chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Patient presents for ER follow-up. He was seen in clinic on 1/22 for his WCC and received Tdap and MENACTRA. He developed swelling and itching at the site 24 hours later. No fever. Was seen at medical center on 1/24 for pain and swelling. He was diagnosed with cellulitis and placed on Clindamycin and BENADRYL q8 hours. The swelling and pain is much improved. Per notes from medical center he presented to the ER 3 days after receiving vaccinations. Exam was notable for "large area of erythema, warmth, induration and tenderness to palpation to left upper arm over deltoid. Small scab to center from injection. No fluctuance. No drainage. Small nodule palpable to anterior aspect of axilla. Tender to touch." Ultrasound was performed with impression: Cellulitis without abscess.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site scab, Injection site swelling, Injection site warmth, Nodule, Pain
Clinical narrative: Patient presents for ER follow-up. He was seen in clinic on 1/22 for his WCC and received Tdap and MENACTRA. He developed swelling and itching at the site 24 hours later. No fever. Was seen at medical center on 1/24 for pain and swelling. He was diagnosed with cellulitis and placed on Clindamycin and BENADRYL q8 hours. The swelling and pain is much improved. Per notes from medical center he presented to the ER 3 days after receiving vaccinations. Exam was notable for "large area of erythema, warmth, induration and tenderness to palpation to left upper arm over deltoid. Small scab to center from injection. No fluctuance. No drainage. Small nodule palpable to anterior aspect of axilla. Tender to touch." Ultrasound was performed with impression: Cellulitis without abscess.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Tenderness, Ultrasound scan abnormal
Clinical narrative: Patient presents for ER follow-up. He was seen in clinic on 1/22 for his WCC and received Tdap and MENACTRA. He developed swelling and itching at the site 24 hours later. No fever. Was seen at medical center on 1/24 for pain and swelling. He was diagnosed with cellulitis and placed on Clindamycin and BENADRYL q8 hours. The swelling and pain is much improved. Per notes from medical center he presented to the ER 3 days after receiving vaccinations. Exam was notable for "large area of erythema, warmth, induration and tenderness to palpation to left upper arm over deltoid. Small scab to center from injection. No fluctuance. No drainage. Small nodule palpable to anterior aspect of axilla. Tender to touch." Ultrasound was performed with impression: Cellulitis without abscess.
Age: 61.0
Sex: U
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt states arm is painful at all times and pain increases upon movement. The pain is not improving and the shot was given 18 days prior.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Periarthritis
Clinical narrative: Pain like a knot I couldn't lift my arm only half way. I started physical therapy. I have frozen shoulder. It hurt hot and cold put on shoulder.
Age: 79.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash erythematous
Clinical narrative: Vaccine for shingles given at 9:15 AM on 1/10/14. On 1/14/14 breaking out started on chest, upper back, around neck and later on face. On Friday 1/17/14 the rash was dark red with blisters and had become extremely painful, went to emergency room at hosp, where shingles was confirmed and prescriptions given for antiviral, pain.
Age: 60.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Cellulitis, Erythema
Clinical narrative: Patient received a TDAP rt deltoid and ZOSTAVAX in right posterior upper arm 12/14/13. Then noticed mild erythema on 12/19 and 12/20 was seen by myself for cellulitis extending 10.5 X 5.5cm.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Myalgia, Pain in extremity, Tendonitis, X-ray limb
Clinical narrative: Left arm hurt immediately after injection. Thought this would go away after a few days. By 11/13/13 my whole arm was hurting - muscle very. My rheumatologist ordered med dose pack of cortisone. This helped some but all of symptoms did not resolve. Arm continued to hurt and ache. Finally saw PCP on 12/31/13. She said I had tendonitis. Sent to Ortho Dr. given cortisone shot and sent to physical therapy.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Patient states she has a swollen, painful, pink lump approximately 1/2 apple in size at injection site.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Feeling hot, Infection, Rash, Swelling
Clinical narrative: Infection - swollen - diarrhea - heat and rash. Precautious - Went to my health facility for prednisone, Amoxicillin and fluconazole tablets!!
