chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Intensive care, Mechanical ventilation, Myasthenia gravis, Nuclear magnetic resonance imaging, Respiratory distress
Clinical narrative: On 10/20/15, I visited my family physician, who prescribed some medications for my sinus and respiratory distress. On 11/6/15, I visited my Cardiologist, who confirmed I did not have a heart issue. On 11/7/15, I again went to Hospital, because I swallowed a large pill that got caught in my throat and went into my lung. I was now having difficulty swallowing and beginning to lose weight. Fortunately, I was able to cough up the pill. On 11/10 and 11/15, I went to my Pulmonologist for an X-rays of my Lungs and then a reading of the X-rays. The Pulmonologist said my lungs were not the cause of the breathing difficulty. He also suggested that I continue the sinus medications and visit an ENT doctor. The first available appointment for my ENT was December 12, 2015. During the time between this appointment and the ENT appointment, my ability to swallow decreased dramatically. I had to cut food smaller and smaller and eventually, I could only eat cereals like Cream of Wheat. On 12/11/2015, I went to an ENT doctor, and after an extensive office visit, he recommended that I see a neurologist as soon as possible. On 12/12/2015, I was in severe respiratory distress and my daughter took me to Hospital for evaluation and testing because of my persistent sinus issue and respiratory distress. Some of the evaluation tests completed at Hospital included an MRl, CT scan, and an Endoscopy, various blood tests plus others. I was told by various doctors at Hospital that perhaps I had a sinus infection, or a severe allergic reaction to one of my long term blood pressure medications or a DVT among other possibilities. I was admitted to hospital and moved from the ER to an observation room to continue my medical evaluation. However, my condition continued to deteriorate and on December 16, I was transferred to an ICU room at Hospital and placed on a ventilator with a suspected diagnosis of Myasthenia Gravis. On 12/18/2015, I was transferred to another hospital to a Neurological ICU for further examination. During my time there I underwent several tests to rule out different diagnostics. On 12/28/2015, because of continued respiratory distress and difficulty swallowing I received a Tracheostomy, a PEG tube and IVIG infusions (over several days) while in the ICU. On 1/4/2016, the results of a blood test taken at another Hospital confirmed the originally suspected diagnosis of Myasthenia Gravis. On 1/6/2016, I was transferred by ambulance to rehab because I needed oxygen, suctioning for my Trach, training on how to use my feeding tube, and rehabilitation to help me relearn how to walk and talk again. On 1/28/2016, I was released from Rehab to continue my rehabilitation at home using the service of Rehab's home health care services. These services were specifically for physical, speech and occupational therapy as well as the services of a visiting nurse. These services lasted approximately 6 to 8 week depending on my progress on each service. Speech therapy took the longest.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Sinus disorder, Speech disorder, Tracheostomy
Clinical narrative: On 10/20/15, I visited my family physician, who prescribed some medications for my sinus and respiratory distress. On 11/6/15, I visited my Cardiologist, who confirmed I did not have a heart issue. On 11/7/15, I again went to Hospital, because I swallowed a large pill that got caught in my throat and went into my lung. I was now having difficulty swallowing and beginning to lose weight. Fortunately, I was able to cough up the pill. On 11/10 and 11/15, I went to my Pulmonologist for an X-rays of my Lungs and then a reading of the X-rays. The Pulmonologist said my lungs were not the cause of the breathing difficulty. He also suggested that I continue the sinus medications and visit an ENT doctor. The first available appointment for my ENT was December 12, 2015. During the time between this appointment and the ENT appointment, my ability to swallow decreased dramatically. I had to cut food smaller and smaller and eventually, I could only eat cereals like Cream of Wheat. On 12/11/2015, I went to an ENT doctor, and after an extensive office visit, he