chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Catatonia, Computerised tomogram normal, Confusional state, Decreased appetite
Clinical narrative: Patient is a 47 year-old female with no significant prior medical history. She had a series of multiple vaccinations from 17Mar2017 through 9Apr2017 in preparation for a planned mission trip to Africa.  The vaccinations administered in this 3-week period included Yellow Fever (SQ), Rabies x3 (IM), Polio (SQ), Hepatitis A (IM), Hepatitis B (IM), Typhoid (PO), and Meningitis. The vaccines were administered at the medical office as well as at her PCPs office. Onset of symptoms began 10Apr2017 including severe insomnia, loss of appetite, weight loss, heart palpitations, and general anxiety with isolated panic attacks. On 20Apr2017 patient visited PCP who prescribed Lexapro (10mg qd).    Patient had first of a series of psychotic episodes on 26Apr2017, lasting two days until 28Apr2017.  Episode included panic, paranoia, delusions, and confusion.  Patient was not hospitalized, but on 28Apr2017 visited PCP who prescribed Xanax (0.25mg qd) and Remeron  (7.5mg qd) stopping the Lexapro.    Patient had second psychotic episode on 26May2017 where she was in a catatonic state for 5 days.  Patient was unresponsive to surroundings and self-reports having been in a delusional alternate state during this period.  Full medical work-up was done with no findings.  CT scan was normal and all lab-work within normal limits.  Patient was in the hospital for 8 days and was discharged on Ativan (1mg bid) and amitriptyline (5mg qd).    Patient had third psychotic episode on 24Jun2017 that required 18-day hospitalization.  Again, etiology of psychosis was unknown with normal CT scan and all lab-work within normal limits.  All medications were withdrawn for 7 days with no improvement of symptoms. Patient was discharged on Ativan (1mg bid) and Zyprexa (15mg qd).  To date, patient has ongoing severe insomnia, general anxiety, and sensitivity to external stimuli.  Her medical team has been unable to identify an underlying cause of the psychotic episodes, but cannot rule out that the series of vaccinations were involved due to the relative timing of events.  Patient has had significant impact to quality of life and unfortunately has been on medical leave from her employment since 27May2017 with unknown date of medical clearance for return.
Age: 47.0
Sex: F
Vaccine: RAB
Symptoms: Delusion, Haematology test normal, Impaired work ability, Insomnia, Laboratory test normal
Clinical narrative: Patient is a 47 year-old female with no significant prior medical history. She had a series of multiple vaccinations from 17Mar2017 through 9Apr2017 in preparation for a planned mission trip to Africa.  The vaccinations administered in this 3-week period included Yellow Fever (SQ), Rabies x3 (IM), Polio (SQ), Hepatitis A (IM), Hepatitis B (IM), Typhoid (PO), and Meningitis. The vaccines were administered at the medical office as well as at her PCPs office. Onset of symptoms began 10Apr2017 including severe insomnia, loss of appetite, weight loss, heart palpitations, and general anxiety with isolated panic attacks. On 20Apr2017 patient visited PCP who prescribed Lexapro (10mg qd).    Patient had first of a series of psychotic episodes on 26Apr2017, lasting two days until 28Apr2017.  Episode included panic, paranoia, delusions, and confusion.  Patient was not hospitalized, but on 28Apr2017 visited PCP who prescribed Xanax (0.25mg qd) and Remeron  (7.5mg qd) stopping the Lexapro.    Patient had second psychotic episode on 26May2017 where she was in a catatonic state for 5 days.  Patient was unresponsive to surroundings and self-reports having been in a delusional alternate state during this period.  Full medical work-up was done with no findings.  CT scan was normal and all lab-work within normal limits.  Patient was in the hospital for 8 days and was discharged on Ativan (1mg bid) and amitriptyline (5mg qd).    Patient had third psychotic episode on 24Jun2017 that required 18-day hospitalization.  Again, etiology of psychosis was unknown with normal CT scan and all lab-work within normal limits.  All medications were withdrawn for 7 days with no improvement of symptoms. Patient was discharged on Ativan (1mg bid) and Zyprexa (15mg qd).  To date, patient has ongoing severe insomnia, general anxiety, and sensitivity to external stimuli.  Her medical team has been unable to identify an underlying cause of the psychotic episodes, but cannot rule out that the series of vaccinations were involved due to the relative timing of events.  Patient has had significant impact to quality of life and unfortunately has been on medical leave from her employment since 27May2017 with unknown date of medical clearance for return.
