chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Feeling abnormal, Hypersomnia, Mechanical ventilation, Muscular weakness, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer on 9 October 2015. This case involves an 81-year-old male patient who was vaccinated with an intramuscular dose of FLUZONE (batch number, expiry date not reported) in the right arm and also received a dose of PREVNAR 13 (batch number, expiry date and route of administration not reported, manufacturer Pfizer) in right arm on 11 September 2015 at 12:00 hours. The medical history includes diabetes since 2013, cellulitis in left leg and the patient gets flu shots annually and concomitant medications were not reported. On an unspecified date after the vaccination the patient noticed that his hand was swollen. He was also complaining that his hand was hurting. The patient never complains about anything. He went to the emergency and they slammed him into the hospital, he went to the Urgent Care and they were not able to x-ray his hand to see what was going on with it. So the patient was taken to the emergency. The reporter thought that the patient was admitted in hospital for hand but was surprised to see the patient on breathing apparatus. He was getting oxygen and everything else and the patient seemed kind of dazed. The physician told the reporter that the patient was having some breathing difficulties and that the patient's hand had been x-rayed. While receiving breathing treatment when lying flat the patient had inhaled something in his lungs and now the patient had Pneumonia. The patient was breathing alright prior to going to the hospital. The patient also does not have the body strength as he had before. Both arms are weak. His hand were still swollen. Within three days of being admitted to the hospital, the reporter found that the patient had Pneumonia, has no bowel control and can't speak plainly. He was non-responsive and sleeping all of the time. The patient required ER/doctor visit. Laboratory investigations were highest blood sugar has been is 110. X-ray of left hand done on 17 September 2015 for which results were unknown. Corrective treatments were not reported. The event outcome was reported as below: Hand really swollen: Persisting. No strength in either arm: Persisting. No bowel control: Persisting. Can't speak plainly: Persisting. Weak: Persisting. Sleeping all the time: Improved. Non-responsive: Improved. Problems breathing: Improved. Hand hurting: not reported. Seemed dazed: not reported. Inhaled something in his lungs: not reported. Pneumonia: not reported. Documents held by sender: none.
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Peripheral swelling, Pneumonia, Speech disorder, Unresponsive to stimuli, White blood cell count abnormal
Clinical narrative: Initial unsolicited report received from a consumer on 9 October 2015. This case involves an 81-year-old male patient who was vaccinated with an intramuscular dose of FLUZONE (batch number, expiry date not reported) in the right arm and also received a dose of PREVNAR 13 (batch number, expiry date and route of administration not reported, manufacturer Pfizer) in right arm on 11 September 2015 at 12:00 hours. The medical history includes diabetes since 2013, cellulitis in left leg and the patient gets flu shots annually and concomitant medications were not reported. On an unspecified date after the vaccination the patient noticed that his hand was swollen. He was also complaining that his hand was hurting. The patient never complains about anything. He went to the emergency and they slammed him into the hospital, he went to the Urgent Care and they were not able to x-ray his hand to see what was going on with it. So the patient was taken to the emergency. The reporter thought that the patient was admitted in hospital for hand but was surprised to see the patient on breathing apparatus. He was getting oxygen and everything else and the patient seemed kind of dazed. The physician told the reporter that the patient was having some breathing difficulties and that the patient's hand had been x-rayed. While receiving breathing treatment when lying flat the patient had inhaled something in his lungs and now the patient had Pneumonia. The patient was breathing alright prior to going to the hospital. The patient also does not have the body strength as he had before. Both arms are weak. His hand were still swollen. Within three days of being admitted to the hospital, the reporter found that the patient had Pneumonia, has no bowel control and can't speak plainly. He was non-responsive and sleeping all of the time. The patient required ER/doctor visit. Laboratory investigations were highest blood sugar has been is 110. X-ray of left hand done on 17 September 2015 for which results were unknown. Corrective treatments were not reported. The event outcome was reported as below: Hand really swollen: Persisting. No strength in either arm: Persisting. No bowel control: Persisting. Can't speak plainly: Persisting. Weak: Persisting. Sleeping all the time: Improved. Non-responsive: Improved. Problems breathing: Improved. Hand hurting: not reported. Seemed dazed: not reported. Inhaled something in his lungs: not reported. Pneumonia: not reported. Documents held by sender: none.