recommended that I see a neurologist as soon as possible. On 12/12/2015, I was in severe respiratory distress and my daughter took me to Hospital for evaluation and testing because of my persistent sinus issue and respiratory distress. Some of the evaluation tests completed at Hospital included an MRl, CT scan, and an Endoscopy, various blood tests plus others. I was told by various doctors at Hospital that perhaps I had a sinus infection, or a severe allergic reaction to one of my long term blood pressure medications or a DVT among other possibilities. I was admitted to hospital and moved from the ER to an observation room to continue my medical evaluation. However, my condition continued to deteriorate and on December 16, I was transferred to an ICU room at Hospital and placed on a ventilator with a suspected diagnosis of Myasthenia Gravis. On 12/18/2015, I was transferred to another hospital to a Neurological ICU for further examination. During my time there I underwent several tests to rule out different diagnostics. On 12/28/2015, because of continued respiratory distress and difficulty swallowing I received a Tracheostomy, a PEG tube and IVIG infusions (over several days) while in the ICU. On 1/4/2016, the results of a blood test taken at another Hospital confirmed the originally suspected diagnosis of Myasthenia Gravis. On 1/6/2016, I was transferred by ambulance to rehab because I needed oxygen, suctioning for my Trach, training on how to use my feeding tube, and rehabilitation to help me relearn how to walk and talk again. On 1/28/2016, I was released from Rehab to continue my rehabilitation at home using the service of Rehab's home health care services. These services were specifically for physical, speech and occupational therapy as well as the services of a visiting nurse. These services lasted approximately 6 to 8 week depending on my progress on each service. Speech therapy took the longest.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site inflammation, Injection site pain, Thrombosis
Clinical narrative: Pt's father just noted patient had a lot of pain and inflammation from injection that got progressively worse...she finally went into urgent care this AM and Dr. found a blood clot.  When I asked more about the issue, pt's father just said he figured we would want to know.  I attempted to reach out to pt but have not received a call back yet.
Age: 78.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth at injection site.  The area of redness is 4" in diameter.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Pt had itching and rash. No SOB or swollen tongue. No breathing distress. Pt took benadryl at 6pm on 11-12-16. She continued benadryl thru the night every 6 hours. Pt also applied cool washrags to reduce itching.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Myalgia, Pain in extremity
Clinical narrative: Swelling, redness and itching at the site of injection and muscle pain/soreness in the arm.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Nausea
Clinical narrative: Felt headache and nausea two days after immunization.
Age: 64.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Nausea, Rash macular, Urticaria
Clinical narrative: Had pain at the injection site and also at the top of my shoulder and in my armpit that I noticed when I woke up. Became extremely nauseous at 5:00 PM.  Went to bed and woke up the next morning (11/12/16) and was no longer nauseous but noticed red blothces that extended midway down my arm, to my shoulder and my neck. The blotches were not puffy like hives and when I touched the areas that were red they were painful.  I went to another store and showed the pharmacist who said that she had another patient eith a similar reacion.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Swelling face
Clinical narrative: Patient reported moderate swelling, redness, itching at injection site that started 24 hours after administration that has continued/increased 48 hours after administration. Area is also warm to touch. Pt also reported mild facial swelling above left cheek but is not sure if related to vaccine.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Pain around injection site (left arm deltoid muscle) then intense pain when attempting to move or raise arm above shoulder. Applied warm compress. Pain still  persists > 1 month later.