Age: 47.0
Sex: F
Vaccine: RAB
Symptoms: Musculoskeletal stiffness, Palpitations, Panic attack, Paranoia, Psychiatric symptom
Clinical narrative: Patient is a 47 year-old female with no significant prior medical history. She had a series of multiple vaccinations from 17Mar2017 through 9Apr2017 in preparation for a planned mission trip to Africa.  The vaccinations administered in this 3-week period included Yellow Fever (SQ), Rabies x3 (IM), Polio (SQ), Hepatitis A (IM), Hepatitis B (IM), Typhoid (PO), and Meningitis. The vaccines were administered at the medical office as well as at her PCPs office. Onset of symptoms began 10Apr2017 including severe insomnia, loss of appetite, weight loss, heart palpitations, and general anxiety with isolated panic attacks. On 20Apr2017 patient visited PCP who prescribed Lexapro (10mg qd).    Patient had first of a series of psychotic episodes on 26Apr2017, lasting two days until 28Apr2017.  Episode included panic, paranoia, delusions, and confusion.  Patient was not hospitalized, but on 28Apr2017 visited PCP who prescribed Xanax (0.25mg qd) and Remeron  (7.5mg qd) stopping the Lexapro.    Patient had second psychotic episode on 26May2017 where she was in a catatonic state for 5 days.  Patient was unresponsive to surroundings and self-reports having been in a delusional alternate state during this period.  Full medical work-up was done with no findings.  CT scan was normal and all lab-work within normal limits.  Patient was in the hospital for 8 days and was discharged on Ativan (1mg bid) and amitriptyline (5mg qd).    Patient had third psychotic episode on 24Jun2017 that required 18-day hospitalization.  Again, etiology of psychosis was unknown with normal CT scan and all lab-work within normal limits.  All medications were withdrawn for 7 days with no improvement of symptoms. Patient was discharged on Ativan (1mg bid) and Zyprexa (15mg qd).  To date, patient has ongoing severe insomnia, general anxiety, and sensitivity to external stimuli.  Her medical team has been unable to identify an underlying cause of the psychotic episodes, but cannot rule out that the series of vaccinations were involved due to the relative timing of events.  Patient has had significant impact to quality of life and unfortunately has been on medical leave from her employment since 27May2017 with unknown date of medical clearance for return.
Age: 47.0
Sex: F
Vaccine: RAB
Symptoms: Psychotic disorder, Quality of life decreased, Unresponsive to stimuli, Weight decreased
Clinical narrative: Patient is a 47 year-old female with no significant prior medical history. She had a series of multiple vaccinations from 17Mar2017 through 9Apr2017 in preparation for a planned mission trip to Africa.  The vaccinations administered in this 3-week period included Yellow Fever (SQ), Rabies x3 (IM), Polio (SQ), Hepatitis A (IM), Hepatitis B (IM), Typhoid (PO), and Meningitis. The vaccines were administered at the medical office as well as at her PCPs office. Onset of symptoms began 10Apr2017 including severe insomnia, loss of appetite, weight loss, heart palpitations, and general anxiety with isolated panic attacks. On 20Apr2017 patient visited PCP who prescribed Lexapro (10mg qd).    Patient had first of a series of psychotic episodes on 26Apr2017, lasting two days until 28Apr2017.  Episode included panic, paranoia, delusions, and confusion.  Patient was not hospitalized, but on 28Apr2017 visited PCP who prescribed Xanax (0.25mg qd) and Remeron  (7.5mg qd) stopping the Lexapro.    Patient had second psychotic episode on 26May2017 where she was in a catatonic state for 5 days.  Patient was unresponsive to surroundings and self-reports having been in a delusional alternate state during this period.  Full medical work-up was done with no findings.  CT scan was normal and all lab-work within normal limits.  Patient was in the hospital for 8 days and was discharged on Ativan (1mg bid) and amitriptyline (5mg qd).    Patient had third psychotic episode on 24Jun2017 that required 18-day hospitalization.  Again, etiology of psychosis was unknown with normal CT scan and all lab-work within normal limits.  All medications were withdrawn for 7 days with no improvement of symptoms. Patient was discharged on Ativan (1mg bid) and Zyprexa (15mg qd).  To date, patient has ongoing severe insomnia, general anxiety, and sensitivity to external stimuli.  Her medical team has been unable to identify an underlying cause of the psychotic episodes, but cannot rule out that the series of vaccinations were involved due to the relative timing of events.  Patient has had significant impact to quality of life and unfortunately has been on medical leave from her employment since 27May2017 with unknown date of medical clearance for return.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Injection site erythema, Injection site rash, Injection site warmth, Lethargy
