG-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J001005, Exp. Date: 24-APR-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14.25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to an exact time not recorded, noted as equal to or >12C for an estimated total time out of range of 10.5 hours. On 11-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of an unknown age and gender. On 02-FEB-2001, the patient was vaccinated with the first dose of RECOMBIVAX HB. On 02-MAR-2001, the patient was vaccinated with the second dose of RECOMBIVAX HB and on 27-APR-2001, the patient was vaccinated with the third dose of RECOMBIVAX HB. On 27-APR-2001, as the third dose for this patient was administered 2 months after the first one. The outcome of as the third dose for this patient was administered 2 months after the first one was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12C for an estimated total time out of range of 14 hours. On 20-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 03-SEP-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 72 hours. On 05-SEP-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J003360, Exp. Date: 21-JUN-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not reported, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 11-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2013 at 11:30 ZOSTAVAX (Lot # 672476/16055AA) was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 22-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 672476/1605AA, expiration date 13-JAN-2013) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2012 at 11:30 ZOSTAVAX (Lot # 672476/1605AA) was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 21-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 672476/1605AA, expiration date 13-JAN-2013) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: After given Boostrix, Varicella, IPV, Havrix, Engerix-B, Menveo, and MMR had an episode of syncope, Pt was placed on floor with legs elevated, cold compress applied to forehead and took sips of water, patient recovered within 5 minutes, patient remained in seat with parents beside him for 20 minutes and felt fine after that time and parents agreed to take him home.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swelling to injection site.
Age: 1.31
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Balance disorder
Clinical narrative: My son appears drunk and very out of balance. This also happened after his vaccinations three months ago as well.
Age: 0.43
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local redness and swelling at injection site.  Quarter sized to right thigh.
Age: 1.48
Sex: F
Vaccine: UNK
Symptoms: Respiratory distress
Clinical narrative: Respiratory distress and given 2 epi pens by home nurse, whom was present.
Age: 30.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: Pt became pale and diaphoretic after immunization, patient was assisted to a reclining chair with their legs elevated and a cool compress applied to face, Vital signs were stable 110/80 bp, 76 pulse, Respirations 17, no s/sx of respiratory distress, no hives or uticaria. Pt remained conscious, was alert and oriented. 911 was called and pt was evaluated by the Woburn fire department, the patient  refused hospitialization. Pt stated he was feeling better and went home.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed symptoms of fever > 103, pain, swelling, erythema at injection site approx. 5 PM after receiving injections. 24 hrs later fever still > 103, lethargic, myalgia, headache and inj site swelling progressed. Approx 48 hrs after inj pt became unconsciousness and pupils fixed and dilated. Admitted to ICU and diagnosed with severe cellulitis, periph edema. Pt treated with IV levofloxacin fluids and placed on ventilation.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Intensive care, Lethargy, Loss of consciousness, Mechanical ventilation, Myalgia
Clinical narrative: Patient developed symptoms of fever > 103, pain, swelling, erythema at injection site approx. 5 PM after receiving injections. 24 hrs later fever still > 103, lethargic, myalgia, headache and inj site swelling progressed. Approx 48 hrs after inj pt became unconsciousness and pupils fixed and dilated. Admitted to ICU and diagnosed with severe cellulitis, periph edema. Pt treated with IV levofloxacin fluids and placed on ventilation.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pupil fixed, Pyrexia
Clinical narrative: Patient developed symptoms of fever > 103, pain, swelling, erythema at injection site approx. 5 PM after receiving injections. 24 hrs later fever still > 103, lethargic, myalgia, headache and inj site swelling progressed. Approx 48 hrs after inj pt became unconsciousness and pupils fixed and dilated. Admitted to ICU and diagnosed with severe cellulitis, periph edema. Pt treated with IV levofloxacin fluids and placed on ventilation.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Irritability, Screaming
Clinical narrative: Patient's mother told me on 01/22/14 (our first conversation to supply me with information you need) she administered the age appropriate dose of TYLENOL to patient on the way to her appointment and 4 hours later, patient began crying and screaming upon arrival at home (approx. 10:40-10:45). No fever, but would not let mom lay her down. She finally fell asleep in mom's arms, but remained fussy that night with her daddy (mom went to work). She did not call or come by to inform our office until Dec 4, 2013.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Local swelling, Swelling face, Urticaria
Clinical narrative: Urticaria. Pt called at 11:46 AM complaining of swelling in face and arms. Had received HPV at 9:42 AM. BENADRYL given in office.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Skin warm, Swelling
Clinical narrative: Complains of severe pain in left arm; difficulty in raising arm; area approximately 3 inch in diameter appears red and warm to touch. Very minimal swelling. Advised to use ice and antihistamine for redness.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Injection site swelling, Skin warm
Clinical narrative: 7.5x5 cm area - red and warm to touch. Non indurated swelling (L) arm around puncture site.