Age: 43.0
Sex: F
Vaccine: HEPAB, IPV, MMR, MNQ, TDAP
Symptoms: Asthenia, Back pain, Influenza like illness, Pain
Clinical narrative: FLU-LIKE SYMPTOMS, WEAKNESS, BODY ACHES, BACK PAIN.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Fatigue, Injection site induration, Injection site pain
Clinical narrative: Patient called me 1 day after her vaccination and stated she had a reaction to the pneumococcal shot she received the day before. C/o of slight chills the night of shot, hardness and pain at injection site and tiredness.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: Dizziness when standing from a sitting position. No treatment.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Asthenia, Fatigue, Headache, Nausea
Clinical narrative: Weakness, nausea, stomach cramps, extreme fatigue, headache. Symptoms lasted five days.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: The site of the vaccination has become very red, raised, warm to touch and hard.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site rash, Lymphadenopathy, Malaise, Nasopharyngitis
Clinical narrative: She got a red rash on both arms the first night after the shot. Then in the following days she developed what seemed like a cold, then a day or two later developed a fever and also vomiting. She continued to be sick and was put on antibiotics that did not help. We took her to see a specialist who said her adenoids were swollen. She would then be seen and finally treated with steroids. It took her over 5 months to recover. Until she got her next shot of the same type and then the same symptoms occurred again.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash erythematous, Vomiting
Clinical narrative: She got a red rash on both arms the first night after the shot. Then in the following days she developed what seemed like a cold, then a day or two later developed a fever and also vomiting. She continued to be sick and was put on antibiotics that did not help. We took her to see a specialist who said her adenoids were swollen. She would then be seen and finally treated with steroids. It took her over 5 months to recover. Until she got her next shot of the same type and then the same symptoms occurred again.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Musculoskeletal stiffness, Painful respiration, Pruritus, Urticaria
Clinical narrative: I first noticed my arm was very itchy. Upon further inspection, I noticed a softball sized wheal and the area was erythemic. Later that day (around noon), I noticed I was having some slight wheezing. The intercostal joints in my chest felt stiff and painful to breathe (this resolved the next day), and I developed a moderate amount of pain/sensitivity to my right arm (where the vaccine was administered). The area continued to itch a lot. The wheal lasted approx. 5 days and the itchiness continued for just over a week.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: I first noticed my arm was very itchy. Upon further inspection, I noticed a softball sized wheal and the area was erythemic. Later that day (around noon), I noticed I was having some slight wheezing. The intercostal joints in my chest felt stiff and painful to breathe (this resolved the next day), and I developed a moderate amount of pain/sensitivity to my right arm (where the vaccine was administered). The area continued to itch a lot. The wheal lasted approx. 5 days and the itchiness continued for just over a week.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: Pain and redness at the site of injection. Also body ache.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Muscular weakness, Pain in extremity
Clinical narrative: Flu shot given by Rph. Patient reported pain, weakness in left arm after shot and is seeing an orthopedic physician for inflamed bursa and possible rotator cuff involvement.
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose decreased, Loss of consciousness
Clinical narrative: Pt passed out 2 minutes after receiving flu shot. Pt was caught by friend/wall and did not get hurt. Pt had low blood sugar reported by EMS at scene.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pharyngeal oedema, Swollen tongue
Clinical narrative: Patient experienced swollen tongue and throat about 3 hours following vaccine. had severe chills. Almost resulted in hospitalization.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 13-OCT-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 328 hours, with the recorded temperature of -1.66 degrees Celsius The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 09-OCT-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 232 hours, with the recorded temperature of -1.66 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 31-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 800 hours, with the highest recorded temperature of 48 degrees Fahrenheit and 0.55 to 8.88 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # M032635 with expiry date 05-MAY-2018 and lot# M035104 with expiry date 06-MAY-2016) (dosing details unknown). The administered dose experienced a temperature excursion of 60.1 Fahrenheit(F) for 14 hours and 15 minutes, 47.5 Fahrenheit(F) for 30 minutes, 47.3 Fahrenheit(F) for 30 minutes, 50.7 Fahrenheit(F) for 30 minutes and 32.7 Fahrenheit(F) for 2 hours and 15 minutes. There was no previous temperature excursion. The call was because of a data logger. No symptoms were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose unknown, lot # L025738, expiration date 14-AUG-2017, lot # L038018, expiration date 13-SEP-2017, lot # L048849, expiration date 04-FEB-2018) by unspecified route. The vaccines had been exposed under temperature 1.05 degree Centigrade for 49 hours, but did not undergo previous excursion. Data logger was used. