chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Neck pain, Pyrexia
Clinical narrative: Information has been received from a nurse referring to a 65 year old female patient. The patient had none pertinent medical history and drug reactions/allergies. Information regarding concurrent condition was not provided. The patient denied ever receiving PNEUMOVAX 23 previously. On 04-FEB-2015 the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # K009105, expiration date 21-JAN-2016, 0.5 ml, intramuscularly in the right deltoid). Concomitant therapies included FLUZONE in left deltoid on 04-FEB-2015. On 04-FEB-2015, several hours after she received the dose, the patient developed pain at the injection site. She reported that there was no swelling, bruising, or induration at the injection site. The patient felt "feverish" on the same day but she didn't take her temperature. Over the next few days, the patient took some TYLENOL and one VICODIN, but she did not experience relief form her pain. The patient sought medical attention on 10-FEB-2015 when she went to Emergency Department. She sought medical attention because her pain in her right shoulder was radiating up to her neck and she rated her right shoulder pain as the worst pain in her life with degree "20 out of 10". The patient was experiencing limited range of motion and weakness in her right arm (from an unspecified date in February 2015). In the emergency department, the patient was not identified anything other than tense muscles (from an unspecified date in February 2015). The was treated with diazepam and no pain medication was given. The patient was reported to have been "relatively calm," and she was reluctant to take medication. The patient was referred to orthopedist for physical therapy but the nurse reported that the patient had not followed up with the recommended orthopedist consult. The patient consulted the nurse on 27-FEB-2015, and the nurse noted a decreased grip in the patient's right hand (specified date unknown). The patient was guarding the right arm, and she was performing her activities of daily living with her left arm. The patient currently had not recovered full use of her right arm. The outcome of the events was not recovered. The causality between PNEUMOVAX 23 and all events were not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: At site of injection, a rash broke out; cherry red color. Circumference size was about 1.5 inches. It itched and was very warm. I contacted my physician and he recommended Benadryl.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Diarrhoea, Hypoaesthesia, Nausea, Photophobia, Pyrexia
Clinical narrative: At around 9 hours after receiving the MCV-4 (Meningococcal) vaccine patient began running a fever. His symptoms progressed through the night into fever, nausea, diarrhea, sensitivity to light, and numbness in feet. At around 24 hours after vaccine was administered, patient's mother contacted clinic in regards to his symptoms. Clinic recommended patient to report to Emergency Room for further treatment.
Age: 51.0
Sex: M
Vaccine: MMR
Symptoms: Dry eye, Facial asymmetry, Hypoaesthesia oral, Upper-airway cough syndrome, VIIth nerve paralysis
Clinical narrative: Severe numbness of the rear tongue, post nasal drip, dry eye, noticable lack of facial symmetry.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: The patient reported to the pharmacy approximately 6 months after receiving the Fluzone HD vaccine.  The patient stated she still has lingering muscle pain in her arm and has had to visit her doctor and go through physical therapy, but the pain is still there.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Blood urine present, Haematochezia, Pneumonia pneumococcal, Pyrexia
Clinical narrative: Pneumococcal pneumonia. 102 degrees fever hospitalized for IV antibiotic treatment. Blood in stool and urine.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Dyskinesia, Eye movement disorder, Pyrexia, Respiratory arrest, Tremor
Clinical narrative: The following history took place in about 5 minutes. Then to ER. History from 23 year old brother 1) Grandparents called, saying her arms were flailing/tremoring, 2) Brother arrived on scene, her eyes rolled back, 3) She stopped breathing, 4) Heimlich done, 5) She vomited twice 6) Mom reports she was febrile most of the day but didn't take temp. No thermometer to check.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Vomiting
Clinical narrative: The following history took place in about 5 minutes. Then to ER. History from 23 year old brother 1) Grandparents called, saying her arms were flailing/tremoring, 2) Brother arrived on scene, her eyes rolled back, 3) She stopped breathing, 4) Heimlich done, 5) She vomited twice 6) Mom reports she was febrile most of the day but didn't take temp. No thermometer to check.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint injection, Nuclear magnetic resonance imaging, X-ray limb normal
Clinical narrative: Initial unsolicited case received from a healthcare professional (medical assistant) on 25 February 2015. A 54-year-old female patient, with a history of asthma, hypothyroidism, obesity, optic neuritis, depression, and generalized chronic pain, received a left arm (upper shoulder) intramuscular injection of FLUZONE (lot number UI189AA) on 08 September 2014. On 29 December 2014, the patient presented to her physician with complaints of left shoulder pain which she thought was related to her flu shot. An x-ray of the shoulder was negative. She returned to her physician on 28 January 2015 with the same complaints, at which time she was given a steroid injection in the left shoulder. On 24 February 2015 she again saw her physician with the same complaint, and was prescribed NAPROSYN and VOLTAREN Gel. An MRI of the shoulder was ordered; results were pending at the time of the report. The reporter noted that the patient had not self-treated for pain with NSAIDS or acetaminophen. Concomitant medications included AMBIEN, PROVENTIL inhaler, SYNTHROID, and SINGULAIR. Outcome was reported as unknown. Documents held by sender: None.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza, Pneumonia