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Pt. reports experiencing (Rt) arm pain from insertion site, radiating down (Rt) upper to lower forearm with "tingling" in (Rt) 4th and 5th digits.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Patient's arm is red and warm a few inches below injection site started morning after vaccine.
Age: 17.0
Sex: M
Vaccine: FLUN4
Symptoms: Cellulitis
Clinical narrative: Pt received FLUMIST on 1/21/14 and developed nasal cellulitis on 1/26/14 and was treated.
Age: 21.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Vaccines given on 01/16/14 14 x 17 cm area warm erythema on left upper arm - Treatment BENADRYL and TYLENOL.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: 01/10/2014 Mild, other. Parent noticed a high temp (101 degrees Fahrenheit was the highest) and flat red dots on patient's belly on 1/10/14. His mother said the dots looked like someone had dotted him with a marker. The dots spread to his entire body and became bumps on 1/13/14. The mother gave TYLENOL for the fever and put Vaseline lotion on the dots. Patient was seen by doctor who initially thought that the reaction may have had something to do with patient's brother possibly having Fifth disease. The spots went away soon after the doctor's visit.
Age: 15.0
Sex: M
Vaccine: HEP, HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse event noted. Wrong vaccine administered in error.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Pain in extremity, Syncope, Vomiting
Clinical narrative: Patient received the Tdap vaccine on 1-29-14. He never developed a fever or any other sx. He slept fine. The next morning 1/30 he awoke with a sore arm 10 min later he felt dizzy, vomited, then fainted. He was fine the rest of the day.
Age: 43.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Patient was given vaccines on 1/27/14 on right deltoid. He presented 1/31/14 with redness and pain on right deltoid, not to the touch on affected area - patient reported fever as high as 103, at clinic temperature was reported at 98.3. PCP treated patient with a course of prednisone 20 mg for 7 days.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Irritability, Oral administration complication, Vomiting projectile
Clinical narrative: Severe projectile vomiting after putting one drop into mouth, would be fussy, vomit, and stop vomiting afterwards. Would still be a bit fussy but calmed easily. No fever, rm temp 72 degrees.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Site reaction, redness, warmth pain.
Age: 46.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Erythema, Hypersensitivity, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm began to feel sore and swell; warm to touch. Swelling also under arm. States used ice packs and heat and Motrin without relief. Worsened over weekend. Unable to lift arm, swelling red and size of an egg.  Red patches also seen one lower arm. Referred to PP or emergency room.
Age: 46.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Local swelling, Mobility decreased
Clinical narrative: Left upper arm began to feel sore and swell; warm to touch. Swelling also under arm. States used ice packs and heat and Motrin without relief. Worsened over weekend. Unable to lift arm, swelling red and size of an egg.  Red patches also seen one lower arm. Referred to PP or emergency room.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms, aching muscles.
Age: 32.0
Sex: M
Vaccine: MMR
Symptoms: Full blood count normal, Lymphadenopathy
Clinical narrative: Tender diffuse posterior cervical adenopathy.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood immunoglobulin M, Rash vesicular, Varicella virus test
Clinical narrative: Zoster like rash under her left breast.