Clinical narrative: PATIENT HAS A RED RASH ON SHOULDER AROUND THE INJECTION SITE, PATIENT STATES THAT THE RASH IS SPREADING. THE AREA IS VERY WARM TO THE TOUCH. PATIENT SAYS ARM THAT WAS INJECTED IS SORE AND HURTS TO MOVE. SHE ALSO NOTES THAT SHE FEELS VERY LETHARGIC, PATIENT FEELS MENTALLY CLOUDY. SHE STATES THAT THIS IS NOT NORMAL FOR HER.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: PATIENT HAS A RED RASH ON SHOULDER AROUND THE INJECTION SITE, PATIENT STATES THAT THE RASH IS SPREADING. THE AREA IS VERY WARM TO THE TOUCH. PATIENT SAYS ARM THAT WAS INJECTED IS SORE AND HURTS TO MOVE. SHE ALSO NOTES THAT SHE FEELS VERY LETHARGIC, PATIENT FEELS MENTALLY CLOUDY. SHE STATES THAT THIS IS NOT NORMAL FOR HER.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Febrile convulsion, Mouth ulceration, Oropharyngeal pain, Pyrexia, Tonsillar ulcer
Clinical narrative: Afternoon of 7/7/2017 patient started getting a fever. This quickly jumped to 102 F during her nap and resulted in a febrile seizure. She was admitted to the emergency department, where they found a mild UTI that they associated with the fever and she was dishcarged with an antibiotics prescription, but there were no other signs of a UTI (pain urinating, reluctance to urinate, etc) exhibited by Arielle. The next day she complained of a sore throat, and had canker-like sores all over her mouth/tonsils. Her fever continued three days until it resolved and the symptoms were treated with Tylenol along with her antibiotic. So mainly: Febrile seizure, sores in throat.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Urinary tract infection, Urine analysis
Clinical narrative: Afternoon of 7/7/2017 patient started getting a fever. This quickly jumped to 102 F during her nap and resulted in a febrile seizure. She was admitted to the emergency department, where they found a mild UTI that they associated with the fever and she was dishcarged with an antibiotics prescription, but there were no other signs of a UTI (pain urinating, reluctance to urinate, etc) exhibited by Arielle. The next day she complained of a sore throat, and had canker-like sores all over her mouth/tonsils. Her fever continued three days until it resolved and the symptoms were treated with Tylenol along with her antibiotic. So mainly: Febrile seizure, sores in throat.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient called the pharmacy to inform us that she developed a full blown case of shingles after the receiving the vaccine this past Monday 7/17/2017. The patient is going to urgent care to be treated for this condition.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pyrexia, Swelling
Clinical narrative: Fever/myalgia/swelling starting a few hours after vaccination. Pt iced and took ibuprofen. Fever was no longer present following morning, swelling no longer present 3 days after.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash erythematous
Clinical narrative: Patient expresses a feeling of itching coming from within body, has small red bumps on torso, arms and groin area, if he starts itching it makes it worse, he has tried cream which hasn't helped.
Age: 55.0
Sex: M
Vaccine: DTAP
Symptoms: Diagnostic procedure, Disorientation, Memory impairment, Nausea, Pyrexia
Clinical narrative: Fever, nausea , disoriented, ringing in my ears, forgetfulness for months. Brain tracers, vision problems.
Age: 55.0
Sex: M
Vaccine: DTAP
Symptoms: Tinnitus, Visual impairment
Clinical narrative: Fever, nausea , disoriented, ringing in my ears, forgetfulness for months. Brain tracers, vision problems.
Age: 35.0
Sex: U
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Hard at injection site, swollen, painful.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: Patient had soreness and redness at injection site, and severe body aches. This occurred a few hours after the injection. There was no improvement the next day.
Age: 68.0
Sex: F
Vaccine: YF
Symptoms: Blood urine present
Clinical narrative: BLOOD IN URINE.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Inflammation, Injection site swelling
Clinical narrative: Pt got vaccine Monday and experienced swelling at site of injection had to see her doctor to get antibiotics and steroids to treat inflammation.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Lymph node pain, Lymphadenopathy, Mouth ulceration
Clinical narrative: Painful oral ulcers within 24 hours, ipsilateral painful tender enlarged axillary lymph node.
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Laboratory test, Muscle spasms, Tremor, Urinary retention, Vaccination complication
Clinical narrative: Muscle cramps  / couldn't use rest room/ shaking. Started next morning, 2days later admitted  to hospital. Doctor said reaction to influence injection. 2years 6months. Many other Doctors also involved.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Nodule, Pain, Peripheral swelling, Tenderness
Clinical narrative: Customer called to report a local reaction at the site of injection. stated she had a "knot" on her arm less than 1 inch in diameter. Advised to apply ice pack and take 50mg diphenhydramine every 6 hours as needed. Advised to monitor BP and if breathing problems or worsening of symptoms to seek medical attention. Checked with customer at 5:05 pm; pain subsiding. On follow up with patient, customer on Sunday 7-23-17, she stated that the swelling spread out on arm, "not real bad" tender but she felt it was impoving. Still using ice and diphenhydramine.