Clinical narrative: Initial unsolicited report was received from a certified medical assistant on 23 February 2015. This case is one of a cluster of "almost 10 patients" received from the same reporter (with 8 patient identified). The other patients are captured in cases 2014SA157362, 2015SA023263, 2015SA023267, 2015SA023893, 2015SA023902, 2015SA023910, 2015SA023917, 2015SA023924. A 65 year-old male patient, had received on 19 December 2014 in the morning, an intramuscular left arm injection of FLUZONE QUADRIVALENT, lot number UI205AC with expiration date of June 2015 and 1 day later on 20 December 2014 the patient experienced pneumonia and flu. Illness at the time of vaccination was none, healthy. Concomitant medications and pre-existing conditions were reported as "NA". Laboratory tests were reported as unknown. No further information was provided. Outcome was recovered, date not reported. According to the reporter, the report was reviewed and they had no additional information to report at the time. Documents held by sender: none.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Death, Influenza, Influenza virus test positive, Laboratory test abnormal, Pneumonia
Clinical narrative: Initial unsolicited report was received from a certified medical assistant on 23 February 2015. This case is one of a cluster of "almost 10 patients" received from the same reporter (with 8 patients identified). The other patients are captured in cases 2014SA157362, 2015SA023263, 2015SA023267, 2015SA023902, 2015SA023910, 2015SA023917, 2015SA023924, 2015SA023928. A 74 year-old patient, gender unknown had received on 13 October 2014 in the morning, an intramuscular left arm injection of FLUZONE QUADRIVALENT, lot number UI205AC with expiration date of June 2015 and at an unspecified time after vaccination was diagnosed with flu and pneumonia; the patient died on 28 December 2014, approximately 3 months after vaccination. Relevant diagnostic tests were reported as "ER + flu + pneumonia". Illness at the time of vaccination was none. Concomitant medications and pre-existing conditions were reported as "NA". No further information was provided. Outcome was fatal. According to the reporter, the report was reviewed and they had no additional information to report at the time. Documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Dysphagia, Erythema, Injection site erythema, Pharyngeal oedema
Clinical narrative: Patient returned to clinic stating that she felt like her throat was swollen and she was having trouble swallowing.  She had redness along face, chest and right upper arm. Patient evaluated by provider and Epipen administered at 9:54 AM.  Patient was observed for 1 hour and released to home with Epipens and instructions on how and when to use them.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Irritability, Screaming
Clinical narrative: Mom reported patient slept for 5 hours following the vaccine appointment and then started crying and would not stop despite comforting. Mom was concerned and brought patient into our office about 5.30pm. Upon exam patient was extremely fussy, would not stop crying and screaming. Pt did calm down after administering 3.5ml of acetaminophen.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Gait disturbance, Injection site erythema, Pain, Swelling
Clinical narrative: Redness at site started on day of injection. Redness, swelling, pain worsened.  Difficulty walking due to pain. Seen by MD two days after injection administered. Monitoring site and will recheck again in 48 hours.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient given incorrect dose (given adult dose when child dose indicated); patient is okay, no ADE.
Age: 0.68
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Office short staffed. Pulled vaccinations alone and in a hurry. After giving vaccinations during documentation realized expired. Made provider, nursing supervisor and safety officer aware. Attempted to contact mom but unable until the next day.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Arm is sore at injection site.  I have a lump and it itches.  Feeling fatigued.
Age: 48.0
Sex: M
Vaccine: TDAP, HIBV, MNQ
Symptoms: Extra dose administered
Clinical narrative: Patient was administered a double dose of Boostrix.
Age: 48.0
Sex: M
Vaccine: TDAP, HIBV, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Patient was administered a double dose of Boostrix.
Age: 48.0
Sex: M
Vaccine: TDAP, HIBV, MNQ
Symptoms: Extra dose administered
Clinical narrative: Patient was supposed to receive Menactra (meningococcal vaccine) and instead, staff member administered Haemophilus influenzae vaccine.
Age: 48.0
Sex: M
Vaccine: TDAP, HIBV, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Patient was supposed to receive Menactra (meningococcal vaccine) and instead, staff member administered Haemophilus influenzae vaccine.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Hypoaesthesia, Laboratory test normal, Pain, Paraesthesia
Clinical narrative: Chronic pain, Chronic fatigue, Chronic numbness, Chronic tingling.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: X-ray normal
Clinical narrative: Chronic pain, Chronic fatigue, Chronic numbness, Chronic tingling.