Age: 73.0
Sex: F
Vaccine: TD
Symptoms: Musculoskeletal pain, Vaccination complication
Clinical narrative: Sitting at computer when I experienced excruciating pain in my right shoulder area - felt like bones were crushing.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema
Clinical narrative: Localized red area, aprox. 3 inc diameter.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Localized red area, aprox. 3 inc diameter.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Oropharyngeal discomfort
Clinical narrative: Localized red area, aprox. 3 inc diameter.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Induration, Influenza, Mass, Nausea
Clinical narrative: Flu symptoms with nausea and headache within 24 hours.  Hard lumps on right side of upper skull as of today with more flu symptoms.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Cough, Cyanosis, Rash, Rash erythematous
Clinical narrative: (From the medical record)  Patient received flu vaccine.  In less than 5 minutes she started to cough and have perioral cyanosis.  The nurse was in the room giving sibling vaccines and called me into the room immediately.  She was placed on the bed, cool towel placed on forehead.  Pulse ox placed, SaO2 was in 80's, oxygen given by face mask.  An erythematous rash was noted on her face and chest.  Benadryl 25 mg was given orally.  Her oxygen saturation came up in the 90's, color returned.  No LOC.  Epi was at bedside, but not needed.  Her head was slightly elevated, she was able to take sips of apple juice, the rash faded.  The oxygen was withdrawn and sats remained in high 90's.  She complained of a stomachache.  No emesis.  She was observed for 20 minutes after the oxygen was removed.  No wheezing or difficult breathing.  Able to swallow easily.  No rash.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Patient developed redness and swelling (7.0 x 7.5 cm) at site of injection with 3 vesicular lesions at injection site.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a nurse refers to a 67 year old male patient. Pertinent medical history and drug reactions or allergies was reported as none. On 10-DEC-2013 the patient was vaccinated with ZOSTAVAX, 0.65 milliliters, subcutaneous for vaccination. Concomitant medications were none. On 10-DEC-2013, the patient experienced lingering joint pain in the right shoulder and itching and on his right arm, rash on his right arm the same day he received ZOSTAVAX. The only issue the patient still had was lingering joint point. Treatment given was BENADRYL and DECADRON injection. Patient sought medical attention and contacted the physician. There was no product quality complaint (PQC) involved. The outcome of itching and on his right arm and rash on his right arm is unknown. The outcome of lingering joint pain in the right shoulder was reported as not resolved. Causality assessment was not provided. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Fatigue, Pyrexia, Tremor
Clinical narrative: Shaking chills, fever lasted 4 hours then fatigue for 12 hours.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness/discomfort injection site. Swelling of left upper arm, warm to touch. Pink discoloration of upper left arm. Cellulitis at injection site.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Soreness/discomfort injection site. Swelling of left upper arm, warm to touch. Pink discoloration of upper left arm. Cellulitis at injection site.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Raised red bump at injection site. Area is "sore and itchy."
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a 24 year old female consumer. Patients concurrent condition and medical history were not reported. On an unknown date, the patient received the first dose of GARDASIL, dose unspecified, without experiencing any adverse effects. On an unknown date, the patient had received second dose of GARDASIL, dose unspecified without experiencing any adverse effects. Concomitant therapy was reported as none. It was reported that the patient had a enquiry regarding to have shoulder surgery within days of receiving her upcoming third (3rd dose) and final dose of GARDASIL. Consumer was inquiring on how it will affect the efficacy of GARDASIL administration. The patient did not seek medical attention. No product quality complaint involved. The outcome event was unknown. The reporters causality assessment for the event with the therapy of GARDASIL was unknown. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain in (R) upper arm, pain with any movement of shoulder or elbow. No signs of infection; no significant swelling, erythema or induration. No specific treatment prescribed. Pt. reassured and told to follow-up if symptoms don't resolve next wk.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site (left deltoid) - treated possible cellulitis w/ cephalexin 500mg tid x 14 days, BENADRYL 25mg Q 6 hours and cetirizine 10mg qd PRN.
Sex: U
Vaccine: VARCEL
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 30-OCT-2013, the patient was administered with a dose of VARIVAX (Lot # J004162, expiry date 08-APR-2015) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 1.16
Sex: F
Vaccine: HEPA, HIBV, MMRV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.47
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Agitation, Crying, Insomnia, Pyrexia, Somnolence
Clinical narrative: Agitated, sleepiness, and forceful vomiting. Baby could not keep anything in his stomach for 6 hours without vomiting immediately. Baby was staring blankly and not responsive for two short periods on 1/30. Baby had a fever of over 101, treated with Tylenol. As of 1/31/14 baby now experiencing increased agitation, prolonged crying, and insomnia.