Age: 18.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Loss of consciousness, Vision blurred
Clinical narrative: Patient received flu vaccine and passed out a few minutes later while still in the store. Patient complained of dizziness and slightly blurred vision after regaining consciousness moments later. Ambulance was called and patient was taken to emergency room.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash
Clinical narrative: Patient called 1/22/14 to tell me she had a reaction and went to Dr. with a rash and burning sensation around her breast. Dr. diagnosed with shingles. She waited until 1/21/14 to go to MD office. Dr. gave VALTREX 1gm tid x 7d.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Injection site pain, Neck pain
Clinical narrative: Patient says she had shooting pain when vaccine was administered. She felt it in her neck and back. She still has some residual pain but it is now starting to get better.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Pt dx with VZ 1-14-14. Rx for acyclovir given. Sib also Dx with VZ. Both pts are up to date with vaccines including varicella. Unsure if episode qualifies as "failed vaccine" - ordered by physician to report. Sib also Dx'd.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Varicella
Clinical narrative: Pt seen in ofc sx: fever x 2d, "bumps" on chin. Dx: varicella - no Rx given - unsure if qualifies as "failed vaccine". Ordered by physician to report. Also advised by vaccine rep. to report.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Scab, Varicella post vaccine
Clinical narrative: Sib Dx'd with VZ, pt seen for routine well care and had healing scabs from VZ. No Rx given. 2nd dose of VZ and MMR held by Dr order d/t recent illness of VZ. Pt to f/u for vaccination in 2 mo. Unsure if qualifies for "vaccine failure". Ordered by dr to report.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Convulsion, Loss of consciousness, Palpitations, Syncope
Clinical narrative: Patient said heart was racing, advised her to sit, relax and take off coat/scarf. Offered to take B.P. pt said no, tried to stand to walk and collapsed on floor. Unconscious, then had seizure. Taken to hospital where pt check herself out and refused further treatment.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient received a flu vaccine on 12/6/13. He experienced severe soreness in his arm after receiving the vaccine. Patient contacted his Dr. and is now on a 10 day course of anti-inflammatory.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: The RPH administered the flu vaccine. Within 5 minutes after having a flu shot, patient fainted while he was at the pharmacy waiting area. The wife called 911 immediately. The paramedic team arrived within 15 minutes, took his blood pressure (90 palpitations). The paramedic team informed the patient that he would be fine; however, they must take him to the ER to monitor his blood pressure condition and give I.V. Prior to administering the flu vaccine, patient report to RPH that he has not had any allergy conditions to eggs, any medications and flu shots. Patient was in good health condition prior to having the flu shot. Patient did express after the fact that he was afraid of needles, and complained that he was dizzy and nausea. Patient had one dose (0.5 ml) of FLULAVAL 2013/2014, IM route, Left, Lot # HK75L, expiration date: 06/2014.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 13-DEC-2013 at 17:30 ZOSTAVAX (Lot # J007858) was exposed to a temperature noted as equal to or >12 degrees C for an estimated total time out of range of 9.75 hours. On 13-DEC-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # J007858, expiration date 28-SEP-2014) (dose and route administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 30-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 02-MAY-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for am estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, not as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 15-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not reported) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-SEP-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to an exact T not recorded but noted as equal to or >13C for an estimated total time out of range of 72.0 hours. On 10-SEP-2013 at 17:30, ZOSTAVAX lot # J003360 was exposed to -13C for an estimated total time out of range of 10 hours. On 16-SEP-2013 at 17:30, ZOSTAVAX lot # J003360 was exposed to -14C for an estimated total time out of range of 10 hours. On 25-SEP-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to 11C for an estimated total time out of range of 14 hours. On 07-OCT-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to an exact T not recorded bu tnoted as equal to or <12C for an estimated total time out of range of 42.5 hours. On 07-OCT-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J003360, Exp. Date: 21-JUN-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 03-MAR-2012 at 11:30am, ZOSTAVAX lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 07:30am, ZOSTAVAX lot # 672477/1604AA was exposed to -12 C for am estimated total time out of range of 14 hours. On 03-MAY-2012, the patient was administered an out of range dose of ZOSTAVAX lot # 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not reported, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 20-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 03-SEP-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to an exact T not recorded but noted as equal to or > 12C for an estimated total time out of range of 72.0 hours. On 10-SEP-2013 at 17:30, ZOSTAVAX lot # J003360 was exposed to -13C for an estimated total time out of range of 10 hours. On 16-SEP-2013 at 17:30, ZOSTAVAX lot # J003360 was exposed to -14C for an estimated total time out of range of 10 hours. On 25-SEP-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to 11C for an estimated total time out of range of 14 hours. On 07-OCT-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to an exact T not recorded but noted as equal to or <12C for an estimated total time out of range of 42.5 hours. On 15-OCT-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J003360, Exp. Date: 21-JUN-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours, 20 min. On 26-OCT-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H012576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist, via company representative, refers to a female patient of unknown age. On an unknown date, in the past, that patient received an unspecified dose of ZOSTAVAX (dose, route and lot number were not reported) and on an unspecified date developed "a rash up and down and inside and outside of her from top to bottom". Patient took no other medications. There were no other symptoms. The outcome of rash up and down and inside and outside of her arm from top to bottom was not reported. The relationship between ZOSTAVAX and event was not reported. Patient seek medical attention: contacted pharmacy. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 25-NOV-2013 at 7:45, ZOSTAVAX (Lot # J008434) was exposed to -12 degrees C for an estimated total time out of range of 42.75 hours. On 02-DEC-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # J008434, expiration date 11-OCT-2014) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 03-SEP-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 72.0 hours. On 10-SEP-2013 at 17:30, ZOSTAVAX lot # J003360 was exposed to -13C for an estimated total time out of range of 10 hours. On 10-SEP-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J003360, Exp. Date: 21-JUN-2014). No adverse experience had been reported. This is one 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not reported, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 13-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 26-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to currently 17 year male patient. The reporter stated that on an unknown date, the patient was administered the GARDASIL that was exposed to a temperature excursion (30 degrees Fahrenheit for 2 hours) (lot number and expiration date unknown), dose, route, anatomical location and dose number were not reported for an unknown indication. No adverse effect was reported. At the time of the report, date administered, vaccine lot number and expiration date, any treatment received, or possible hospital stay were not available. This is one of several reports from the same source. Additional information has been requested.