Age: 66.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Basophil percentage, Chills, Eosinophil percentage, Injection site discomfort
Clinical narrative: Complains of site discomfort, fever, chills and joint pain.
Age: 66.0
Sex: M
Vaccine: TD
Symptoms: Lymphocyte percentage, Monocyte percentage, Neutrophil count normal, Neutrophil percentage, Pyrexia
Clinical narrative: Complains of site discomfort, fever, chills and joint pain.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Axillary pain, Chills, Injection site erythema, Oedema peripheral, Pyrexia
Clinical narrative: Pt c/o fever and chills next day, with redness on left deltoid getting progressively worse. Also c/o swelling and pain in left axillary.
Age: 20.0
Sex: F
Vaccine: MENB, UNK
Symptoms: Altered state of consciousness, Asthenia, Autonomic neuropathy, Blood test, Chills
Clinical narrative: Severe headache, severe stiff neck, chills, nausea, tiny purple dots on legs, feeling fatigue and weak, intense ringing in ears, stinging cold water (icy) spots all over body (started on arms/legs, muscle tightness, pain in fingers/hands/wrist/toes/feet/ankles, tingling in toes/fingers, sharp stabbing pain in arms/legs/thighs. Throbbing/worming wave pain fading in and out above eyebrows, pain top of head, above left eyebrow, left temple, dizziness, episode of extremely severe ringing in ears with feeling of going to pass out, light sensitivity and vertigo. Painful electric shocks in elbows, wrist, back of knees, fingers. Extreme fatigue that doesn't go away, back of neck pain. Ringing in ears that does not go away. Autoimmune autonomic neuropathy. Dizziness.  Neck stiffness. Cervical radicular pain.
Age: 20.0
Sex: F
Vaccine: MENB, UNK
Symptoms: Dizziness, Fatigue, Feeling cold, Headache, Muscle tightness
Clinical narrative: Severe headache, severe stiff neck, chills, nausea, tiny purple dots on legs, feeling fatigue and weak, intense ringing in ears, stinging cold water (icy) spots all over body (started on arms/legs, muscle tightness, pain in fingers/hands/wrist/toes/feet/ankles, tingling in toes/fingers, sharp stabbing pain in arms/legs/thighs. Throbbing/worming wave pain fading in and out above eyebrows, pain top of head, above left eyebrow, left temple, dizziness, episode of extremely severe ringing in ears with feeling of going to pass out, light sensitivity and vertigo. Painful electric shocks in elbows, wrist, back of knees, fingers. Extreme fatigue that doesn't go away, back of neck pain. Ringing in ears that does not go away. Autoimmune autonomic neuropathy. Dizziness.  Neck stiffness. Cervical radicular pain.
Age: 20.0
Sex: F
Vaccine: MENB, UNK
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Paraesthesia, Photophobia
Clinical narrative: Severe headache, severe stiff neck, chills, nausea, tiny purple dots on legs, feeling fatigue and weak, intense ringing in ears, stinging cold water (icy) spots all over body (started on arms/legs, muscle tightness, pain in fingers/hands/wrist/toes/feet/ankles, tingling in toes/fingers, sharp stabbing pain in arms/legs/thighs. Throbbing/worming wave pain fading in and out above eyebrows, pain top of head, above left eyebrow, left temple, dizziness, episode of extremely severe ringing in ears with feeling of going to pass out, light sensitivity and vertigo. Painful electric shocks in elbows, wrist, back of knees, fingers. Extreme fatigue that doesn't go away, back of neck pain. Ringing in ears that does not go away. Autoimmune autonomic neuropathy. Dizziness.  Neck stiffness. Cervical radicular pain.
Age: 20.0
Sex: F
Vaccine: MENB, UNK
Symptoms: Radicular pain, Skin discolouration, Tinnitus, Vertigo
Clinical narrative: Severe headache, severe stiff neck, chills, nausea, tiny purple dots on legs, feeling fatigue and weak, intense ringing in ears, stinging cold water (icy) spots all over body (started on arms/legs, muscle tightness, pain in fingers/hands/wrist/toes/feet/ankles, tingling in toes/fingers, sharp stabbing pain in arms/legs/thighs. Throbbing/worming wave pain fading in and out above eyebrows, pain top of head, above left eyebrow, left temple, dizziness, episode of extremely severe ringing in ears with feeling of going to pass out, light sensitivity and vertigo. Painful electric shocks in elbows, wrist, back of knees, fingers. Extreme fatigue that doesn't go away, back of neck pain. Ringing in ears that does not go away. Autoimmune autonomic neuropathy. Dizziness.  Neck stiffness. Cervical radicular pain.