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (dose unknown, lot # L007560, expiration date 15-JUN-2017) by unspecified route. The vaccines had been exposed under temperature 1.05 degree Centigrade for 49 hours, but did not undergo previous excursion. Data logger was used. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ Vial, lot # M019707 with expiry date 25-OCT-2017 (dosing details unknown). The administered dose experienced a temperature excursion of 60.1 Fahrenheit (F) for 14 hours and 15 minutes, 47.5 Fahrenheit (F) for 30 minutes, 47.3 Fahrenheit (F) for 30 minutes, 50.7 Fahrenheit (F) for 30 minutes and 32.7 Fahrenheit (F) for 2 hours and 15 minutes. There was no previous temperature excursion. The call was because of a data logger. No symptoms were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 05-NOV-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 800 hours, with the highest recorded temperature of 1.11 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 08-OCT-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 5208 hours, with the recorded temperature of 1.66 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. On an unknown date the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M024677, expiration date 18-MAY-2018; dose and route unknown). No adverse symptoms were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a "young child" of unknown age. No relevant medical condition or concomitant medication was reported. On an unknown date, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot#, expiration date, strength, route, dose and frequency were not reported) (inappropriate schedule of drug administration0. No adverse effect was reported. Additional information is not expected due to the pharmacist was unable to be reached for follow-up information.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies/reactions were not provided. On 20-SEP-2016, the patient received therapy of TWINRIX (lot/expiration, dose, frequency, route and indication unknown). On 21-OCT-2016, the patient was inadvertently vaccinated with VAQTA (lot/expiration and dose unknown, strength 50/1.0 U/ml, intramuscular, frequency once) (wrong drug administered and interchange of vaccine products). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that the patient received four doses of GARDASIL 9. The patient was supposed to received MENACTRA but the patient received a fourth dose of GARDASIL 9. On 25-SEP-2015, the patient was vaccinated with dose of GARDASIL 9 lot # L014415, 25-JUL-2017, intramuscular. On 17-NOV-2015, the patient was vaccinated with dose 2 of GARDASIL 9 lot # L028083, 03-SEP-2017, intramuscular. On 28-MAR-2016, the patient was vaccinated with dose 3 of GARDASIL 9 lot # L040164, 20-FEB-2018, intramuscular. On 09-NOV-2016, the patient was vaccinated with dose 4 of GARDASIL 9 lot # L014415, 25-JUL-2017, intramuscular. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 03-DEC-2015, the patient was vaccinated with a dose of an improperly stored Gardasil 9 (strength: 0.5 ml) lot# L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 800 hours, with the recorded temperature of -1.66 to 8.8888 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. On an unknown date and the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M024677, expiration date 18-MAY-2018; dose and route unknown). No adverse symptoms were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (dose unknown, lot # L013192, expiration date 19-JAN-2017, lot # M004508, expiration date 29-JUN-2017) orally. The vaccines had been exposed under temperature 1.05 degree centigrade for 49 hours, but did not undergo previous excursion. Data logger was used. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Cardiac murmur, Disability, Guillain-Barre syndrome, Herpes zoster
Clinical narrative: On March 7th, 2013 I received the zoster vaccine. On May 2nd, 2013 I contracted shingles on both sides. On May 8th, 2013 I was admitted to hospital with Guillain-Barre. I spent until July 3rd and was released very handy-capped. I am still very limited in many ways. I found I had no recourse unlike with the flu vaccine. I believe the risk should be advertised by Merck. I am still suffering.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test, Muscle disorder, Respiratory disorder, Visual acuity reduced
Clinical narrative: On March 7th, 2013 I received the zoster vaccine. On May 2nd, 2013 I contracted shingles on both sides. On May 8th, 2013 I was admitted to hospital with Guillain-Barre. I spent until July 3rd and was released very handy-capped. I am still very limited in many ways. I found I had no recourse unlike with the flu vaccine. I believe the risk should be advertised by Merck. I am still suffering.
