chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: YF
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: 4:30 pm Dull headache. 02/11/2017: AM Sore arm at injection site. PM: Progressively worsening elbow and shoulder stiffness/soreness with continued headache. 02/12/2017: PM onset of neck stiffness with continued left arm soreness/stiffness and dull headache. 02/13/2015: 11 am On set of stiff left wrist. Difficulty with typing with left hand. Worsening left arm stiffness/soreness and shooting pain down left arm. PM onset of pins and needles sensation in left hand and fingers. 02/14/15: Continued headache, left arm stiffness/soreness and tingling sensation down left arm, hand and finger tips. Neck pain worse when looking down.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, X-ray limb normal
Clinical narrative: Have had terrible shoulder pain in left deltoid since date and time of shot. Have seen an orthopedic surgeon and had negative x-ray, however will be getting an MRI as shoulder pain has not subsided and on some days is worse than others.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received on 17-JAN-2017 from a registered nurse who reported that on 13-JAN-2017, a 14-year-old patient (gender unknown) was inadvertently administered a dose of PROQUAD (Route, site of administration, Lot number and expiration date were not reported).  No adverse effects were reported. No further information was provided. 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 concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid, (strength and dose were not reported) administered orally (lot # M029252, expiration date 14-MAR-2018) for prophylaxis. According to the reporter, ROTATEQ doses were exposed to the following temperatures excursions: 1 hour and 50 minutes between >0 degrees Celsius (C) and <2C, and 3 hours and 49 minutes between >0C and <2C. No adverse effects were reported. A digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1702USA005707: US-009507513-1702USA005576.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA injection (strength and dose were not reported) (lot # M027879, expiration date 24-JAN-2018) for prophylaxis. According to the reporter, VAQTA doses were exposed to the following temperatures excursions: 1 hour and 50 minutes between >0 degrees Celsius (C) and <2C, and 3 hours and 49 minutes between >0C and <2C. No adverse effects were reported. A digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005576: US-009507513-1702USA005706:
Sex: U
Vaccine: PNC13
Symptoms: Adverse reaction, Incorrect product storage
Clinical narrative: This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 4th of 15 reports. A patient of an unspecified age, gender and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/drug/AE, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Adverse reaction, Incorrect product storage
Clinical narrative: This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 6th of 15 reports. A patient of an unspecified age, gender and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/drug/AE, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Adverse reaction, Incorrect product storage
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for 15 patients. This is the 7th of 15 reports.  A patient of unspecified gender, age and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/product/event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Adverse reaction, Incorrect product storage
Clinical narrative: This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 13th of 15 reports. A patient of an unspecified gender, age and race/ethnicity received PREVNAR 13 (Lot. N4385, expiry date 31Oct2017) on an unknown date, single dose, for immunization. Relevant medical history and concomitant medications were unknown. The vaccine was administered to this patient after a temperature excursion. On an unspecified date, the patient experienced severe reactions on arm. Clinical outcome was unknown at time of this report.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/drug/AE, different patient.
Age: 61.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable pharmacist through a Pfizer sales representative. A 62-year-old male patient received PREVNAR 13 at 0.5ml single dose for immunization via unspecified route of administration. Medical history included diabetes. On unknown date the patient experienced pneumonia and the patient was hospitalized for it. The outcome of the event was reported as recovered. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVNAR 13 in this patient cannot be excluded. Further information like causative agent and serotyping results is needed for a full medical assessment.
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is the second of two reports. A 65-year-old female patient of an unspecified race and ethnicity received PREVNAR 13 at single dose via an unspecified route of administration on an unspecified date for immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced rash on an unspecified date after the vaccination. Outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017063162 Same reporter/suspect product/event, different patient.
Age: 1.0
Sex: F
Vaccine: FLU4, HBHEPB, HEPA, MMR, VARCEL
Symptoms: Blister
Clinical narrative: Blisters on nose initially, spread to left eye and side of face.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast tenderness, Injection site erythema, Swelling
Clinical narrative: Patient stated she experienced swelling, tenderness radiating to the axilla and left breast, and redness about the size of a baseball radiating from the site if injection on the left deltoid. She stated that within 24 hours, the swelling had mostly dissipated and the redness was the size of a half-dollar but the tenderness was still present under the left axilla and left breast region.