Age: 16.0
Sex: M
Vaccine: TYP, YF
Symptoms: Blood glucose normal, Immediate post-injection reaction, Loss of consciousness, Seizure
Clinical narrative: Immediately following bandage application over site of yellow fever vaccination, patient lost consciousness and had a seizure lasting less than 2 seconds. Emergency services were contacted by another pharmacy associate, patient immediately started coming through, took about 2 minutes before he was aware of his surroundings. Patient was given some food and water while he was recovering. 10 minutes after vaccination, emergency services arrived, took vitals, and declared patient had no symptoms and all health information was normal. Parents elected to have them take him to hospital for further observation.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Gaze palsy, Muscle twitching, Neurological symptom, Pain, Seizure like phenomena
Clinical narrative: My son took the Meningitis Vaccine and had no reaction. We were in fact laughing and joking at how little it hurt. However, after the HPV vaccine, the nurse was telling us to let her know if he was dizzy. My son immediately rolled his eyes back and started to twitch and then fainted and was unresponsive for a few seconds. It was very very disturbing and obviously a neurological response. To me it looked like a mini-seizure.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: My son took the Meningitis Vaccine and had no reaction. We were in fact laughing and joking at how little it hurt. However, after the HPV vaccine, the nurse was telling us to let her know if he was dizzy. My son immediately rolled his eyes back and started to twitch and then fainted and was unresponsive for a few seconds. It was very very disturbing and obviously a neurological response. To me it looked like a mini-seizure.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: Extreme pain in arm throughout night/couldn't sleep. Raised red hot where injection was placed. I iced the area several times and took Advil. Reported information to Dr.'s office. Slight red still remains after almost 2 weeks?!?....Itchy at injection site during 2nd week.  Odd!
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Extreme pain in arm throughout night/couldn't sleep. Raised red hot where injection was placed. I iced the area several times and took Advil. Reported information to Dr.'s office. Slight red still remains after almost 2 weeks?!?....Itchy at injection site during 2nd week.  Odd!
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Altered state of consciousness, Dizziness, Hyperhidrosis, Immediate post-injection reaction, Nausea
Clinical narrative: PATIENT WAS FEELING LIGHTHEADED WITHIN MOMENTS OF RECEIVING VACCINE. WITHIN A FEW MINUTES, THE PATIENT WAS SWEATY, NAUSEATED, AND STATED SHE FELT LIKE SHE WAS "GOING TO THROW UP AND/OR PASS OUT".  AFTER ABOUT 10 MINUTES, SHE WAS FEELING MUCH BETTER.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left upper arm swelling with erythema and tenderness over upper arm, shoulder and superior chest.
Age: 12.0
Sex: F
Vaccine: HPV9, MEN, PPV
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Hypoaesthesia
Clinical narrative: ~5 minutes after receiving vaccinations, child had a sudden pain in chest/heaviness in chest and was short of breath. Also reported numbness in face. Medical staff assisted with having child lay down with legs elevated and kept warm, gave fluids (Gatorade). Event lasted ~ 2 minutes.  Child felt better after drinking Gatorade.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: G1P0 28 week and 3 day OB EDC OCT/10/2017. Left deltoid Erythema Swelling 4x5cm.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Blood alcohol, Computerised tomogram head, Differential white blood cell count, Dysarthria, Facial paralysis
Clinical narrative: The evening after getting my vaccine I had a sharp pain behind my right ear and severe headache but did not get concerned thinking it was just a common side effect. On Wednesday the 19th I felt tired and had a headache most of the day but still didn't feel there was anything to be concerned about. On the evening of the 20th while eating with friends they noticed my eyelid drooping and the corner of my mouth also drooping and my speech becoming slurred. Our guest included a retired Nurse anesthesiologist who suggest I get medical treatment right away. I went to Convenient care who sent me to the emergency room.  I was told I had developed Bell Palsy and it could have been part of a reaction to my Pneumonia vaccination.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Full blood count, Headache, International normalised ratio, Metabolic function test, Pain
Clinical narrative: The evening after getting my vaccine I had a sharp pain behind my right ear and severe headache but did not get concerned thinking it was just a common side effect. On Wednesday the 19th I felt tired and had a headache most of the day but still didn't feel there was anything to be concerned about. On the evening of the 20th while eating with friends they noticed my eyelid drooping and the corner of my mouth also drooping and my speech becoming slurred. Our guest included a retired Nurse anesthesiologist who suggest I get medical treatment right away. I went to Convenient care who sent me to the emergency room.  I was told I had developed Bell Palsy and it could have been part of a reaction to my Pneumonia vaccination.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Prothrombin time