Age: 68.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Visual impairment
Clinical narrative: This is a spontaneous report from a contactable pharmacy intern and from a contactable health care professional, reporting on behalf of a pharmacist. A currently 69-year-old male patient of an unspecified ethnicity received PREVNAR 13 (NDC number 00005197102; Lot# M06901 and Lot# M0641; Expiration Date Mar2017), intramuscular on  06Apr2016 at 0.5 ml, single dose in the left arm for immunisation.  Medical history included thyroid disorder on unknown date. Patient was diagnosed with this condition 14 years ago and not experiencing it.  The patient's concomitant medications were not reported. The patient experienced change in vision on an unspecified date, 5-6 days after vaccine administration. Patient went to ophthalmologist who gave him different prescription for glasses however he was still having vision problems and it was still persisting. The event was not yet resolved. The reporter did not consider the event Change in vision related to the suspect product. The pharmacist provided causality assessment as Unknown/unlikely. Follow-up (04Nov2016):  Follow-up attempts are completed. No further information is expected. Follow-up (08Nov2016): New information from a contactable pharmacist included causality assessment. Follow-up attempts are completed. No further information is expected. Sender's Comments: Based on the information currently available, the event "Change in vision" is not related to the use of PREVNAR 13, but most likely represents the patient's underlying medical condition.
Age: 68.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Corrective lens user, Visual impairment
Clinical narrative: This is a spontaneous report from a contactable pharmacy intern and from a contactable health care professional, reporting on behalf of a pharmacist. A currently 69-year-old male patient of an unspecified ethnicity received PREVNAR 13 (NDC number 00005197102; Lot# M06901 and Lot# M0641; Expiration Date Mar2017), intramuscular on  06Apr2016 at 0.5 ml, single dose in the left arm for immunisation.  Medical history included thyroid disorder on unknown date. Patient was diagnosed with this condition 14 years ago and not experiencing it.  The patient's concomitant medications were not reported. The patient experienced change in vision on an unspecified date, 5-6 days after vaccine administration. Patient went to ophthalmologist who gave him different prescription for glasses however he was still having vision problems and it was still persisting. The event was not yet resolved. The reporter did not consider the event Change in vision related to the suspect product. The pharmacist provided causality assessment as Unknown/unlikely. Follow-up (04Nov2016):  Follow-up attempts are completed. No further information is expected. Follow-up (08Nov2016): New information from a contactable pharmacist included causality assessment. Follow-up attempts are completed. No further information is expected. Sender's Comments: Based on the information currently available, the event "Change in vision" is not related to the use of PREVNAR 13, but most likely represents the patient's underlying medical condition.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Approximated 9/17/16 patient presented to ED, D/c with dx of pharyngitis. On 9/18/16 patient was admitted to hospital.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pharyngitis
Clinical narrative: Approximated 9/17/16 patient presented to ED, D/c with dx of pharyngitis. On 9/18/16 patient was admitted to hospital.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself received from FDA. Regulatory authority report number is 2017-00031. A 71-year-female patient of an unspecified race received on 21Sep206 PREVNAR 13, (NDC number 000005-1971-02) at 0.5 ml single dose, via an unspecified route, in the left arm for immunization. Concomitant medications and medical history were not reported. On 24Sep2016 the patient experienced that the site on her left arm where the injection was given was red, swollen and hot. On 26Sep2016 she observed rash and edema on the left arm where the vaccine was given and the site was painful for a few days, it hurt to raise the left arm up. On 28Sep2016 the pain was very severe in the left arm. On 28Sep2016 the patient returned where the vaccine was given and a physician gave amoxicillin-clavulanic acid 875 mg twice a day for 7 days. The outcome of the event vaccination site pain was reported as recovered on 28Sep2016 for the other events the outcome was not recovered. Follow-up (08Nov2016): additional information received from the contactable consumer includes age and gender of the patient and onset date of the events.