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: X-ray limb
Clinical narrative: Initial unsolicited report received from a consumer on 9 October 2015. This case involves an 81-year-old male patient who was vaccinated with an intramuscular dose of FLUZONE (batch number, expiry date not reported) in the right arm and also received a dose of PREVNAR 13 (batch number, expiry date and route of administration not reported, manufacturer Pfizer) in right arm on 11 September 2015 at 12:00 hours. The medical history includes diabetes since 2013, cellulitis in left leg and the patient gets flu shots annually and concomitant medications were not reported. On an unspecified date after the vaccination the patient noticed that his hand was swollen. He was also complaining that his hand was hurting. The patient never complains about anything. He went to the emergency and they slammed him into the hospital, he went to the Urgent Care and they were not able to x-ray his hand to see what was going on with it. So the patient was taken to the emergency. The reporter thought that the patient was admitted in hospital for hand but was surprised to see the patient on breathing apparatus. He was getting oxygen and everything else and the patient seemed kind of dazed. The physician told the reporter that the patient was having some breathing difficulties and that the patient's hand had been x-rayed. While receiving breathing treatment when lying flat the patient had inhaled something in his lungs and now the patient had Pneumonia. The patient was breathing alright prior to going to the hospital. The patient also does not have the body strength as he had before. Both arms are weak. His hand were still swollen. Within three days of being admitted to the hospital, the reporter found that the patient had Pneumonia, has no bowel control and can't speak plainly. He was non-responsive and sleeping all of the time. The patient required ER/doctor visit. Laboratory investigations were highest blood sugar has been is 110. X-ray of left hand done on 17 September 2015 for which results were unknown. Corrective treatments were not reported. The event outcome was reported as below: Hand really swollen: Persisting. No strength in either arm: Persisting. No bowel control: Persisting. Can't speak plainly: Persisting. Weak: Persisting. Sleeping all the time: Improved. Non-responsive: Improved. Problems breathing: Improved. Hand hurting: not reported. Seemed dazed: not reported. Inhaled something in his lungs: not reported. Pneumonia: not reported. Documents held by sender: none.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Head injury, Loss of consciousness
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 24-year-old female patient. The patient medical history and concurrent condition were not reported. The patient was not pregnant and had no history of drug reaction or allergies. On 19-OCT-2015, the patient was vaccinated with first dose in the series of GARDASIL 9 (0.5ml, lot # L007495 exp date 24-FEB-2017) intramuscular. No concomitant medications. On 19-OCT-2015, Approximately 5 minutes after administration, the patient attempted to get up while unattended and fell. The primary reporter stated that the patient hit her head and face, was unconscious with multiple lacerations. The primary reporter stated that the patient sought medical attention and left the office via ambulance for hospital emergency room. The primary reporter stated that on the patient's right and left side of forehead were V shaped 2cm lacerations, on the bridge of her nose a 5 cm laceration, and above her top lip at 5 cm laceration. The primary reporter stated that the patient was conscious when she left for the hospital. The outcome of the reported events was unknown. The reporter did not provide the causality between the events and the suspect therapy. Upon internal review, the event unconscious was determined to be medically significant. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Face injury, Fall, Head injury, Laceration, Lip injury
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 24-year-old female patient. The patient medical history and concurrent condition were not reported. The patient was not pregnant and had no history of drug reaction or allergies. On 19-OCT-2015, the patient was vaccinated with first dose in the series of GARDASIL 9 (0.5ml, lot # L007495 exp date 24-FEB-2017) intramuscular. No concomitant medications. On 19-OCT-2015, Approximately 5 minutes after administration, the patient attempted to get up while unattended and fell. The primary reporter stated that the patient hit her head and face, was unconscious with multiple lacerations. The primary reporter stated that the patient sought medical attention and left the office via ambulance for hospital emergency room. The primary reporter stated that on the patient's right and left side of forehead were V shaped 2cm lacerations, on the bridge of her nose a 5 cm laceration, and above her top lip at 5 cm laceration. The primary reporter stated that the patient was conscious when she left for the hospital. The outcome of the reported events was unknown. The reporter did not provide the causality between the events and the suspect therapy. Upon internal review, the event unconscious was determined to be medically significant. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 24-year-old female patient. The patient medical history and concurrent condition were not reported. The patient was not pregnant and had no history of drug reaction or allergies. On 19-OCT-2015, the patient was vaccinated with first dose in the series of GARDASIL 9 (0.5ml, lot # L007495 exp date 24-FEB-2017) intramuscular. No concomitant medications. On 19-OCT-2015, Approximately 5 minutes after administration, the patient attempted to get up while unattended and fell. The primary reporter stated that the patient hit her head and face, was unconscious with multiple lacerations. The primary reporter stated that the patient sought medical attention and left the office via ambulance for hospital emergency room. The primary reporter stated that on the patient's right and left side of forehead were V shaped 2cm lacerations, on the bridge of her nose a 5 cm laceration, and above her top lip at 5 cm laceration. The primary reporter stated that the patient was conscious when she left for the hospital. The outcome of the reported events was unknown. The reporter did not provide the causality between the events and the suspect therapy. Upon internal review, the event unconscious was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist technician via company representative refers to a patient of unknown age and gender. Concurrent or medical conditions were not reported. The pharmacist technician reported that an expired ZOSTAVAX (dose, strength, frequency and lot number were not reported), was administered to a unspecified patient. No product quality complain was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist technician via company representative refers to a patient of unknown age and gender. Concurrent or medical conditions were not reported. The pharmacist technician reported that an expired ZOSTAVAX (dose, strength, frequency and lot number were not reported), was administered to a unspecified patient. No product quality complain was reported. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Pharyngeal oedema, Tachycardia
Clinical narrative: Throat swelled, difficulty breathing, tachycardia, Took an allergy pill.  Problem continued for 6 hours.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Back pain, Diarrhoea, Flank pain, Herpes zoster
Clinical narrative: Diarrhea, upset stomach, extreme stabbing pain on left side and pain on back, sensitive skin (burning sensation) from left waist to back, then on 10/10/15, visible rash appeared on front. Then spread over days to back. Shingles diagnosed by doctor on 10/10/15.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Skin burning sensation
Clinical narrative: Diarrhea, upset stomach, extreme stabbing pain on left side and pain on back, sensitive skin (burning sensation) from left waist to back, then on 10/10/15, visible rash appeared on front. Then spread over days to back. Shingles diagnosed by doctor on 10/10/15.