Age: 20.0
Sex: F
Vaccine: MENB, UNK
Symptoms: Headache, Nausea
Clinical narrative: Severe headache, severe stiff neck, chills, nausea, tiny purple dots on legs, feeling fatigue and weak, intense ringing in ears, stinging cold water (icy) spots all over body (started on arms/legs, muscle tightness, pain in fingers/hands/wrist/toes/feet/ankles, tingling in toes/fingers, sharp stabbing pain in arms/legs/thighs. Throbbing/worming wave pain fading in and out above eyebrows, pain top of head, above left eyebrow, left temple, dizziness, episode of extremely severe ringing in ears with feeling of going to pass out, light sensitivity and vertigo. Painful electric shocks in elbows, wrist, back of knees, fingers. Extreme fatigue that doesn't go away, back of neck pain. Ringing in ears that does not go away. Autoimmune autonomic neuropathy. Dizziness.  Neck stiffness. Cervical radicular pain.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site haemorrhage
Clinical narrative: Bleeding at injection site that has not stopped.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Culture urine positive, Genital discomfort, Genital erythema, Genital pain
Clinical narrative: Developed redness, irritation and bumps to genital area that progressed to vesicles and painful ulcerations of the labia majora, labia minora and mons pubis.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Genital rash, Genital ulceration, Herpes simplex serology positive, Vulval ulceration
Clinical narrative: Developed redness, irritation and bumps to genital area that progressed to vesicles and painful ulcerations of the labia majora, labia minora and mons pubis.
Age: 17.0
Sex: M
Vaccine: HPV2
Symptoms: Wrong drug administered
Clinical narrative: THE NURSE ADMINISTERED CERVARIX TO A MALE PATIENT.
Age: 18.0
Sex: M
Vaccine: HPV2
Symptoms: Wrong drug administered
Clinical narrative: THE NURSE ADMINISTERED CERVARIX TO A MALE PATIENT.
Age: 54.0
Sex: M
Vaccine: HEPAB, MMR, PPV, TDAP, TYP
Symptoms: Immediate post-injection reaction, Injection site haematoma, Injection site nodule, Injection site pain
Clinical narrative: Right after the injection was given a knot appeared on the patients deltoid area. It looked like a small hematoma. Pt then stated he took Aspirin everyday. Pt. stated there was no pain at the site and it started to decrease in size after about 15 minutes. Instructed patient to watch the area for redness, swelling, tenderness, rash, etc. Pt was contacted the next day and said he was arm was fine. He stated there was some tenderness in the area but no longer a "knot".
Age: 28.0
Sex: M
Vaccine: FLU3, FLUC3
Symptoms: Arthralgia, Full blood count, Influenza like illness, Metabolic function test, Pain
Clinical narrative: Flu like symptoms including body aches and 100+ degree fever lasting for two days.  Body aches subsided except for joint pain, now diagnosed as Rheumatoid Arthritis.
Age: 28.0
Sex: M
Vaccine: FLU3, FLUC3
Symptoms: Pyrexia, Rheumatoid arthritis, Urine analysis
Clinical narrative: Flu like symptoms including body aches and 100+ degree fever lasting for two days.  Body aches subsided except for joint pain, now diagnosed as Rheumatoid Arthritis.
Age: 28.0
Sex: M
Vaccine: FLU3, FLUC3
Symptoms: Laboratory test, Rheumatoid arthritis
Clinical narrative: Flu like symptoms including body aches and 100+ degree fever lasting for two days.  Body aches subsided except for joint pain, now diagnosed as Rheumatoid Arthritis.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture, Cellulitis, Full blood count, Hypersensitivity, Injection site erythema
Clinical narrative: Itching, redness, hot, and sore to touch around site of injection on upper left arm. Intensified later in day, sought med. care. Diagnosis: cellulitis. Red spot now swollen, hard and 3 in. in diameter. CBC and blood cultures were taken at dr. office. Began Keflex 500 mg. twice a day for 7 days. First dose: 8:00PM on 3/6 and used hot compress as directed by dr. office.  3/7-general body aches and malaise. No fever.  3/8, advised by internist to go to urgent care. Red/purple spot now 6 in. in diameter Diagnosis: more likely to be allergic reaction to vaccine. Given 60 mg. Prednisone by mouth in office, directed to continue Keflex, and take 50 mg. Benadryl every 6 hrs. through 3/9. Use cold compress.  Red/purple itchy spot reduced in size by 3/11 but reaction still visable and itching.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Itching, redness, hot, and sore to touch around site of injection on upper left arm. Intensified later in day, sought med. care. Diagnosis: cellulitis. Red spot now swollen, hard and 3 in. in diameter. CBC and blood cultures were taken at dr. office. Began Keflex 500 mg. twice a day for 7 days. First dose: 8:00PM on 3/6 and used hot compress as directed by dr. office.  3/7-general body aches and malaise. No fever.  3/8, advised by internist to go to urgent care. Red/purple spot now 6 in. in diameter Diagnosis: more likely to be allergic reaction to vaccine. Given 60 mg. Prednisone by mouth in office, directed to continue Keflex, and take 50 mg. Benadryl every 6 hrs. through 3/9. Use cold compress.  Red/purple itchy spot reduced in size by 3/11 but reaction still visable and itching.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pain