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself received from FDA. Regulatory authority report number is 2017-00031. A 71-year-female patient of an unspecified race received on 21Sep206 PREVNAR 13, (NDC number 000005-1971-02) at 0.5 ml single dose, via an unspecified route, in the left arm for immunization. Concomitant medications and medical history were not reported. On 24Sep2016 the patient experienced that the site on her left arm where the injection was given was red, swollen and hot. On 26Sep2016 she observed rash and edema on the left arm where the vaccine was given and the site was painful for a few days, it hurt to raise the left arm up. On 28Sep2016 the pain was very severe in the left arm. On 28Sep2016 the patient returned where the vaccine was given and a physician gave amoxicillin-clavulanic acid 875 mg twice a day for 7 days. The outcome of the event vaccination site pain was reported as recovered on 28Sep2016 for the other events the outcome was not recovered. Follow-up (08Nov2016): additional information received from the contactable consumer includes age and gender of the patient and onset date of the events.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site warmth, Pain, Pain in extremity, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself received from FDA. Regulatory authority report number is 2017-00031. A 71-year-female patient of an unspecified race received on 21Sep206 PREVNAR 13, (NDC number 000005-1971-02) at 0.5 ml single dose, via an unspecified route, in the left arm for immunization. Concomitant medications and medical history were not reported. On 24Sep2016 the patient experienced that the site on her left arm where the injection was given was red, swollen and hot. On 26Sep2016 she observed rash and edema on the left arm where the vaccine was given and the site was painful for a few days, it hurt to raise the left arm up. On 28Sep2016 the pain was very severe in the left arm. On 28Sep2016 the patient returned where the vaccine was given and a physician gave amoxicillin-clavulanic acid 875 mg twice a day for 7 days. The outcome of the event vaccination site pain was reported as recovered on 28Sep2016 for the other events the outcome was not recovered. Follow-up (08Nov2016): additional information received from the contactable consumer includes age and gender of the patient and onset date of the events.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Injection was unusually painful. Immediately had decrease mobility and severe pain until next morning then had mild to moderate pain which I have to this date. Saw family Dr. 10-21 and she referred me to Ortho whom I saw on 10-25. MRI 10-31. Physical therapy started 11-4. I requested a copy of initial VAERS Report from pharmacy and noted inaccuracies. I talked with Public Health dept. and was instructed to send in a report myself.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Immediate post-injection reaction, Injection site pain, Mobility decreased, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Injection was unusually painful. Immediately had decrease mobility and severe pain until next morning then had mild to moderate pain which I have to this date. Saw family Dr. 10-21 and she referred me to Ortho whom I saw on 10-25. MRI 10-31. Physical therapy started 11-4. I requested a copy of initial VAERS Report from pharmacy and noted inaccuracies. I talked with Public Health dept. and was instructed to send in a report myself.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain
Clinical narrative: Injection was unusually painful. Immediately had decrease mobility and severe pain until next morning then had mild to moderate pain which I have to this date. Saw family Dr. 10-21 and she referred me to Ortho whom I saw on 10-25. MRI 10-31. Physical therapy started 11-4. I requested a copy of initial VAERS Report from pharmacy and noted inaccuracies. I talked with Public Health dept. and was instructed to send in a report myself.
Age: 36.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Flu Shot given, some pain at time of injection, soreness x2 weeks.  Day 13 woke with increased shoulder pain, difficulty raising arm, turning arm, and lifting.  Employee was sent to clinic for evaluation where she was diagnosed with Bursitis of Left Shoulder.  3 View Left Shoulder Xray was ordered as well as lifting restrictions (no lifting more than 10 pounds (floor to waist), no lifting more than 10 pounds (waist to shoulder), no forceful pushing or pulling, and no reaching or overhead work). Employee was prescribed Prednisone by clinic for 5 days. This continues to be an ongoing case.