Age: 30.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Malaise
Clinical narrative: Malaise & diarrhea for 48 hours.
Age: 8.0
Sex: F
Vaccine: RAB
Symptoms: Peripheral swelling, Rash
Clinical narrative: Child had a reaction after getting a Rabies shot in ER. Reaction started 2 minutes after shots given. Benadryl given. Symptoms-swollen feet, legs and slight rash. Symptoms subsided 1 hour after Benadryl taken.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Hypoaesthesia, Lumbar puncture, Muscular weakness, Nerve conduction studies
Clinical narrative: Numbness and tingling - pain - weakness in legs and arms starting app. 12-1-12. Extensive blood tests, nerve conduction study, spinal taps. Treatment consist of pain meds and physical therapy.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paraesthesia
Clinical narrative: Numbness and tingling - pain - weakness in legs and arms starting app. 12-1-12. Extensive blood tests, nerve conduction study, spinal taps. Treatment consist of pain meds and physical therapy.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Immunoglobulin therapy, Peripheral swelling, Rash
Clinical narrative: Client stated she had a reaction after getting a Rabies shot in ER. Reaction started 2 minutes after shots given. Benadryl given. Symptoms-swollen feet, legs and slight rash. Symptoms subsided 1 hour after Benadryl taken. Client and her 4 children also received Gamma globulin.
Age: 14.0
Sex: F
Vaccine: FLUX
Symptoms: Ear swelling, Eye swelling, Lethargy, Lip swelling, Pain
Clinical narrative: Swelling of eyes, cheeks, lips, and left ear after 24 hours. Within 48 hours body aches and pain with severe lethargy.
Age: 14.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling face
Clinical narrative: Swelling of eyes, cheeks, lips, and left ear after 24 hours. Within 48 hours body aches and pain with severe lethargy.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Blood potassium, Chills, Dizziness, Haemoglobin
Clinical narrative: Patient received a quad flu shot at a pharmacy, within minutes became weak and dizzy, followed with nausea and lip tingling, also tongue numbness, feeling of passing out. Pt drove herself and 8 month old baby to an ER who would not listen any information related to the shot she just received, she was given 2 XANAX and sent home. The patient became sicker with a high fever and nausea vomiting and chills, all of her skin hurt. The pharmacy was made aware of the problem. She also had a hive at the injection site. She was put into a room with her baby and the door to the room shut, alone.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia oral, Injection site urticaria, Nausea, Pain of skin, Paraesthesia oral
Clinical narrative: Patient received a quad flu shot at a pharmacy, within minutes became weak and dizzy, followed with nausea and lip tingling, also tongue numbness, feeling of passing out. Pt drove herself and 8 month old baby to an ER who would not listen any information related to the shot she just received, she was given 2 XANAX and sent home. The patient became sicker with a high fever and nausea vomiting and chills, all of her skin hurt. The pharmacy was made aware of the problem. She also had a hive at the injection site. She was put into a room with her baby and the door to the room shut, alone.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient received a quad flu shot at a pharmacy, within minutes became weak and dizzy, followed with nausea and lip tingling, also tongue numbness, feeling of passing out. Pt drove herself and 8 month old baby to an ER who would not listen any information related to the shot she just received, she was given 2 XANAX and sent home. The patient became sicker with a high fever and nausea vomiting and chills, all of her skin hurt. The pharmacy was made aware of the problem. She also had a hive at the injection site. She was put into a room with her baby and the door to the room shut, alone.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Patient reacted to vaccine with red, itchy swollen area on arm.  Approximately 2 inches in diameter in center of larger paler red spot approximately 4x6" oval area.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Rash, Urticaria
Clinical narrative: Rash on hands, welt on arm extending from shoulder to elbow. Aching joints and tiredness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Joint swelling, Peripheral swelling, Rash
Clinical narrative: Developed rash/swelling to lower extremities and buttocks, gait problem, joint swelling.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Patient stated "I got dizzy one hour after I got the flu shot." Dizzy enough that I felt I shouldn't drive. That lasted approx. 10 hours. I also experienced a numbness in my arm, which has gone away except for a little numbness in the tip of my thumb.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: Headache, fever, malaise, fatigue.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Amnesia, Blood creatine phosphokinase, Blood iron, Cardiac function test, Cardiac telemetry