Clinical narrative: Itching, redness, hot, and sore to touch around site of injection on upper left arm. Intensified later in day, sought med. care. Diagnosis: cellulitis. Red spot now swollen, hard and 3 in. in diameter. CBC and blood cultures were taken at dr. office. Began Keflex 500 mg. twice a day for 7 days. First dose: 8:00PM on 3/6 and used hot compress as directed by dr. office.  3/7-general body aches and malaise. No fever.  3/8, advised by internist to go to urgent care. Red/purple spot now 6 in. in diameter Diagnosis: more likely to be allergic reaction to vaccine. Given 60 mg. Prednisone by mouth in office, directed to continue Keflex, and take 50 mg. Benadryl every 6 hrs. through 3/9. Use cold compress.  Red/purple itchy spot reduced in size by 3/11 but reaction still visable and itching.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Pain in extremity, Rash
Clinical narrative: Immediately after the Menveo vaccine was administered the pt complained of pain and numbness in his arm.  Pt also instantly developed a rash that spread to torso and back.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: HAD PAIN AT IMMUNIZATION SITE AFTER THE INJECTION BUT NOTICED REDNESS ON THE INSIDE OF THE ARM 1 WK LATER W/PAIN.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: DIZZINESS.
Age: 95.0
Sex: F
Vaccine: PNC13
Symptoms: Culture negative, Herpes simplex serology negative, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Pt noted an itchy red, raised rash on her right upper arm at night. She reports that site hurt ever since the immunization but itching developed on 3/7/15.
Age: 95.0
Sex: F
Vaccine: PNC13
Symptoms: Rash pruritic
Clinical narrative: Pt noted an itchy red, raised rash on her right upper arm at night. She reports that site hurt ever since the immunization but itching developed on 3/7/15.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Cough, Pyrexia, Rash, Rhinorrhoea, Vomiting
Clinical narrative: High fever 01 am, notice rashes on the forehead eyes, behind ears, upper cheeks runny nose cough vomit one time.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Albumin CSF, Asthenia, CSF cell count normal, Demyelinating polyneuropathy, Neuralgia
Clinical narrative: Acute onset progressive weakness approximately 20Mar2014 -> typical course for Acute Demyelinating Polyneuropathy. Received Tdap on 7Mar2014. Recovering - still residual weakness/neuropathic pain.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional and refers to unspecified number of patients of unknown age and gender. The patient's medical histories, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patient were probably vaccinated with doses of improperly stored ROTATEQ (dose, anatomical location, lot# and exp. date were not reported; route of administration defaulted to oral). Concomitant therapies were not reported. No adverse effects were reported. This is one of the two reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLUC3, PPV, FLUC3, PPV
Symptoms: Chills, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a pharmacist referring to a 65 year old male patient with asthma (developed on an unspecified date prior to receive PNEUMOVAX 23) and no drug reactions/ allergies. On 23-OCT-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 lot # K009106, expiration date: 25-FEB-2016, 0.5 ml, intramuscularly. On the same day the patient received a dose of FLUCELVAX (manufacturer unspecified). Other concomitant therapies included valsartan, CELEBREX, ZETIA, albuterol and atorvastatin. On approximately 24-OCt-2014, within 24-48 hours of receiving PNEUMOVAX 23 the patient developed swelling at the injection site as well as a fever and chills. On 27-OCT-2014 the patient saw his physician for medical attention and BACTRIM was prescribed by the physician to treat the adverse events. The outcome of the adverse events was unknown. The relationship of the adverse events and PNEUMOVAX 23 was not reported. This is one of several reports (MARRS#1502USA010690; MARRS#1502USA010624) received from the same reporter. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Delivery, Exposure during pregnancy
Clinical narrative: This retrospective pregnancy case was reported by a consumer and described the occurrence of vaccine exposure during pregnancy in a 28-year-old female subject who was vaccinated with influenza vaccine (manufactured unspecified). A physician or other health care professional has not verified this report. In fall 2009, the subject received unspecified dose of Influenza vaccine (unknown route and injection site; lot number not provided). The subject's last menstrual period was on unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine during unknown trimester. On unspecified date, after unknown weeks of gestation, the subject gave birth to a live infant with no congenital anomaly, by unspecified delivery method. This is 1 of the 2 cases reported for the same subject.