Age: 11.0
Sex: M
Vaccine: HPVX, MNQHIB
Symptoms: Abdominal pain upper, Dizziness, Dyspnoea, Migraine, Pyrexia
Clinical narrative: Fever ranging from 102-106.7 highest for several days vomit, migraine, stomach pain, dizziness, short of breath, running off. Sluggish.
Age: 11.0
Sex: M
Vaccine: HPVX, MNQHIB
Symptoms: Sluggishness, Vomiting
Clinical narrative: Fever ranging from 102-106.7 highest for several days vomit, migraine, stomach pain, dizziness, short of breath, running off. Sluggish.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Migraine
Clinical narrative: Migraine.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Consciousness fluctuating, Electroencephalogram normal, Joint dislocation, Loss of consciousness, Muscle strain
Clinical narrative: It started by me going in and out of consciousness for approximately 1 minute while brushing my teeth at the bathroom sink, and then losing consciousness for 5 hours, during which I had a seizure, dislocated my left shoulder, suffered a mid-back strain, and chewed up my tongue.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging brain normal, Seizure, Tongue biting
Clinical narrative: It started by me going in and out of consciousness for approximately 1 minute while brushing my teeth at the bathroom sink, and then losing consciousness for 5 hours, during which I had a seizure, dislocated my left shoulder, suffered a mid-back strain, and chewed up my tongue.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Disorientation, Dizziness, Erythema, Nausea, Rash macular
Clinical narrative: REDNESS/SPLOTCHINESS; LIGHTHEADED/DIZZINESS; NAUSEA; MILD DISORIENTATION.
Age: 1.83
Sex: F
Vaccine: HEPA, HIBV, PPV, VARCEL
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Vomiting started immediately after vaccinations and continued every 20-40 minutes for 3 hours until taking ZOFRAN.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Eye swelling, Pruritus generalised, Rash erythematous, Urticaria
Clinical narrative: Started wheezing, coughing red rash and itching over body, swelling around his eyes, eventually had hives on his trunk- s/p EPIPEN Jr dosingx1 plus BENADRYL 25 mg. Vomiting 4 hours later at home, so received a second dose of EPIPEN Jr, sent to local ED for further eval.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Vomiting, Wheezing
Clinical narrative: Started wheezing, coughing red rash and itching over body, swelling around his eyes, eventually had hives on his trunk- s/p EPIPEN Jr dosingx1 plus BENADRYL 25 mg. Vomiting 4 hours later at home, so received a second dose of EPIPEN Jr, sent to local ED for further eval.
Age: 20.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Broke out with chicken pox illness on 2/12/17.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, HEPA, HPV9
Symptoms: Dizziness, Pallor, Vision blurred
Clinical narrative: At approximately 1:30 PM patient was administered hepatitis A Dose #1 followed by HPV (GARDASIL 9) Dose #3. Noted patient became pale, complained of dizziness and blurred vision. Assisted to exam table, provided cooling measures, and apple juice, last food intake 10:00 AM today. Vital signs BP: 120/60, Respirations: 18, Pulse: 72, no respiratory or cardiac distress observed. Doctor informed, advised to have patient lay down another 30 minutes. Patient assessed, no further incident noted.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain
Clinical narrative: Severe abdominal pain and cramping for hours. From about 12:30pm to 2am. Self-administered activated charcoal around 2am.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: 3-5 minutes after MMR and VARIVAX administration, pt. developed hive-like rash on (L) check and (L) thigh around injection site. Gave 1/2 tsp. BENADRYL and MOTRIN in office.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Fist sized welt, itchy for 3 days.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: Pt. woke up in the morning feeling hot, redness to arm and some swelling.
Age: 1.75
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Patient due for DTAP, received TDAP.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Erythema, Flushing
Clinical narrative: Pt says her cheeks and chin were flushed and red. She also developed a cough that lasted 4 days. The redness persisted for 1-2 days reported 2/14/17.
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Deltoid area with red papular rash.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Headache, Pain
Clinical narrative: Arm redness, throbbing, no fever, and terrible headache.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed redness and swelling on her left upper arm after vaccination. Mother applied ice to the area. Over 48 hours redness and swelling resolved. No fever reported. Patient was able to use her arm as usual.