Age: 0.47
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Staring, Unresponsive to stimuli, Vomiting projectile
Clinical narrative: Agitated, sleepiness, and forceful vomiting. Baby could not keep anything in his stomach for 6 hours without vomiting immediately. Baby was staring blankly and not responsive for two short periods on 1/30. Baby had a fever of over 101, treated with Tylenol. As of 1/31/14 baby now experiencing increased agitation, prolonged crying, and insomnia.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt. came back to the clinic with complaining of hives and itching on bilateral lower legs.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Feeling abnormal, Headache, Injection site pain, Myalgia
Clinical narrative: Patient received the third and final dose of the Hepatitis B adult vaccine series on 1/16/2014.  The patient called 1/24/2014 to report that she had experienced headache, dizziness, nausea without vomiting, and left arm and neck muscle soreness since waking up the morning of 1/17/2014.  Patient states she went to exercise class on 1/17/2014 and the symptoms "got worse for a few days and then started getting a little bit better."  She was unable to give exact days of exacerbation and decreasing of symptoms.  The patient reported she called her primary care physician and was told to take over the counter Bonine.  She states this lessened the symptoms but "made me loopy, so I only took one dose on Thursday evening" (1/23/2014)  As per the conversation on 1/24/2014, patient states she still has arm and neck muscle soreness with some headache, nausea and dizziness, but that it has decreased from the initial onset on 1/15/2014.  RN advised patient of listed side effects and adverse reactions of the Hepatitis B vaccine listed by the CDC, including headache and soreness at the injection site.  RN also advised patient of the possibility that symptoms could indicate other problems, some possibly serious, that are not vaccine related.  RN advised patient that she should seek medical attention for worsening or persisting symptoms.  RN requested patient keep HD apprised of any further symptoms or concerns, or if further medical care is rendered.  Patient verbalizes understanding, denies other questions or concerns.   RN called to follow up with patient on 1/28/2014 and left message.  Patient returned phone call 1/30/2014.  Patient states she "is feeling better every day," denies further complaints.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Nausea
Clinical narrative: Patient received the third and final dose of the Hepatitis B adult vaccine series on 1/16/2014.  The patient called 1/24/2014 to report that she had experienced headache, dizziness, nausea without vomiting, and left arm and neck muscle soreness since waking up the morning of 1/17/2014.  Patient states she went to exercise class on 1/17/2014 and the symptoms "got worse for a few days and then started getting a little bit better."  She was unable to give exact days of exacerbation and decreasing of symptoms.  The patient reported she called her primary care physician and was told to take over the counter Bonine.  She states this lessened the symptoms but "made me loopy, so I only took one dose on Thursday evening" (1/23/2014)  As per the conversation on 1/24/2014, patient states she still has arm and neck muscle soreness with some headache, nausea and dizziness, but that it has decreased from the initial onset on 1/15/2014.  RN advised patient of listed side effects and adverse reactions of the Hepatitis B vaccine listed by the CDC, including headache and soreness at the injection site.  RN also advised patient of the possibility that symptoms could indicate other problems, some possibly serious, that are not vaccine related.  RN advised patient that she should seek medical attention for worsening or persisting symptoms.  RN requested patient keep HD apprised of any further symptoms or concerns, or if further medical care is rendered.  Patient verbalizes understanding, denies other questions or concerns.   RN called to follow up with patient on 1/28/2014 and left message.  Patient returned phone call 1/30/2014.  Patient states she "is feeling better every day," denies further complaints.
Age: 10.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Asthenia, Dehydration, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: FATIGUE, DIZZINESS, BRAIN FOG, HEAT INTOLERANCE, DEHYDRATION, TACHYCARDIA, WEIGHT LOSS, BLOOD POOLING IN FEET, WEAKNESS. POTS- POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME.