Age: 36.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray limb
Clinical narrative: Flu Shot given, some pain at time of injection, soreness x2 weeks.  Day 13 woke with increased shoulder pain, difficulty raising arm, turning arm, and lifting.  Employee was sent to clinic for evaluation where she was diagnosed with Bursitis of Left Shoulder.  3 View Left Shoulder Xray was ordered as well as lifting restrictions (no lifting more than 10 pounds (floor to waist), no lifting more than 10 pounds (waist to shoulder), no forceful pushing or pulling, and no reaching or overhead work). Employee was prescribed Prednisone by clinic for 5 days. This continues to be an ongoing case.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Peripheral swelling, Pharyngeal oedema, Pruritus
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of anaphylaxis in a 29-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9ES22, expiry date 30th June 2017). Previously administered products included Flu vaccine with an associated reaction of adverse reaction (for tolerance to dose of flu vaccine refer case US2016GSK167849). On an unknown date, the patient received FLUARIX QUADRIVALENT. In October 2016, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling and injection site itching. On an unknown date, the patient experienced anaphylaxis (serious criteria GSK medically significant), allergic reaction and throat swelling. The patient was treated with BENADRYL, dexamethasone, epinephrine and PEPCID. On an unknown date, the outcome of the anaphylaxis and allergic reaction were unknown and the outcome of the throat swelling, injection site swelling and injection site itching were recovered/resolved. The reporter considered the anaphylaxis, allergic reaction, throat swelling, injection site swelling and injection site itching to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient's age at vaccination was not reported. Less than a year, after receiving FLUARIX QUADRIVALENT the patient experienced anaphylaxis and throat swelling. The reporter did not know if it was actually anaphylaxis or just an allergic reaction. The patient received BENADRYL for treatment of injection site itching and swelling and the patient experienced throat swelling. The patient then visited emergency room and was given epinephrine, dexamethasone, and PEPCID and symptoms resolved. No overnight hospitalization reported. This was 3rd of 5 cases reported by the same reporter. This case was linked with US2016GSK167849, as reported for the same patient.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Hypersensitivity, Injection site pruritus, Injection site swelling, Pharyngeal oedema
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of anaphylaxis in a 29-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9ES22, expiry date 30th June 2017). Previously administered products included Flu vaccine with an associated reaction of adverse reaction (for tolerance to dose of flu vaccine refer case US2016GSK167849). On an unknown date, the patient received FLUARIX QUADRIVALENT. In October 2016, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling and injection site itching. On an unknown date, the patient experienced anaphylaxis (serious criteria GSK medically significant), allergic reaction and throat swelling. The patient was treated with BENADRYL, dexamethasone, epinephrine and PEPCID. On an unknown date, the outcome of the anaphylaxis and allergic reaction were unknown and the outcome of the throat swelling, injection site swelling and injection site itching were recovered/resolved. The reporter considered the anaphylaxis, allergic reaction, throat swelling, injection site swelling and injection site itching to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient's age at vaccination was not reported. Less than a year, after receiving FLUARIX QUADRIVALENT the patient experienced anaphylaxis and throat swelling. The reporter did not know if it was actually anaphylaxis or just an allergic reaction. The patient received BENADRYL for treatment of injection site itching and swelling and the patient experienced throat swelling. The patient then visited emergency room and was given epinephrine, dexamethasone, and PEPCID and symptoms resolved. No overnight hospitalization reported. This was 3rd of 5 cases reported by the same reporter. This case was linked with US2016GSK167849, as reported for the same patient.