Age: 1.42
Sex: F
Vaccine: DTAP, FLU4, HIBV
Symptoms: Erythema, Swelling
Clinical narrative: Redness and minimally swollen. After receiving DTaP.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and induration to left deltoid post vaccine administration marked area as instructed by phone.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza, Vaccination site vesicles
Clinical narrative: Patient returns to the pharmacy after 1 week and shows shingles reaction in the vaccine area including vesicles. Pt. was referred to doctor who specified that it was shingles and prescribed antiviral medications. Patient is doing better but specified that then got the flu.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Paraesthesia
Clinical narrative: Tenderness, tingling, numbness from to top to bottom of LA.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Tenderness, tingling, numbness from to top to bottom of LA.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Pyrexia, Sepsis
Clinical narrative: Drop in BP and increased fever transported to ER by ambulance.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Dermatitis diaper, Diarrhoea, Emotional distress, Irritability
Clinical narrative: Patient developed fever to 102.8 9/10 and 9/11. Throat was red. Patient had diarrhea for 1 1/2 days. Patient continued to have poor appetite, intermittent fever, diaper rash, fussiness and being non consolable at night through 9/21/16.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pharyngeal erythema, Pyrexia
Clinical narrative: Patient developed fever to 102.8 9/10 and 9/11. Throat was red. Patient had diarrhea for 1 1/2 days. Patient continued to have poor appetite, intermittent fever, diaper rash, fussiness and being non consolable at night through 9/21/16.
Age: 28.0
Sex: M
Vaccine: FLUC4
Symptoms: Eyelid function disorder, Facial paralysis, Facial paresis
Clinical narrative: Case number PHHY2016US177032 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 654751) on 21 Dec 2016. This report refers to a 28 year old male patient. He had no reported medical history, current illness or concomitant medications. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported, previously reported as invalid: 13349211A) intramuscularly into the left arm on 19 Sep 2016. On 20 Sep 2016, the patient experienced difficulty to blink one eye which progressed to unilateral facial weakness. It was reported that the symptoms were consistent with Bell's palsy. Following the events the patient visited emergency room. The outcome of the events was reported as unknown. The events were reported as non-serious, but the event Bell palsy was upgraded as medically significant based on the information available in the NVS IME list. The causality of the events was not reported. Follow up information received from Quality assurance department on 01 Feb 2017: Batch number (13349211A) for the suspect vaccine (FLUCELVAX QUADRIVALENT) was confirmed to be invalid. Hence, the batch number was removed and the narrative was amended accordingly.
Age: 58.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood test, Disability, Guillain-Barre syndrome, Impaired work ability, Laboratory test
Clinical narrative: I got a workplace required flu shot at nursing home and got Guillain-Barre syndrome immediately next day and became 100% disabled and could not work consequently got terminated from work.
Age: 58.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Loss of employment, Nuclear magnetic resonance imaging, Scan
Clinical narrative: I got a workplace required flu shot at nursing home and got Guillain-Barre syndrome immediately next day and became 100% disabled and could not work consequently got terminated from work.
Age: 58.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood creatine phosphokinase normal, Burning sensation, Full blood count normal, Headache, Metabolic function test normal
Clinical narrative: I got a workplace required flu shot at nursing home and got Guillain-Barre syndrome immediately next day and became 100% disabled and could not work consequently got terminated from work.
Age: 58.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Muscular weakness, Myalgia, Pain, Pain in extremity
Clinical narrative: I got a workplace required flu shot at nursing home and got Guillain-Barre syndrome immediately next day and became 100% disabled and could not work consequently got terminated from work.