Clinical narrative: Muscle tremors, Loss of motor function, Loss of Appetite, Dry mouth, Fever, Blurred vision, Incontinence, Disoriented, Headache, Memory Loss.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Computerised tomogram, Decreased appetite, Disorientation, Dry mouth, Electrocardiogram
Clinical narrative: Muscle tremors, Loss of motor function, Loss of Appetite, Dry mouth, Fever, Blurred vision, Incontinence, Disoriented, Headache, Memory Loss.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Full blood count, Headache, Incontinence, Iron binding capacity total, Liver function test
Clinical narrative: Muscle tremors, Loss of motor function, Loss of Appetite, Dry mouth, Fever, Blurred vision, Incontinence, Disoriented, Headache, Memory Loss.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Metabolic function test, Motor dysfunction, Neurological examination, Pyrexia, Tremor
Clinical narrative: Muscle tremors, Loss of motor function, Loss of Appetite, Dry mouth, Fever, Blurred vision, Incontinence, Disoriented, Headache, Memory Loss.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Urine analysis, Vision blurred, Vitamin B12
Clinical narrative: Muscle tremors, Loss of motor function, Loss of Appetite, Dry mouth, Fever, Blurred vision, Incontinence, Disoriented, Headache, Memory Loss.
Age: 9.0
Sex: M
Vaccine: FLUN4, HEPA
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Redness, itching and rash over the Hep A#2 injection site given 2 days ago at his wcc.   Mom stated that the shot bothered him later that same day and the next day it started feelin itchy and "bumpy".  Mom applied HC cream and gave Benadryl but when he woke up this am, the site was more red and a little worse compared to yesterday.   It is painless.   It is mildly pruritic now but was more yesterday.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Joint range of motion decreased, Pain
Clinical narrative: Patient states she has pain, limited range of motion an difficulty sleeping since receiving the vaccine. Patient going to doctor today wanting reimbursement for appointment and tests.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Upper extremity mass
Clinical narrative: Hard lump by lower biceps reported by patient. Pt obtaining MRI per pt 10/22/15.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count normal, Injection site reaction, Local reaction, Malaise, Paraesthesia
Clinical narrative: HIGH DOSE FLUZONE administered by pharmacist on 10-19-15 at 7:00 pm. Developed localized reaction at site within one hour which increased in size and then had some paresthesia in left hand and had malaise when seen on 10-20-15. Had improved by 10-21-15 when phone call to patient.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: HIGH DOSE FLUZONE administered by pharmacist on 10-19-15 at 7:00 pm. Developed localized reaction at site within one hour which increased in size and then had some paresthesia in left hand and had malaise when seen on 10-20-15. Had improved by 10-21-15 when phone call to patient.
Age: 0.9
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (R) leg red swollen.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Hyperhidrosis, Injection site swelling, Lymphadenopathy
Clinical narrative: Fever chills, severe headache. Body aches sweats swollen neck glands. Swelling at injection site.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: Fever chills, severe headache. Body aches sweats swollen neck glands. Swelling at injection site.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site of injection, denies pain or itching.
Age: 1.53
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Abnormal behaviour, Diarrhoea, Head injury, Pyrexia, Screaming
Clinical narrative: Fever as high as 105, seizures, high pitched screaming, vomiting, diarrhea, hitting himself in head, scratching at his face/skin, pulling his hair out by the handfuls, will not let anyone touch him.
Age: 1.53
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Seizure, Trichotillomania, Vomiting
Clinical narrative: Fever as high as 105, seizures, high pitched screaming, vomiting, diarrhea, hitting himself in head, scratching at his face/skin, pulling his hair out by the handfuls, will not let anyone touch him.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Large area erythema arm lasting 4 days.
Age: 1.13
Sex: M
Vaccine: FLU4
Symptoms: Crying, Diarrhoea, Pyrexia, Screaming, Vomiting
Clinical narrative: Fever of 102, vomiting, diarrhea, high pitched screaming/crying.