Age: 77.0
Sex: U
Vaccine: FLUX
Symptoms: Cough, Nasopharyngitis
Clinical narrative: This case was reported by a consumer and described the occurrence of cough in a 77-year-old patient who received Influenza vaccine (batch number unknown, expiry date unknown). Co-suspect products included ADVAIR Diskus inhalation powder (batch number 4ZP6123, expiry date February 2016) for asthma. The patient's past medical history include colon cancer, bone cancer and pneumonia. Concomitant products included Dlicicice,FLONASE nasal spray, SPIRIVA, VENTOLIN, Vitamin D, ZOCOR, phenazone, aspirin, levalbuterol, losartan, metformin and paroxetine. On 25th December 2014, the patient received influenza vaccine (intramuscular). On an unknown date, the dose was an unknown dose. On an unknown date, the patient started ADVAIR Diskus (inhaled) 1 puff(s) at an unknown frequency. On an unknown date, the dose was changed to an unknown dose and frequency. In December 2014, less than a week after receiving Influenza vaccine and an unknown time after starting ADVAIR Diskus, the patient experienced cough. On 28th December 2014, the patient experienced cold. ADVAIR Diskus was continued with no change. On an unknown date, the outcome of the cough was not recovered/not resolved and the outcome of the cold was recovered/resolved. It was unknown if the reporter considered the cough and cold to be related to Influenza vaccine and ADVAIR Diskus.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Abdominal pain upper, Abnormal faeces, Diarrhoea, Faecal volume increased, Gastrointestinal pain
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an approximately 10 week old male patient. No medical history was reported. On 27-FEB-2015 the patient was vaccinated with ROTATEQ, (oral liquid, dose and frequency not provided, lot # K006805, expiry date 24-MAR-2016), PEDIARIX HIB and PREVNAR 13. No concomitant therapy was provided. On 27-FEB-2015, within 12 hours of receiving the vaccines, the patient developed a temperature of 99 F and mushy stools with incredibly foul odor with severe bowel cramping which was followed by massing stooling. Approximately on 01-MAR-2015, 3 days later, the patient's stomach cramping resolved. On 03-MAR-2015, the patient sought medical attention by visiting physician's office and the physician suspected intussusception, although the foetor had diminished and the intussusception was resolving but the patient was not fully recovered yet. Treatment rendered for the patient was unspecified. The patient's parents have been instructed to take patient immediately to the hospital upon any reoccurrence of pain or worsening of symptoms. The outcome of the events pyrexia, mushy stool and massing stooling was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Intussusception, Pyrexia
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an approximately 10 week old male patient. No medical history was reported. On 27-FEB-2015 the patient was vaccinated with ROTATEQ, (oral liquid, dose and frequency not provided, lot # K006805, expiry date 24-MAR-2016), PEDIARIX HIB and PREVNAR 13. No concomitant therapy was provided. On 27-FEB-2015, within 12 hours of receiving the vaccines, the patient developed a temperature of 99 F and mushy stools with incredibly foul odor with severe bowel cramping which was followed by massing stooling. Approximately on 01-MAR-2015, 3 days later, the patient's stomach cramping resolved. On 03-MAR-2015, the patient sought medical attention by visiting physician's office and the physician suspected intussusception, although the foetor had diminished and the intussusception was resolving but the patient was not fully recovered yet. Treatment rendered for the patient was unspecified. The patient's parents have been instructed to take patient immediately to the hospital upon any reoccurrence of pain or worsening of symptoms. The outcome of the events pyrexia, mushy stool and massing stooling was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left deltoid - swollen, red and sore.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Cold sweat, Nausea, Syncope
Clinical narrative: On 3/10/15 (235 pm vitals taken) Dad said she fainted in waiting room on way out of clinic. Approx 5-10 min post vaccination. Pt. alert when I got to her. Called for nurses to help. Pts stayed on floor, head between her knees, took WNL vitals, pt stated she was "going to throw up" offered her a sugar drink-pts stated she ate lunch today. Very clammy,-got her an ice pac. After thirty minutes she was up and "ok" she stated.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Productive cough, Underdose, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of expectoration in a 2-month-old female patient who received ROTARIX (batch number A41FB470A, expiry date 4th February 2016). On 28th January 2015 12:15, the patient received the 1st dose of ROTARIX (oral) 1 ml. On 28th January 2015, immediately after receiving ROTARIX, the patient experienced expectoration and underdose. On an unknown date, the outcome of the expectoration was recovered/resolved and the outcome of the underdose was unknown. It was unknown if the reporter considered the expectoration to be related to ROTARIX. Additional information: A portion of the vaccine was given to patient; she swallowed that portion without incident. Then patient received remainder of vaccine but spit it out. She spit out medication along with milk. Milk was given shortly after ROTARIX.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Nasopharyngitis
Clinical narrative: This case was reported by a consumer and described the occurrence of cold in a 74-year-old female patient who received Flu vaccine (batch number 4ZP5141, expiry date December 2015) and (batch number unknown, expiry date unknown). Co-suspect products included ADVAIR Diskus inhalation powder (batch number 4ZP5141, expiry date December 2015). In 2011, the patient received Flu vaccine. On an unknown date, the dose was an unknown dose. In January 2007, the patient started ADVAIR Diskus (inhaled) 1 puff(s) at an unknown frequency. In January 2007, the dose was changed to 1 puff(s) at an unknown frequency. On an unknown date, the dose was changed to an unknown dose and frequency. In 2011, the patient experienced cold. On 5th January 2015, the patient experienced difficulty breathing. The dose of ADVAIR Diskus was increased. On an unknown date, the outcome of the cold was recovered/resolved and the outcome of the difficulty breathing was not recovered/not resolved and the outcome of the medication dose changed was