Clinical narrative: The evening after getting my vaccine I had a sharp pain behind my right ear and severe headache but did not get concerned thinking it was just a common side effect. On Wednesday the 19th I felt tired and had a headache most of the day but still didn't feel there was anything to be concerned about. On the evening of the 20th while eating with friends they noticed my eyelid drooping and the corner of my mouth also drooping and my speech becoming slurred. Our guest included a retired Nurse anesthesiologist who suggest I get medical treatment right away. I went to Convenient care who sent me to the emergency room.  I was told I had developed Bell Palsy and it could have been part of a reaction to my Pneumonia vaccination.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Early cellulitis - warmth, swelling in the arm, mild redness. pain in the arm up to the neck started 2 days after injection. Treated 3rd day with OTC antihistamine and analgesic. Treated 4th day with ZPAK - pt reports she tolerated the abx since she had other abx med allergies.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Pt. came back to pharmacy 3 days after receiving ZOSTAVAX vaccine. Her arm - around injection site was swollen and red. Pt. is putting ice on it, taking BENADRYL, and calling her Dr. Monday if it doesn't get better. She said it was painful as well. There is still pain in arm.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Nausea, Rash
Clinical narrative: Rash on arm within 30  minutes. Spread to patients back and opposite arm within 1 hour. Dizziness and nausea experienced next day.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site reaction, Muscular weakness
Clinical narrative: October 7, 2016, I took your shot, pneumococcal polysaccharide vaccine (PPSV23). I felt a knot in my right arm, right away, right where the shot was given. No after 9 months I can still feel that knot in my arm. On August 7, 2017, it will be ten months. I went to my doctor, she referred me to out Wellness Center, where did 12 weeks of therapy. It didn't help. My arm hurts every day. I can pinpoint that same spot. The knot is still there. I am 70 years old. I am in very good health. I have never experienced anything like this. I own a business which requires the use of both arms. I am right-handed so that makes the problem even worse. Patient comes in with 3 complaints today, areas of concern on her face, ongoing pain in R arm post influenza and pneumonia vaccination and use of atenolol periodically for extreme anxiety.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Anxiety, Immediate post-injection reaction, Injection site nodule, Pain in extremity
Clinical narrative: October 7, 2016, I took your shot, pneumococcal polysaccharide vaccine (PPSV23). I felt a knot in my right arm, right away, right where the shot was given. No after 9 months I can still feel that knot in my arm. On August 7, 2017, it will be ten months. I went to my doctor, she referred me to out Wellness Center, where did 12 weeks of therapy. It didn't help. My arm hurts every day. I can pinpoint that same spot. The knot is still there. I am 70 years old. I am in very good health. I have never experienced anything like this. I own a business which requires the use of both arms. I am right-handed so that makes the problem even worse. Patient comes in with 3 complaints today, areas of concern on her face, ongoing pain in R arm post influenza and pneumonia vaccination and use of atenolol periodically for extreme anxiety.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS, PPV, VARZOS
Symptoms: Neuralgia
Clinical narrative: Information has been received from a pharmacist referring to a 68 year old female patient. Information about concomitant therapy and concurrent condition was unknown. The patient had no medical history. Drug reactions/allergies included metronidazole (FLAGYL) and phenytoin (DILANTIN). On 07-JUN-2017, at an unspecified pharmacy, the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, route, lot # and expiration date unknown) and PNEUMOVAX23 (dose, route, lot # and expiration date unknown) with sterile diluent (manufacturer unknown) in the right arm for prevent shingles and pneumonia. On approximately 12-JUN-2017 (reported as approximately 5 days later), the patient developed pain in the right buttocks that radiated down her right leg and was incapacitated for 2 weeks. The patient was in constant pain and was not able to complete her normal daily task. There was no intervention to prevent serious criteria. The patient was treated by her physician for "low back pain/sciatica" on 07-JUL-2017 with a steroid injection without relief. The outcome of the events was unrecovered. The causality assessment was unknown. The events were considered as incapacity/disability by the reporter.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS, PPV, VARZOS
Symptoms: Dyspnoea, Musculoskeletal pain, Pain in extremity, Spinal X-ray
Clinical narrative: Information has been received from a pharmacist referring to a 68 year old female patient. Information about concomitant therapy and concurrent condition was unknown. The patient had no medical history. Drug reactions/allergies included metronidazole (FLAGYL) and phenytoin (DILANTIN). On 07-JUN-2017, at an unspecified pharmacy, the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, route, lot # and expiration date unknown) and PNEUMOVAX23 (dose, route, lot # and expiration date unknown) with sterile diluent (manufacturer unknown) in the right arm for prevent shingles and pneumonia. On approximately 12-JUN-2017 (reported as approximately 5 days later), the patient developed pain in the right buttocks that radiated down her right leg and was incapacitated for 2 weeks. The patient was in constant pain and was not able to complete her normal daily task. There was no intervention to prevent serious criteria. The patient was treated by her physician for "low back pain/sciatica" on 07-JUL-2017 with a steroid injection without relief. The outcome of the events was unrecovered. The causality assessment was unknown. The events were considered as incapacity/disability by the reporter.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS, PPV, VARZOS