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Disorientation, Laboratory test normal, Road traffic accident
Clinical narrative: CAR ACCIDENT DUE TO DISORIENTATION OF THE PATIENT.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and soreness at injection site.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Patient is a home care patient through our public health agency and one of our home care nurses assigned to this patient administered a flu vaccine on 10/9/2015 at this patients home.  It was reported to the immunization nurse  on Thursday October 22, 2015 that patient was in a Burn unit with Steven Johnson Syndrome.  Nurse reported patient had Steven Johnson Syndrome a long time ago, but the doctor's may have felt the flu vaccine could have contributed.  Patient take antipsychotics and antiepileptics daily.
Age: 0.9
Sex: M
Vaccine: PNC13
Symptoms: Cough, Crying, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: FEVER, VOMITING, DIARRHEA, COUGHING, INCREASED CRYING.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Injection site erythema, Injection site swelling, Pharyngeal oedema
Clinical narrative: Swelling in throat, difficulty swallowing. Redness and swellilng at injection site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swelling (6x5.5 inches), redness, warm to touch with pain.  She was given Diphenhydramine 25mg 1-2 tablets every 6 hours as needed, Tylenol for pain and told to use ice intermittently for the swelling.
Age: 1.31
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness with slight swelling on the anterior left thigh, 10x5 cm. No induration. Denies any fever or administration of medications. Mother instructed by provider to apply cold compresses.
Age: 69.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Face injury, Loss of consciousness
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a currently 69 year old male patient. The patient's concurrent condition and medical history were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 injection, lot # L003188, expiration date 06-JUN-2016 (dose and route of administration were not reported). On the same day, the patient also received an unspecified Flu vaccine. Concomitant therapies included hydrochlorothiazide, trazodone hydrochloride and insulin. The reported stated, that on an unknown date the patient passed out and hit his face after receiving PNEUMOVAX 23. It was reported, that the patient was taken by ambulance to hospital. They kept him overnight for observation and they did not find anything to be wrong with him (also reported as the patient was not admitted). The patient recovered from the event: passed out and the outcome of the event: hit his head was not reported. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Condition aggravated, Injected limb mobility decreased, Injection site pain, Osteoarthritis
Clinical narrative: This is a spontaneous report obtained from a contactable nurse. This nurse reported for four patients, this is the second of fourth reports. A 90-year-old female patient received PREVNAR 13 (Lot. L99275; Expiration date: 31Mar2017, NDC number: 005-1971-02) on 08Oct2015 at 15:00, intramuscularly in left arm, at 0.5 ml, single dose and the eighth dose of FLUZONE (Lot. UI456AA, Expiration date: 19Apr2016, NDC number: 49281-397-65, manufacturer: Sanofi Pasteur) on 08Oct2015, intramuscularly in right arm, at 1 DF, single dose. No illness was noted at time of vaccination. The vaccines was administered at the private doctor's office and was purchased with public funds. Relevant medical history included degenerative joint disease (ongoing) and diabetes (ongoing). The patient received, on an unspecified date, seven previous doses of influenza vaccine. Concomitant medications were unknown. The patient received the vaccinations on 08Oct2015 and within 2-3 hours experienced severe left deltoid pain and couldn't move her arm. Emergency room visit was required. Patient went to the hospital because she couldn't move her arm (hospitalization start date: 08Oct2015, hospitalization end date: 12Oct2015). Diagnosis was degenerative joint disease and that the immunization triggered an underlying syndrome she may have had. Clinical outcome of the events was unknown at time of this report. Nurse thought it was somewhat related to vaccination.
Age: 90.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Condition aggravated, Injected limb mobility decreased, Injection site pain, Osteoarthritis, Pain in extremity