Age: 10.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Postural orthostatic tachycardia syndrome, Tachycardia, Temperature intolerance, Venous insufficiency, Weight decreased
Clinical narrative: FATIGUE, DIZZINESS, BRAIN FOG, HEAT INTOLERANCE, DEHYDRATION, TACHYCARDIA, WEIGHT LOSS, BLOOD POOLING IN FEET, WEAKNESS. POTS- POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Myositis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Left deltoid redness, pain, tenderness, fever began about 5 hours post injection. Fever up to 103.  Admitted to hospital 2 days later with cellulitis, myositis, WBC 19,000. Treated with IV antibiotics, managed by ID consult.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin oedema, Ultrasound scan normal, White blood cell count increased
Clinical narrative: Left deltoid redness, pain, tenderness, fever began about 5 hours post injection. Fever up to 103.  Admitted to hospital 2 days later with cellulitis, myositis, WBC 19,000. Treated with IV antibiotics, managed by ID consult.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, HIBV, IPV, PNC13, RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Single dose of IPV and Pediarix were given at the same time.  No adverse outcome.
Age: 32.0
Sex: M
Vaccine: TYP
Symptoms: Erythema, Feeling abnormal, Headache, Lymphadenopathy, Pruritus
Clinical narrative: Pt self inoculated 25 time in left deltoid. Reported local redness, itching. Headache. Fever. Swollen lymph nodes, and feeling lousy. Pt was treated with Advil and antibiotics to cover possible infections. Pt returend on 30Jan14 and all smallpox sites had scabbed up and redness was gone.
Age: 32.0
Sex: M
Vaccine: TYP
Symptoms: Pyrexia, Scab
Clinical narrative: Pt self inoculated 25 time in left deltoid. Reported local redness, itching. Headache. Fever. Swollen lymph nodes, and feeling lousy. Pt was treated with Advil and antibiotics to cover possible infections. Pt returend on 30Jan14 and all smallpox sites had scabbed up and redness was gone.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Hot to touch, red and swelling to area.
Age: 44.0
Sex: M
Vaccine: TTOX
Symptoms: Headache, Pain
Clinical narrative: Headache and severe generalized body aches for the next 24 hours.
Age: 1.07
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Pyrexia, Varicella post vaccine
Clinical narrative: Fever, chickenpox lesions over whole body and at injection site.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: NO ADVERSE EVENT noted. Patient was administered a dose of intranasal flu vaccine that was expired.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMR, VARCEL
Symptoms: Asthenia, Ataxia, CSF glucose normal, CSF protein decreased, Computerised tomogram head normal
Clinical narrative: On 1/29 afernoon he had 1 emesis. Next day early AM he had 2 more episodes of emesis and at 6am his mother noticed that he was weak and with a funny walk (ataxia).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMR, VARCEL
Symptoms: Gait disturbance, Nuclear magnetic resonance imaging brain normal, Vomiting
Clinical narrative: On 1/29 afernoon he had 1 emesis. Next day early AM he had 2 more episodes of emesis and at 6am his mother noticed that he was weak and with a funny walk (ataxia).
Age: 15.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: NO ADVERSE EVENT - Patient received expired intranasal flu vaccination.
Age: 1.23
Sex: F
Vaccine: YF
Symptoms: Pyrexia
Clinical narrative: Fever in evening, and at several points next day.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Influenza virus test negative, Laboratory test normal, Pyrexia, Rash, Streptococcus test negative
Clinical narrative: 1/21: Fever for 4 days, spiked at 103.5. 1/24: Went to Dr. Tested for strep, flu and ear infection, all negative. Faint rash noticed. 1/24: Faint rash noticed on belly, slightly more noticeable everyday. As of 1/31 is more noticeable, only on belly area and looks like mild mump like rash.  My little was extremely miserable 1/22-1/25, not sleeping and not acting like herself. I am still bothered by how she is reacting to the shot and nervous that this will keep causing problems.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Severe urticaria. Recommended antihistamine (oral or topical).