unknown. The reporter considered the cold to be almost certainly related to flu vaccine and ADVAIR diskus. The reporter considered the difficulty breathing to be unrelated to flu vaccine and ADVAIR Diskus. The reporter considered the medication dose changed to be unrelated to ADVAIR Diskus. Additional information: A female patient reports that in 2011, she received a flu shot from an unknown manufacturer. No other information about the injection was known. The patient reports that as a result of the flu shot, she needed to see a doctor three times before the event resolved. The patient also reports that on January 8, 2015 she could not taste or feel the powder. She usually tastes and feels the powder. She reports that as a result of no powder coming out, she began to run out of breath. The patent reports that she only take one puff per day. During the event, she reports increasing her doses to one puff twice daily, but this did not improve or resolve the running out of breath.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: (+) localized redness on (L) upper deltoid/arm a day after vaccine given. No DOB/wheezing, no vomiting, no abdominal pain. Redness, swelling progressed with itchiness and tenderness, given BENADRYL by mom. Started on prednisone x 3 days.
Age: 0.26
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This case was reported by a nurse and described the occurrence of threw up in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included reflux (unknown). Concurrent vaccination included PEDIARIX (GlaxoSmithKline; unknown route and injection site), ACTHIB (non-gsk) (Sanofi; unknown route and injection site) and PREVNAR 13 (non-gsk) (Wyeth Labs; unknown route and injection site), all given on 16 July 2014. On 16 July 2014, the subject received 1st dose of ROTARIX (1 ml, oral). On 16 July 2014, immediately after vaccination with ROTARIX, the subject experienced threw up. At the time of reporting, the outcome of the event was unspecified. The nurse considered the event was unrelated to vaccination with ROTARIX because the infant had reflux.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Red, very bruised (6-8), hard lump, swelling of the lower and upper arm, warm to touch, no fever.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Erythema, Induration, Mass, Peripheral swelling
Clinical narrative: Red, very bruised (6-8), hard lump, swelling of the lower and upper arm, warm to touch, no fever.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm
Clinical narrative: Red, very bruised (6-8), hard lump, swelling of the lower and upper arm, warm to touch, no fever.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Nausea, Pyrexia
Clinical narrative: This spontaneous report was received from a consumer, refers to a 45 year old male patient with hypertension, blood cholesterol increased and asthma. There were not drug reactions or allergies. On 20-FEB-2015 the patient was vaccinated with PNEUMOVAX 23 injection, subcutaneous, (strength, dosage, lot # and expiration date were not reported). Concomitant therapies included losartan, SIMVASTATIN TABLETS, USP, ZYRTEC and VENTOLIN (ALBUTEROL). On 21-FEB-2015, the patient experienced dizziness, injection site erythema, nausea and pyrexia, subsequently the patient called to his physician and was prescribed ZOFRAN, for his nausea, other therapies given as treatment for the adverse events were TYLENOL, and MOTRIN. There were not laboratories diagnostics performed. The outcome of dizziness, nausea and pyrexia was reported as recovered on 02-MAR-2015. At the time of this report, the outcome of injection site erythema was not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown gender and age. On 06-MAR-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K00726, expiration date: 09-JAN-2015), 0.65 ml, subcutaneous. No adverse effects was reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a physician assistant refers to a no pregnant 17 year old female patient. Concurrent conditions, medical history and allergies were not reproted. It was reported that the patient received a two shot regimen where 08-JAN-1999, the patient was vaccinated with the first dose of VARIVAX (Merck) (strength, dose, route, anatomical location, lot number and expiration date were not reported) and 02-SEP-2009, the patient was vaccinated wight the second dose of VARIVAX (Merck) (strength, dose, route, anatomical location, lot number and expiration date were not reported). On 25-FEB-2015, the patient experienced a mild case of varicella and it was described that the patient had less than 25 lesions, no fever and no malaise. The reporter also stated that the patient's father had shingles and the physician's assistant believed this may be why the patient got the varicella. The patient sought medical attention through office visit and no treatment was given for the adverse event. The outcome of varicella was unknown. The relatedness between varicella and therapy with VARIVAX (Merck) was not reported. Additional information is not expected, because the reproter did not consent further follow up.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional and refers to unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patients were probably vaccinated with improperly stored doses of GARDASIL (dose, route of administration, anatomical location, lot# and exp. date were not reported). Concomitant therapies were not reported. No adverse effects were reported. This is one of the two reports received from the same source. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 20 year old patient of unknown gender who on 16-FEB-2015 was inadvertently vaccinated with a dose of ZOSTAVAX (dose, lot #, expiration date and route were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None reported.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Pt picked up Rx on 3/11/15 and stated ZOSTAVAX given in December 2014 made arm swell x1 week. Swelling started approximately 6-8h after vaccine given. Pt did not report to us until 03/11/15.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontanoeus report as received from a health care professional refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. The reporter stated that doses of COMVAX (dose, route, lot number and expiry date were not reported), which were exposed to temperatures outside of the recommended range on 12-JAN-2015, had been administered to unspecified patients on unspecified dates since 12-JAN-2015. No adverse experienced was reported. Additional infromation has been requested.