Symptoms: Back pain, Loss of personal independence in daily activities, Musculoskeletal pain, Pain in extremity, Sciatica
Clinical narrative: Information has been received from a pharmacist referring to a 68 year old female patient. Information about concomitant therapy and concurrent condition was unknown. The patient had no medical history. Drug reactions/allergies included metronidazole (FLAGYL) and phenytoin (DILANTIN). On 07-JUN-2017, at an unspecified pharmacy, the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, route, lot # and expiration date unknown) and PNEUMOVAX23 (dose, route, lot # and expiration date unknown) with sterile diluent (manufacturer unknown) in the right arm for prevent shingles and pneumonia. On approximately 12-JUN-2017 (reported as approximately 5 days later), the patient developed pain in the right buttocks that radiated down her right leg and was incapacitated for 2 weeks. The patient was in constant pain and was not able to complete her normal daily task. There was no intervention to prevent serious criteria. The patient was treated by her physician for "low back pain/sciatica" on 07-JUL-2017 with a steroid injection without relief. The outcome of the events was unrecovered. The causality assessment was unknown. The events were considered as incapacity/disability by the reporter.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 04-JAN-2017 the patient was vaccinated with ZOSTAVAX lot # M035695 for prophylaxis. On an unknown date the patient experienced no adverse event and extra dose administered. The outcome of extra dose administered and no adverse event is unknown. The reporter considered no adverse event and extra dose administered to be not related to ZOSTAVAX.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received on 29-JUN-2017 from a licensed vocational nurse (LVN) referring to a patient of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. The licensed vocational nurse (LVN) reported that on 28-JUN-2017 the patient was administered an expired M-M-R II (Lot number L023386 with expiration date of 25-JUN-2017), (dose, site of administration and route of administration were not reported) for prophylaxis. No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received on 30-JUN-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 26-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M035696, expiration 07-NOV-2017 subcutaneous for prophylaxis which was improperly stored. Concomitant therapies included sterile diluent (lot number M026304 expiration 13-MAR-2019. The pharmacist confirmed that no adverse events were present for the patient. The vaccine was stored at temperatures of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 24 hours 30 minutes and at temperatures of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 8 hours 39 minutes. The pharmacist reported a previous temperature excursion but did not have the details. The call was made due to a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA008451: US-009507513-1707USA008452: US-009507513-1707USA008453: US-009507513-1707USA008454: US-009507513-1707USA008455.
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information was received from a medical assistant regarding a 15-month-old female who was administered a dose of PROQUAD on 28-JUN-2017 (lot #M031942, exp 27-DEC-2017) instead of  MMRII. Medical history and concomitant medication was not reported. No adverse event was reported.  Additional information has been requested.
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 03-JUL-2017 the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(V120), (route not specified) (lot # M046140, expiration date 27-SEP-2019) for prophylaxis; that was found to be improperly stored. Temperature: 47 degrees Fahrenheit to 77 degrees Fahrenheit. Time frame: 20 minutes. No previous temperature excursion. Identified by data logger. No adverse event was reported. No further information to report. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Back pain, Impaired driving ability, Loss of personal independence in daily activities, Musculoskeletal pain, Pain in extremity
Clinical narrative: Information was received from a pharmacist, referring to a 69 year old male patient. On 07-JUN-2017, at an unspecified pharmacy, the patient was administered reconstituted ZOSTAVAX vial 19400 PFU, PNEUMOVAX23 and sterile diluent in the right arm for prophylaxis (product use issue). On approximately 12-JUN-2017 (reported as "5 days later"), the patient developed constant pain in the right buttocks that radiated down his right leg and was incapacitated for 2 weeks. The patient remained in constant pain and he was not able to complete his normal daily task or drive his car. The patient was treated by his physician for low back pain/sciatica on 10-JUL-2017 with an oral steroid medication without relief. The pain has worsened since he received treatment. No lab diagnostics or studies was performed. No additional information was provided. The outcome of the events was reported as unrecovered. The reporter considered the events to be significant disability or incapacity.