Age: 69.0
Sex: F
Vaccine: PNC13, FLU3, PNC13
Symptoms: Injection site erythema, Tenderness
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported the same event for 3 patients. This is the first of three reports. A 69-year-old female patient received PREVNAR 13, (NDC number 0005197102, Lot Number: M98915, Expire Date: Sep 2017) at 0.5ml single dose for immunization via intramuscular route in the right arm on 28Oct2016. The patient received also AFLURIA (manufacturer: Seqirus, NDC number 3333201601, Lot Number: WT58708, Expire Date: 30Jun2017) on 02Nov2016 into the left arm for immunization. On 29Oct2016 the patient experienced increased redness at the injection site of the prevnar 13. The outcome of the event was unknown. The patient had received Afluria in the past.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016527789 same reporter/different patient, same product, same event;US-PFIZER INC-2016527790 same reporter/different patient, same product, same event
Age: 69.0
Sex: F
Vaccine: PNC13, FLU3, PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported the same event for 3 patients. This is the first of three reports. A 69-year-old female patient received PREVNAR 13, (NDC number 0005197102, Lot Number: M98915, Expire Date: Sep 2017) at 0.5ml single dose for immunization via intramuscular route in the right arm on 28Oct2016. The patient received also AFLURIA (manufacturer: Seqirus, NDC number 3333201601, Lot Number: WT58708, Expire Date: 30Jun2017) on 02Nov2016 into the left arm for immunization. On 29Oct2016 the patient experienced increased redness at the injection site of the prevnar 13. The outcome of the event was unknown. The patient had received Afluria in the past.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016527789 same reporter/different patient, same product, same event;US-PFIZER INC-2016527790 same reporter/different patient, same product, same event
Age: 65.0
Sex: F
Vaccine: PNC13, FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported the same event for 3 patients. This is the 2nd of three reports. A 65-year-old female patient received PREVNAR 13 (NDC number 0005197102, Lot Number: M98915, Expire Date: Sep2017), intramuscular at 0.5 ml, single in the left arm on 01Nov2016 for immunisation. The patient medical history was not reported. Concomitant medication included AFLURIA (NDC number 3333201601, Lot Number: WT58708, Expire Date: 30Jun2017) intramuscular at 0.5 ml, single in the right arm on 01Nov2016 for immunisation. The patient previously took AFLURIA. On 02Nov2016, the patient experienced increased redness at the injection site of the PREVNAR 13, left arm with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016527786 Same reporter/different patient, same product, same event; US-PFIZER INC-2016527790 Same reporter/different patient, same product, same event.
Age: 65.0
Sex: F
Vaccine: PNC13, FLU3, PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported the same event for 3 patients. This is the 2nd of three reports. A 65-year-old female patient received PREVNAR 13 (NDC number 0005197102, Lot Number: M98915, Expire Date: Sep2017), intramuscular at 0.5 ml, single in the left arm on 01Nov2016 for immunisation. The patient medical history was not reported. Concomitant medication included AFLURIA (NDC number 3333201601, Lot Number: WT58708, Expire Date: 30Jun2017) intramuscular at 0.5 ml, single in the right arm on 01Nov2016 for immunisation. The patient previously took AFLURIA. On 02Nov2016, the patient experienced increased redness at the injection site of the PREVNAR 13, left arm with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016527786 Same reporter/different patient, same product, same event; US-PFIZER INC-2016527790 Same reporter/different patient, same product, same event.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Tuberculin test negative, Vaccination site irritation, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient also received a PPD skin test that day (negative). Later on, around the end of the day, the vaccination area was red, swollen and puffy. It got more puffy/irritated/hot over time.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Crying, Deafness, Dyskinesia, Eye movement disorder, Fatigue
Clinical narrative: Patient received a flu shot and her second GARDASIL 9. She was nervous in the immediate time period right before the shots were administered. She then said it hurt a lot. Approximately 1-2 minutes later she said, "I feel sick". She was as white as a sheet, then fainted leaning forward. I caught her and lay her down across her sister, who was seated on the exam table next to her. Her eyes rolled back, she started smacking her lips, and then had small jerking movements of all four extremities. This lasted approximately 10 seconds. She woke, complained of not being able to hear, and started crying. She calmed down after several minutes. She was lay down for 15 minutes and was given juice. She had fatigue and was subdued for the next 36 hours. She slept 11 hours that night, which is atypical, and then stayed in bed the next day until the evening.