Age: 58.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Vomiting
Clinical narrative: I got a workplace required flu shot at nursing home and got Guillain-Barre syndrome immediately next day and became 100% disabled and could not work consequently got terminated from work.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Arthropathy, Blood test, Cataplexy, Disability, Eyelid function disorder
Clinical narrative: Case number PHHY2017US009689, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 661478) website on 23 Jan 2017. This report refers to a 53 years old female patient. Historical condition was not reported. Current condition included high BP (blood pressure) and sleep apnea. Concomitant medications included metoprolol. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) on 07 Nov 2013. After vaccination on 20 Dec 2013, the patient experienced episodes of eyes closing, which happened for few times and later episodes of collapsing, knee buckling, falling to ground or face on table if sitting especially when laughed. Following the events the patient visited emergency room/urgent care. The patient was diagnosed with narcolepsy with cataplexy by the neurologist and director of sleep center on an unknown date. The patient underwent two sleep studies, observations, blood work and one sleep study with second day scheduled naps and observations on an unknown date. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as permanent disability and causality was not reported. The Quality Assurance department confirmed that the initially reported batch number 66521011610 was not valid for any of Novartis legacy vaccine. Following an internal review done on 04 Feb 2017, it was identified that reported batch number does not belong to any Novartis legacy vaccine as confirmed by product quality assurance team (PTC). Hence, case PHHY2017US009689 will be deactivated.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Fall, Muscular weakness, Narcolepsy, Sleep study, Syncope
Clinical narrative: Case number PHHY2017US009689, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 661478) website on 23 Jan 2017. This report refers to a 53 years old female patient. Historical condition was not reported. Current condition included high BP (blood pressure) and sleep apnea. Concomitant medications included metoprolol. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) on 07 Nov 2013. After vaccination on 20 Dec 2013, the patient experienced episodes of eyes closing, which happened for few times and later episodes of collapsing, knee buckling, falling to ground or face on table if sitting especially when laughed. Following the events the patient visited emergency room/urgent care. The patient was diagnosed with narcolepsy with cataplexy by the neurologist and director of sleep center on an unknown date. The patient underwent two sleep studies, observations, blood work and one sleep study with second day scheduled naps and observations on an unknown date. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as permanent disability and causality was not reported. The Quality Assurance department confirmed that the initially reported batch number 66521011610 was not valid for any of Novartis legacy vaccine. Following an internal review done on 04 Feb 2017, it was identified that reported batch number does not belong to any Novartis legacy vaccine as confirmed by product quality assurance team (PTC). Hence, case PHHY2017US009689 will be deactivated.
Age: 49.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Arthralgia, Bone pain, Headache, Pain assessment, Sleep disorder
Clinical narrative: Case number PHHY2017US023349 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 662462) website on 23 Jan 2017. This report refers to a 49 year old female patient. Prior vaccination history included patient received unspecified vaccine with no side effects. Medical history was reported as none. Concomitant medications included anastrozole, SYNTHROID, Vitamin D and vitamin B complex. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) on 12 Oct 2016. The patient was also vaccinated with PREVNAR 13 (other manufacturer, batch number: not reported) on 12 Oct 2016. After vaccination on 13 Oct 2016, the patient experienced severe bone pain and joint pain, headache and reported that woke up the patient. The patient was treated with ibuprofen and reported that the pain went from 8 to 5 on the pain scale of 1 to 10. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the events bone pain and arthralgia was upgraded to (medically significant) based on the information available in the source document.
Sex: F
Vaccine: TTOX
Symptoms: Hypersensitivity
Clinical narrative: Initial unsolicited report received from a physician via Pfizer under reference number 2016464455 on 03 February 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, dose, route and site of administration were not reported) on unspecified date. Patient's medical history and concomitant medications were not reported. On unspecified date, following the vaccination the patient had allergies. Lab data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Blood test normal, Dizziness, Vertigo, Vomiting
Clinical narrative: Diagnosed with vertigo by ER Dr. They gave me meclizine and in an IV. They sent me home with prescriptions for both of these. I took the meclizine for 9 days and no help, went to Dr., he said to double up the meclizine and that I took twice at 50 mg each and woke up seeing double and still dizzy. I had 10 treatments of therapy for vertigo. Had an ENG and MRI done they found nothing!! After not working or driving for a month, it finally is much better. The Dr.'s have not come up with an answer, that is why I think it came from the flu shot!!!
Age: 69.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Diplopia, Dizziness, Electronystagmogram normal, Impaired driving ability, Impaired work ability
Clinical narrative: Diagnosed with vertigo by ER Dr. They gave me meclizine and in an IV. They sent me home with prescriptions for both of these. I took the meclizine for 9 days and no help, went to Dr., he said to double up the meclizine and that I took twice at 50 mg each and woke up seeing double and still dizzy. I had 10 treatments of therapy for vertigo. Had an ENG and MRI done they found nothing!! After not working or driving for a month, it finally is much better. The Dr.'s have not come up with an answer, that is why I think it came from the flu shot!!!
Age: 69.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Vertigo
Clinical narrative: Diagnosed with vertigo by ER Dr. They gave me meclizine and in an IV. They sent me home with prescriptions for both of these. I took the meclizine for 9 days and no help, went to Dr., he said to double up the meclizine and that I took twice at 50 mg each and woke up seeing double and still dizzy. I had 10 treatments of therapy for vertigo. Had an ENG and MRI done they found nothing!! After not working or driving for a month, it finally is much better. The Dr.'s have not come up with an answer, that is why I think it came from the flu shot!!!