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Sciatica
Clinical narrative: Information was received from a pharmacist, referring to a 69 year old male patient. On 07-JUN-2017, at an unspecified pharmacy, the patient was administered reconstituted ZOSTAVAX vial 19400 PFU, PNEUMOVAX23 and sterile diluent in the right arm for prophylaxis (product use issue). On approximately 12-JUN-2017 (reported as "5 days later"), the patient developed constant pain in the right buttocks that radiated down his right leg and was incapacitated for 2 weeks. The patient remained in constant pain and he was not able to complete his normal daily task or drive his car. The patient was treated by his physician for low back pain/sciatica on 10-JUL-2017 with an oral steroid medication without relief. The pain has worsened since he received treatment. No lab diagnostics or studies was performed. No additional information was provided. The outcome of the events was reported as unrecovered. The reporter considered the events to be significant disability or incapacity.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report received from the physician referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The physician reported that on an unknown date, an unspecified patient was administered a dose of VARIVAX (lot and expiry date not reported) subcutaneously on an unspecified date, that had been reconstituted using an unspecified brand of Sterile Water (product preparation error). No adverse effects reported. Additional information is not possible as consent to be contact is not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Neck pain
Clinical narrative: This spontaneous report as received from a 49 year old female consumer refers to herself. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU by an unspecified pharmacist two weeks ago (product circular # uspi-v211-i-fro-1703r020) (dose, frequency, route, lot # and expiry date were not reported). On an unknown date the patient experienced redness but not swelling at the injection site for the first three days. At an unspecified date, the patient began to experience pain in her head, at the back of her neck "like when you sleep in a bad position". The pain is still being experienced at the time of this report. The patient has not sought medical attention for the pain. The outcome of the events were unknown. Causality assessment was not provided. No further information provided. No PQC filed. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 16 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. In July 2016, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (route of administration, lot number and expiration date were unknown). Then, next also, on 30-APR-2017, the patient was vaccinated with the second dose of GARDASIL 9 via intramuscular route for prophylaxis (lot number and expiration date were unknown).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 64 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 03-JUL-2017, the patient was vaccinated with ZOSTAVAX, lot # N009167 and expiration date 02-FEB-2018, (dose, route and anatomical location were not reported), for prophylaxis. No other suspect or concomitant therapies were reported. On an unknown date in 2017, the patient developed a red raised and warm to touch "area" at the injection site. The patient was treated with BENADRYL and with "cold compresses". At the time of reporting, the outcome of injection site erythema, injection site reaction and injection site warmth was unknown, and, the reporter did not assess the causal relationship between the injection site erythema, injection site reaction and injection site warmth with ZOSTAVAX.
Sex: U
Vaccine: HEP, HIBV, HPV9, MMR, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient may have received an improperly stored dose of one of the following vaccines: ROTATEQ lot # M044395, expiration date 31-MAY-2018, oral for prophylaxis (dose and frequency were not reported), RECOMBIVAX HB lot # L045117, expiration date 06-OCT-2018 for prophylaxis (dose, frequency and route of administration were not reported), M-M-R II lot # M034856, expiration date 27-JUL-2018 for prophylaxis (dose, frequency and route of administration were not reported), and GARDASIL 9 lot # M020103, expiration date 15-FEB-2018 for prophylaxis (dose, frequency and route of administration were not reported) or PEDVAXHIB  lot # reported as M046133 and expiration date reported as 26-SEP-2019 for an unknown indication (dose, frequency, route of administration were not reported). No adverse effect reported. It was reported that on an unspecified date, the vaccines were exposed to a temperature between 47 Farentheit degrees and 77 Farentheit degrees for 27 hours. The certified medical assistant reported that there was no previous temperature excursion. The call was placed because of a Digital Data logger report.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist referring to a currently 22 years old male patient. None concomitant medication, pertinent medical history nor drug reaction/ allergy was reported. On 18-APR-1996 and on 15-JUN-1999, the patient was vaccinated with the first and second dose respectively of M-M-R II (lot number, expiration dates, dose and route were not provided) for prophylaxis. On an unknown date, when titers were drawn for nursing school entrance, the patient showed no immunity against measles, mumps and rubella. The outcome of measles antibody negative, rubella antibody negative and mumps antibody test negative was reported as not recovered / not resolved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Medical Assistant  referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (strength, dose, frequency) lot # M038728 with expiration date of 25-APR-2018 and lot # M041184 with expiration date 31-MAY-2018, orally for prophylaxis. No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 