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Joint stiffness, Pyrexia, Staring, Vomiting
Clinical narrative: First my child had 105.1 fever within 36 hours. She also vomited for a week after she ate ANYTHING. Being a breastfed baby, she did well with breastmilk, baby food & soft foods until after this shot. She never had vomited before. Next, all her joints would be stiff at different times for 10 days. Lastly, she would often stare of into space for several minutes at a time (5-10). This lasted about a month. She was in a daze. Also, she had never done this before. It was months before she returned to her normal self.
Age: 0.18
Sex: M
Vaccine: HIBV
Symptoms: Bezoar, Convulsion, Decreased appetite, Dehydration, Electroencephalogram
Clinical narrative: Patient developed a fever and was listless beginning that evening. Overnight, he developed higher fever and had three seizures. He stopped eating formula and breastmilk, and began vomiting within 24 hours. He eventually became dehydrated and was admitted to the hospital.
Age: 0.18
Sex: M
Vaccine: HIBV
Symptoms: Listless, Lumbar puncture, Pyrexia, Ultrasound scan, Vomiting
Clinical narrative: Patient developed a fever and was listless beginning that evening. Overnight, he developed higher fever and had three seizures. He stopped eating formula and breastmilk, and began vomiting within 24 hours. He eventually became dehydrated and was admitted to the hospital.
Age: 0.18
Sex: M
Vaccine: HIBV
Symptoms: X-ray, X-ray with contrast
Clinical narrative: Patient developed a fever and was listless beginning that evening. Overnight, he developed higher fever and had three seizures. He stopped eating formula and breastmilk, and began vomiting within 24 hours. He eventually became dehydrated and was admitted to the hospital.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site pain, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Fever, nausea, headache, pain/swelling/warmth at injection site.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever, nausea, headache, pain/swelling/warmth at injection site.
Age: 1.27
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Decreased activity, Decreased appetite, Pyrexia
Clinical narrative: Pt received vaccines around 1400 on 1/30/14. 1/31/14 pt woke up with fever and maintained a fever of 102 most of the day. Pt has no other symptoms of concern. Decreased appetite and activity.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Back pain, Chills, Headache, Injection site pain, Nausea
Clinical narrative: Four hours after receiving 2nd dose RABAVERT, increased pain at injection site, into shoulder and back, down to elbow. Eight hours after injection, chills and fever. Thirteen hours after injection she had nausea and vomiting which lasted for 4 hours. On 1/31, 30 hours after injection, aches, HA, no fever.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Four hours after receiving 2nd dose RABAVERT, increased pain at injection site, into shoulder and back, down to elbow. Eight hours after injection, chills and fever. Thirteen hours after injection she had nausea and vomiting which lasted for 4 hours. On 1/31, 30 hours after injection, aches, HA, no fever.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: C/O pain and swelling x 2 days after receiving DTaP/IPV. Erythema, warmth, mild swelling upper half of (L) arm, approx. 10 cm x 9 cm diameter, limited to the extensor aspect of the arm.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 31-MAY-2013, the patient was vaccinated with ZOSTAVAX (lot # J000443 and expiry date 11-APR-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 28-JUN-2013, the patient was vaccinated with ZOSTAVAX (lot # J001693 and expiry date 08-MAY-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15f and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Dyspnoea
Clinical narrative: Patient had SOB, however also had COPD patient had to visit ER for medication. Could not be determined if vaccine caused SOB.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 24-SEP-2013, the patient was vaccinated with ZOSTAVAX (19400 PFU) (lot # J004268 and expiry date 12-JUL-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he  thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would had been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported tha the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperature up to 21F. he stated the time frame of the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his records didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot# was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported and administered. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 03-OCT-2013, the patient was vaccinated with ZOSTAVAX (lot # J004268 and expiry date 12-JUL-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15f and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 21-AUG-2013, the patient was vaccinated with ZOSTAVAX (lot # J002777 and expiry date 12-JUL-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15f and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 24-SEP-2013, the patient was vaccinated with ZOSTAVAX (lot # J004268 and expiry date 12-JUL-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15f and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 27-SEP-2013, the patient was vaccinated with ZOSTAVAX (lot # J004268 and expiry date 12-JUL-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15f and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.