Age: 67.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited report received from nurse on 03 Feb 2017. This case involves a 67-year-old female patient who was vaccinated with 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (batch number: UI689AA, expiry date: 26 Apr 2017) via intramuscular route in right deltoid on 17-Nov-2016. The patient's medical history and concomitant medications was not reported. On 17 Nov 2016, same day following vaccination, the patient had pain in right arm (> 2/2mo.). On an unspecified date, following vaccination, the patient had sleep disturbance due to persisting pain. The patient's laboratory test and corrective treatment was not reported. Patient was not recovered from pain (reported as pain persistent) and outcome of the event sleep disturbance was reported as unknown. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: Initial unsolicited report received from nurse on 03 Feb 2017. This case involves a 67-year-old female patient who was vaccinated with 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (batch number: UI689AA, expiry date: 26 Apr 2017) via intramuscular route in right deltoid on 17-Nov-2016. The patient's medical history and concomitant medications was not reported. On 17 Nov 2016, same day following vaccination, the patient had pain in right arm (> 2/2mo.). On an unspecified date, following vaccination, the patient had sleep disturbance due to persisting pain. The patient's laboratory test and corrective treatment was not reported. Patient was not recovered from pain (reported as pain persistent) and outcome of the event sleep disturbance was reported as unknown. List of documents held by sender: none.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product preparation error
Clinical narrative: This spontaneous report as received from a 60-year-old male patient refers to himself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-FEB-2017, the patient was vaccinated by his primary physician, with a dose of ZOSTAVAX injection (dose, frequency, route of administration, lot # and expiration date were not reported) for prevention of shingles. On 03-FEB-2017, the patient developed an injection site rash "the size of a half dollar" and the site was swollen, hard as a rock and hot to the touch. The rash was also itchy. On that day, the patient sought treatment from the physician who administered an unspecified antibiotic. On 04-FEB-2017, the patient felt the antibiotic was not working, went to the hospital emergency room and was hospitalized. The patient was diagnosed as having cellulitis and was administered unspecified intravenous antibiotics. Then, he was prescribed KEFLEX and BACTRIM antibiotics to take orally. At the time of the report, the patient was feeling better but still felt "tingly and weird". The outcome of cellulitis was reported as recovering. The relatedness between vaccination with ZOSTAVAX and cellulitis was not reported. Upon internal review, the event cellulitis was considered to be medically significant. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Feeling abnormal, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a 60-year-old male patient refers to himself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-FEB-2017, the patient was vaccinated by his primary physician, with a dose of ZOSTAVAX injection (dose, frequency, route of administration, lot # and expiration date were not reported) for prevention of shingles. On 03-FEB-2017, the patient developed an injection site rash "the size of a half dollar" and the site was swollen, hard as a rock and hot to the touch. The rash was also itchy. On that day, the patient sought treatment from the physician who administered an unspecified antibiotic. On 04-FEB-2017, the patient felt the antibiotic was not working, went to the hospital emergency room and was hospitalized. The patient was diagnosed as having cellulitis and was administered unspecified intravenous antibiotics. Then, he was prescribed KEFLEX and BACTRIM antibiotics to take orally. At the time of the report, the patient was feeling better but still felt "tingly and weird". The outcome of cellulitis was reported as recovering. The relatedness between vaccination with ZOSTAVAX and cellulitis was not reported. Upon internal review, the event cellulitis was considered to be medically significant. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Paraesthesia, Rash pruritic
Clinical narrative: This spontaneous report as received from a 60-year-old male patient refers to himself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-FEB-2017, the patient was vaccinated by his primary physician, with a dose of ZOSTAVAX injection (dose, frequency, route of administration, lot # and expiration date were not reported) for prevention of shingles. On 03-FEB-2017, the patient developed an injection site rash "the size of a half dollar" and the site was swollen, hard as a rock and hot to the touch. The rash was also itchy. On that day, the patient sought treatment from the physician who administered an unspecified antibiotic. On 04-FEB-2017, the patient felt the antibiotic was not working, went to the hospital emergency room and was hospitalized. The patient was diagnosed as having cellulitis and was administered unspecified intravenous antibiotics. Then, he was prescribed KEFLEX and BACTRIM antibiotics to take orally. At the time of the report, the patient was feeling better but still felt "tingly and weird". The outcome of cellulitis was reported as recovering. The relatedness between vaccination with ZOSTAVAX and cellulitis was not reported. Upon internal review, the event cellulitis was considered to be medically significant. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had a cellulitis-like reaction on the vaccinated arm - swelling, red, heat from shoulder to elbow. Patient also had flu-like symptoms - fever, chills, body aches.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Patient had a cellulitis-like reaction on the vaccinated arm - swelling, red, heat from shoulder to elbow. Patient also had flu-like symptoms - fever, chills, body aches.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient with area of spreading erythema +pain at site of where pneumococcal conjugate vaccine 13-valent IM was given 3 days prior.