Clinical narrative: This is a spontaneous report obtained from a contactable nurse. This nurse reported for four patients, this is the second of fourth reports. A 90-year-old female patient received PREVNAR 13 (Lot. L99275; Expiration date: 31Mar2017, NDC number: 005-1971-02) on 08Oct2015 at 15:00, intramuscularly in left arm, at 0.5 ml, single dose and the eighth dose of FLUZONE (Lot. UI456AA, Expiration date: 19Apr2016, NDC number: 49281-397-65, manufacturer: Sanofi Pasteur) on 08Oct2015, intramuscularly in right arm, at 1 DF, single dose. No illness was noted at time of vaccination. The vaccines was administered at the private doctor's office and was purchased with public funds. Relevant medical history included degenerative joint disease (ongoing) and diabetes (ongoing). The patient received, on an unspecified date, seven previous doses of influenza vaccine. Concomitant medications were unknown. The patient received the vaccinations on 08Oct2015 and within 2-3 hours experienced severe left deltoid pain and couldn't move her arm. Emergency room visit was required. Patient went to the hospital because she couldn't move her arm (hospitalization start date: 08Oct2015, hospitalization end date: 12Oct2015). Diagnosis was degenerative joint disease and that the immunization triggered an underlying syndrome she may have had. Clinical outcome of the events was unknown at time of this report. Nurse thought it was somewhat related to vaccination.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: C-reactive protein, Cellulitis, Erythema, Full blood count, Mobility decreased
Clinical narrative: Initial unsolicited report received from non-healthcare professional on 13-Oct-2015. This case involves a 58-year-old female patient who was vaccinated with an intramuscular dose of ADACEL (batch number- U5278AA, expiry date- 25-Feb-2018 route and site of administration were not reported) on 02-Oct-15. It was reported that patient had scratched her leg on rusty nail on the day of vaccine administration. Patient had medical history of Arthritis, GERD, Hypothyroidism and Sleep Apnea and concomitant medications were not reported. On 06-Oct-15, four days after vaccination, patient had experienced redness, swelling, having difficulty raising arm, weakness of the arm which Physician had considered as cellulitis. Patient required ER/doctor visit. Lab tests included CBC, CRP which were being ordered today (at the time of report). Patient was placed on antibiotics as corrective treatment. Outcome of the event was reported as unknown. Upon medical review, the case was considered as serious due to important medical event: cellulitis. Documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Swelling
Clinical narrative: Initial unsolicited report received from non-healthcare professional on 13-Oct-2015. This case involves a 58-year-old female patient who was vaccinated with an intramuscular dose of ADACEL (batch number- U5278AA, expiry date- 25-Feb-2018 route and site of administration were not reported) on 02-Oct-15. It was reported that patient had scratched her leg on rusty nail on the day of vaccine administration. Patient had medical history of Arthritis, GERD, Hypothyroidism and Sleep Apnea and concomitant medications were not reported. On 06-Oct-15, four days after vaccination, patient had experienced redness, swelling, having difficulty raising arm, weakness of the arm which Physician had considered as cellulitis. Patient required ER/doctor visit. Lab tests included CBC, CRP which were being ordered today (at the time of report). Patient was placed on antibiotics as corrective treatment. Outcome of the event was reported as unknown. Upon medical review, the case was considered as serious due to important medical event: cellulitis. Documents held by sender: none.
Sex: U
Vaccine: HPV4, MNQ
Symptoms: Burning sensation, Dyspnoea, Monoplegia, Sensory loss, Tinnitus
Clinical narrative: Initial unsolicited report received from a pharmacist on 15 October 2015. This case is linked with case 2015SA164326 (same events and different patients). This case involves three patients (age and gender not reported) those were vaccinated with a dose of MENACTRA and a dose of GARDASIL (manufacturer other) (batch number, dose, route and site of administration was not reported for both vaccines) on an unspecified date last month. All patients' medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, all patients experienced lower leg paralysis, decreased sensation below knees, felt a burning sensation all over body, had air hunger, O2 WNL (within normal limits) and tinnitus. Lab data and corrective treatments were not reported. Outcome of events was unknown. Upon internal review, the company decided to consider the case serious because of important medical event: lower leg paralysis and decreased sensation below knees. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and pruritus (R) upper arm from shoulder to elbow.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: I gave a full dose flu vaccine age 3 and up (0.5 ml) to a 2 year old child (child weight 36.4 lbs). This has been reported to parent and my supervisor.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Blood pressure increased, Chest X-ray normal, Dizziness, Hyperhidrosis
Clinical narrative: Weakness, diaphoretic, light headed, nausea. Elevated blood pressure, all else normal. Symptoms lasted about 4 hrs. with gradual improvement. Normal at discharge with B/P still elevated.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test normal, Nausea
Clinical narrative: Weakness, diaphoretic, light headed, nausea. Elevated blood pressure, all else normal. Symptoms lasted about 4 hrs. with gradual improvement. Normal at discharge with B/P still elevated.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Fatigue, Viral infection
Clinical narrative: Viral sx, fatigue, chest discomfort.