Age: 1.05
Sex: M
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Otitis media, Pyrexia
Clinical narrative: 3-4-15 3:38 PM Fever, bilateral OM.
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site warmth, Myalgia
Clinical narrative: (R) upper arm erythema/warmth (17 x 16 cm) fever, muscle pains, nausea, fatigue. dizziness. Sx started evening of day of administration. Pt placed on steroid (MEDROL dose pack) 3-1-15 and BACTRIM.
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Platelet count normal, Pyrexia, Red blood cell count normal, White blood cell count normal
Clinical narrative: (R) upper arm erythema/warmth (17 x 16 cm) fever, muscle pains, nausea, fatigue. dizziness. Sx started evening of day of administration. Pt placed on steroid (MEDROL dose pack) 3-1-15 and BACTRIM.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Rash. Red, raised and itchy. About the size of baseball. Consulted MD. No action given.
Age: 82.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pt. complains pain in upper right arm since receiving vaccine. Painful to comb hair, etc. Slight throbbing in arm at rest. Has not seen doctor. Went to dr. got steroid pak- 2/24/15.
Sex: U
Vaccine: HPV2
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received BOOSTRIX. Co-suspect products included ROTARIX, PEDIARIX, KINRIX, HAVRIX, INFANRIX, and CERVARIX. On an unknown date, the patient received BOOSTRIX at an unknown dose, ROTARIX, PEDIARIX, KINRIX, HAVRIX at an unknown dose and INFANRIX at an unknown date. On 10 August 2014, the patient received CERVARIX. On an unknown date, an unknown time after receiving BOOSTRIX, ROTARIX, PEDIARIX, KINRIX, HAVRIX, INFANRIX and CERVARIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Multiple GSK vaccines were exposed to 23.5F for 340hrs between 10 August 2014 to 25 January 2015 and have been administered.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Dyskinesia, Eye movement disorder, Seizure like phenomena
Clinical narrative: Seizure like episode when leaving clinic. Developed dizziness, eyes rolled back in head, and she starting jerking lasting around 40 sec.
Age: 1.3
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Cough, Otitis media, Pyrexia, Swelling
Clinical narrative: Pt had IM shot Rt thigh at afternoon 3/10/15 - here for recheck otitis media - sibling Dx today with positive flu type B - pt fever, cough, swelling at 4:30 pm.
Age: 53.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received TWINRIX adult. On an unknown date, the patient received TWINRIX adult at an unknown dose. On an unknown date, unknown after receiving TWINRIX adult, the patient experienced injection site pain and injection site bruising. On an unknown date, the outcome of the injection site pain and injection site bruising were unknown. It was unknown if the reporter considered the injection site pain and injection site bruising to be related to TWINRIX adult.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.71
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling to (R) thigh 3/4 in x 1 in in size. Fever 100.9 F. TYLENOL as per package instructions/cool compress.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Patient received the varicella (VARIVAX) SQ (R) arm on 3/9/15. On 3/11/15 - pt. mom noticed redness with edema to (R) upper arm at site of injection. Area tender/warm to touch.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Pain in arm, radiating toward hand intermittently with limited shoulder motion.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Arm, red, swollen, hurts to move.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 10-NOV-2014, the patient was vaccinated with a dose of MMR II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 06-NOV-2014, the patient was vaccinated with a dose of M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 04-NOV-2014, the patient was vaccinated with a dose of M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 23-JAN-2015 the patient was vaccinated with MMR II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.