16 and 32 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA008773: US-009507513-1707USA008774:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified patients of unknown age and gender. Their medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, an unspecified number of patients received improperly stored doses of PROQUAD (lot # M042501-valid, expiration date 17-APR-2018) (dose and route unknown) for prophylaxis (incorrect product storage. No adverse effects were reported. Temperature was reported as 15 degrees Fahrenheit (F) to 46 degrees F (15.3 degrees F) for a time frame of 40 minutes. Previous temperature excursion was 15 degrees F to 46 degrees F (15 degrees F) for 3 hours and this was reported as a data logger. This is one of the multiple reports from the same reporter (US-009507513-1707USA008649 and US-009507513-1707USA008650). Additional information has been requested.; Sender's Comments: US-009507513-1707USA008649: US-009507513-1707USA008650:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017,  the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot N002720, expiration date 12-MAY-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 32°F to 35°F for 1 hour. There was no temperature excursion. The call was made because there was a "data logger".  No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1707USA008817: US-009507513-1707USA008818: US-009507513-1707USA008861: US-009507513-1707USA008862: US-009507513-1707USA008793: US-009507513-1707USA008819: US-009507513-1707USA008820: US-009507513-1707USA008821: US-009507513-1707USA008838: US-009507513-1707USA008863: US-009507513-1707USA008864: US-009507513-1707USA008794: US-009507513-1707USA008795: US-009507513-1707USA008822: US-009507513-1707USA008823: US-009507513-1707USA008839: US-009507513-1707USA008865: US-009507513-1707USA008866: US-009507513-1707USA008824: US-009507513-1707USA008825: US-009507513-1707USA008840: US-009507513-1707USA008867: US-009507513-1707USA008868: US-009507513-1707USA008869: US-009507513-1707USA008796: US-009507513-1707USA008827: US-009507513-1707USA008841: US-009507513-1707USA008870: US-009507513-1707USA008797: US-009507513-1707USA008828: US-009507513-1707USA008829: US-009507513-1707USA008830: US-009507513-1707USA008842: US-009507513-1707USA008843: US-009507513-1707USA008798: US-009507513-1707USA008799: US-009507513-1707USA008831: US-009507513-1707USA008832: US-009507513-1707USA008844: US-009507513-1707USA008800: US-009507513-1707USA008833: US-009507513-1707USA008801: US-009507513-1707USA008802: US-009507513-1707USA008845: US-009507513-1707USA008846: US-009507513-1707USA008803: US-009507513-1707USA008804: US-009507513-1707USA008834: US-009507513-1707USA008835: US-009507513-1707USA008847: US-009507513-1707USA008848: US-009507513-1707USA008805: US-009507513-1707USA008806: US-009507513-1707USA008849: US-009507513-1707USA008850: US-009507513-1707USA008789: US-009507513-1707USA008807: US-009507513-1707USA008808: US-009507513-1707USA008851: US-009507513-1707USA008852: US-009507513-1707USA008809: US-009507513-1707USA008810: US-009507513-1707USA008853: US-009507513-1707USA008854: US-009507513-1707USA008790: US-009507513-1707USA008811: US-009507513-1707USA008812: US-009507513-1707USA008836: US-009507513-1707USA008855.
Age: 19.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a 19 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-JUN-2017, the patient was inadvertently vaccinated with a dose of PROQUAD lot # N000336 with an expiration date on 03-JUN-2018 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 17 year old female patient. The patient's medical history and concurrent conditions were not reported. The patient was given a shot of GARDASIL 9 and also given a second shot of MENVEO (reported as "MENZEO") concomitantly. After a minute, the patient "became dizzy and lightheaded". The physician asked the patient lay down, which helped her to feel better (recovering). Causality was not provided. Product quality complaint (PQC) was not involved. No additional adverse events have been reported. No further information has been provided. Additional information is not expected since there was no consent to contact the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash generalised
Clinical narrative: Information was received from a pharmacist concerning a 62 year old female patient with no allergies. No other information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was administered a dose of ZOSTAVAX subcutaneously (lot number and expiration date unknown). The pharmacist reported that the patient has had "a localized rash on her arm which lasted for 2 weeks" (specific dates unknown). It was not specified which arm the rash occurred on. The patient was treated with an unknown dose of clindamycin "for 10 days (unknown dates) after the rash started," and the patient then started treatment with an unknown dose of sulfamethoxazole (+) trimethoprim (BACTRIM) "yesterday" (28-JUN-2017), "after the treatment with clindamycin stopped." The pharmacist reported that the patient now has an "unspecified rash all over her body" after starting treatment with sulfamethoxazole (+) trimethoprim (BACTRIM), and it is unknown if the rash in "shingles." As of 29-JUN-2017, the patient was still not recovered and it is unknown if any labs or diagnostics were performed. No additional information was available. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Skin reaction
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous for prophylaxis (lot #, expiration date, dose and site of administration was not reported). On an unknown date, the patient experienced dermatological reaction to the vaccination. The pharmacist advised the patient to consult a doctor for treatment. The patient received an unspecified treatment. The outcome of dermatological reaction was unknown. The reporter considered dermatological reaction to be related to ZOSTAVAX.