Age: 7.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Body temperature increased, Injection site erythema
Clinical narrative: Rednes at flu vaccine site (left deltoid) 102 degrees F temperature.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Chest X-ray abnormal, Cough, Hypoaesthesia, Paraesthesia
Clinical narrative: Seen on 10/14/15 - Was seen 10/13/15 for left wrist pain with numbness and tingling in hand/fingers (of note played soccer on 101215 and had several falls). Had fever when seen on 10/14/15 by us also cough/congestion - seen 10/15/14 again by ortho for wrist pain.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Seen on 10/14/15 - Was seen 10/13/15 for left wrist pain with numbness and tingling in hand/fingers (of note played soccer on 101215 and had several falls). Had fever when seen on 10/14/15 by us also cough/congestion - seen 10/15/14 again by ortho for wrist pain.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Blood chloride normal, Blood creatinine normal, Blood magnesium normal, Blood potassium normal, Blood sodium normal
Clinical narrative: The patent describes heavy sweating, body aches, fever, and sore throat, plus 1 day of chest pain earlier in the week.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Blood thyroid stimulating hormone normal, Blood urea normal, Carbon dioxide normal, Chest pain, Hyperhidrosis
Clinical narrative: The patent describes heavy sweating, body aches, fever, and sore throat, plus 1 day of chest pain earlier in the week.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: The patent describes heavy sweating, body aches, fever, and sore throat, plus 1 day of chest pain earlier in the week.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Arthralgia, Eyelid oedema, Eyelid pain, Oedema, Pain
Clinical narrative: Flu vaccine and Tdap administered day 1 9/29/2015. Day 2 - body aches and low grade fever - Tmax 99.2 also eye lid pain. Day 3 - woke up - puffy, red and painful eye lids, continued body aches and low grade fever through Day 6. Approximately Day 5, red raised macule-papular and painful rash to upper chest, upper back, bilateral arms and legs. This lasted through Day 11. Joint pain and edema began approx day 10 and continued currently.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: Flu vaccine and Tdap administered day 1 9/29/2015. Day 2 - body aches and low grade fever - Tmax 99.2 also eye lid pain. Day 3 - woke up - puffy, red and painful eye lids, continued body aches and low grade fever through Day 6. Approximately Day 5, red raised macule-papular and painful rash to upper chest, upper back, bilateral arms and legs. This lasted through Day 11. Joint pain and edema began approx day 10 and continued currently.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain, Sleep disorder
Clinical narrative: Patient complain of a bruised back. She cannot lift anything heavy and above the waist. Cannot sleep on left side. Had to take meloxicam for pain.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Myocardial infarction
Clinical narrative: Not feeling well evening after shot given. Went to ER via ambulance, possible heart attack.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Swollen, red, large area (L) arm, shoulder, itchy it spread almost around whole arm, it was hot painful.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Pharyngeal oedema, Pyrexia
Clinical narrative: Fever, swollen throat, "green stuff coming out of eyes: starting 4h after shot and resolving the next morning.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Induration, Tenderness, Urticaria
Clinical narrative: Hive like rash with central induration tenderness. Treated with antihistamines and KEFLEX.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Rash erythematous, Skin warm
Clinical narrative: Red hot rash and pain in joints down left side. Lasted 3-4 days and resolved on its own.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Limb discomfort, Muscle strain, Pain in extremity, Paraesthesia
Clinical narrative: Developed heaviness (L) upper arm 1 hour after vaccine administration . Heaviness spread to hand and persisted. On 10/19/15 she pulled a neck muscle doing yoga and arm became tingly numb and painful. R/R PCP 10/12/15 given ibuprofen.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Abasia, Aphasia, Injection site discolouration, Malaise, Nausea
Clinical narrative: Unable to walk or talk x 4 days. Arm swelled and injection site turned black. Nausea and did not feel well.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: Unable to walk or talk x 4 days. Arm swelled and injection site turned black. Nausea and did not feel well.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Pain, Palpitations
Clinical narrative: Started with chills, fever of 102.5, fatigue, headache, shaking, vomiting at 9:15 PM. Heart rate 95 and felt like heart was beating out of my chest. No chest pain or difficulty breathing. Took 1 Aleve at 11:30. At 12:30 am fever decreased to 101.5. General aches. Fever 101.5 at 4:00 am. Now at 11:15 am fever is 99.6. Feeling better but general fatigue and mild headache remains.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: Started with chills, fever of 102.5, fatigue, headache, shaking, vomiting at 9:15 PM. Heart rate 95 and felt like heart was beating out of my chest. No chest pain or difficulty breathing. Took 1 Aleve at 11:30. At 12:30 am fever decreased to 101.5. General aches. Fever 101.5 at 4:00 am. Now at 11:15 am fever is 99.6. Feeling better but general fatigue and mild headache remains.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Mobility decreased, Pain in extremity
Clinical narrative: Could not lift arm that night, tried to keep moving it, iced it, seemed to worsen, hot water bottle, ADVIL. helped, very sore for about 3 days, hardly could move it. Told nurse on 9/21/15. Use BIO FREEZE and wraps for work days. 10-14-15 finally felt better. Started physical therapy (work) 10-13-15 electrode pads, achiness is better. As of 10017-15 not 100% very 95% better. Shot was given high on right arm - higher than in previous years.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness, Paralysis
Clinical narrative: According to school nurse, patient experienced paralysis and blindness. Unknown if attributed to possible viral illness patient had.
Age: 11.0
Sex: F
Vaccine: HPV2
Symptoms: Rash generalised
Clinical narrative: Mother of the girl stated that after the second dose of the HPV vaccine the girl developed a rash through her whole body.
Age: 66.0
Sex: F
Vaccine: PNC13, TD
Symptoms: Injection site erythema
Clinical narrative: Injection area red with no increased warmth or tenderness. Over the counter steroid cream recommended.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at injection site.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Neck pain
Clinical narrative: Patient stated he had pain radiating up his back and neck. He also stated he moved a significant amount of weight/load at work the previous day.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Pain
Clinical narrative: Nerve type pain when making sudden arm movements especially reaching back behind. Has persisted for approximately 3 weeks now and is still on going.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, HEPA, RV5
Symptoms: Wrong drug administered
Clinical narrative: Provider ordered 12 month shots and one of the vaccination names was Vaqta and MA's and vaccination providers both stated they thought the order said "Rotataq", 2 person check policy is in place for vaccinations but did not occur correctly and incident report will be sent to corporate company and also discussed internally and changes to be made to avoid this error in future.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Muscular weakness, Ultrasound biliary tract, Vomiting
Clinical narrative: Very severe stomach pains, vomiting weakness in legs went on all day went to hospital said maybe virus, went to dr, was sent to have gall bladder check.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test normal, Influenza virus test negative, Peripheral swelling, Rash generalised
Clinical narrative: Rash on body. Swollen hands.
Age: 60.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Headache, Pyrexia
Clinical narrative: Patient ran fever of 100.5 degrees F that night after receiving FLUARIX and PNEUMOVAX 23 vaccines earlier that morning. Patient also reported a headache that night. Both headache and fever resolved the following morning.
Age: 52.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: 10-17/15- Arm is sore, red inflamed, hot to the touch area about 2 inches below site of shot. 10/1815 - Area is still sore, red and inflamed.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Pharyngeal oedema
Clinical narrative: Anaphylaxis approximately 4 hrs after immunization (throat swelling, difficulty breathing).
Age: 85.0
Sex: F
Vaccine: FLUC3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Muscle soreness, red, hot, itchy, mild swelling at site of PREVNAR vaccination. Patient advised to ice and take diphenhydramine 25mg po at bedtime and up to event 6 hours during the day if able.
Age: 85.0
Sex: F
Vaccine: FLUC3, PNC13
Symptoms: Myalgia
Clinical narrative: Muscle soreness, red, hot, itchy, mild swelling at site of PREVNAR vaccination. Patient advised to ice and take diphenhydramine 25mg po at bedtime and up to event 6 hours during the day if able.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Pain in extremity, Skin warm, Upper extremity mass
Clinical narrative: (L) arm marble size lump with baseball sized redness no fever but area painful. To use BENADRYL OTC be seen if area gets larger or fever, area hot but no fever documented.
Age: 82.0
Sex: U
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Pyrexia
Clinical narrative: Chills, fever 102 degrees, felt like couldn't breathe, lasted 5 hours, no rash, felt like gasping for air couple of hours.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Malaise, Pain, Pyrexia, Wrong drug administered
Clinical narrative: Patient received a FLUZONE HD instead of FLUARIX PFS Qud. Had low grade fever, malaise and head/body ache.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Sensation of foreign body
Clinical narrative: About 3 hours post injection, patient developed anaphylactic reaction. She had difficulty swallowing and felt lump in throat that progressed to difficulty breathing. Patient called ambulance and was given 50mg BENADRYL IM and oxygen. At emergency department, patient received further BENADRYL and steroids, which resolved symptoms. Unable to receive epinephrine due to allergy.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Full blood count normal, Hepatitis C antibody negative, Hepatitis viral test negative, Metabolic function test normal, Rash
Clinical narrative: 10/8/15 - Influenza vaccine administered. 10/9/15 or 10/10/15 - skin rash developed on legs and began traveling upward to abdomen/arms over next several days. 10/15/15 patient reported symptoms. Seen by Dr. Dx'd with vasculitis, tx'd with prednisone.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Vasculitis
Clinical narrative: 10/8/15 - Influenza vaccine administered. 10/9/15 or 10/10/15 - skin rash developed on legs and began traveling upward to abdomen/arms over next several days. 10/15/15 patient reported symptoms. Seen by Dr. Dx'd with vasculitis, tx'd with prednisone.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose increased, Pyrexia
Clinical narrative: FEVER AND ELEVATED BLOOD GLUCOSE READINGS. 488 THAT NIGHT, 308 THE NEXT MORNING AND IN THE 200'S TODAY. I TOLD HER TO CONTACT HER DR. I CALLED MD'S OFFICE AND THEY SAID THEY WOULD CALL BACK.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain
Clinical narrative: Patient noticed pain 10/15/15-10/20/15, Then redness at the injection site on 10/20/15 about 1-2" in diameter. Pt was advised to take Benadryl+ibuprofen, and if no improvement, see her MD. The redness continued and covered most of her upper arm. She saw her MD the next day and was diagnosed as an allergic reaction and not a secondary infection.
Age: 21.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Around 24 hours after the vaccine was administered, my right upper arm became red, swollen and warm to the touch.