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test, No adverse event, Occupational exposure to product
Clinical narrative: Information has been received from a female registered nurse of unknown age referring to herself. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the nurse was preparing a dose of ZOSTAVAX (dose, lot # and expiration date not reported), and when she was withdrawing reconstituted ZOSTAVAX, very small droplet squirted out and got onto her face near her left eye. ZOSTAVAX droplet did not get into the eye. The nurse immediately washed the area with soap and water. No adverse effects were reported. Follow-up information was received on 18-JAN-2017 from the registered nurse. The nurse reported that on an unknown date, the incident was a splash to the face/eye area while preparing ZOSTAVAX for intramuscular administration. The nurse was tested for varicella titre (results not provided). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 18 year old patient of unknown gender. The patient's concurrent conditions, medical histoy, historical drugs and concomitant medications were not reported. On 21-AUG-2016,  the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number and expiration date were not reported) and on 23-JAN-2017, was vaccinated with GARDASIL 9 intramuscularly (lot number M034780, expiration date 15-APR-2019, dose was not reported) both for prophylaxis. No adverse effects and no product quality complaint were involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gander. There was no information about the patients' concurrent condition, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M031574 with an expiration date 11-NOV-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported.  Administered doses of RECOMBIVAX HB experienced the temperature excursion with range over 32 and under 36 degrees Fahrenheit for 24 hours. A digital data logger was involved. There was no previous temperature excursions. Product quality complaint (PQC) was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to an unspecified patient of unknown age and gender. Information regarding the patient's medical history, drug reactions and concomitant therapies was not provided. On 30-JAN-2017,  the patient was vaccinated with an expired dose of ZOSTAVAX, (strength, dose, frequency, and route of administration were not provided),  lot # L039095 and expiration date 08-JAN-2017 for prophylaxis. No adverse effects were reported. Product quality complaint was not involved. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # reported as M064692 exp date 24-JAN-2018) (doses and route were not provided). The temperature of excursion was -14°C for 30 minutes in a range > -15°C but < -10°C. There was no previous temperature excursion. A data logger issue was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as the reporter does not want to be contacted.; Sender's Comments: US-009507513-1702USA006348:
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 75 year old male patient. His concurrent conditions included allergy to "IV contrast Dye" (with rash) and also rituximab allergy (manifested as itching). The patient had none known medical history. His concomitant therapies included aspirin (manufacturer unknown), ZETIA, PEPCID, vitamins (unspecified), ZOFRAN, ROXICODONE, COMPAZINE, VIAGRA and FLOMAX. On 24-JAN-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (intramuscularly, lot # M036728 exp 20-MAY-2018) (dose not provided) for prevention of pneumococcal disease. 12 hours after vaccination still on 24-JAN-2017, the patient experienced unspecified symptoms of allergic urticaria. On 26-JAN-2017, he sought medical treatment at the emergency department and was administered with BENADRYL, KENALOG cream. No lab diagnostic studies were performed. At the time of the report, the outcome of the allergic urticarial was recovering as the patient's symptoms were 99% resolved in an unspecified was by 28-JAN-2017. The medical assistant was requesting a lot check. The causal relationship between PNEUMOVAX 23 and the allergic urticarial was unknown. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA000374: US-009507513-1702USA002230: US-009507513-1702USA002231.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown dates, the patients was vaccinated with improperly stored doses of PEDVAXHIB, ROTATEQ and sterile diluent (dose, lot #, expiration date were not reported). No adverse event was reported. Administered doses of vaccines experienced the temperature excursion of 48.7 degrees Fahrenheit for 1 hour 30 minutes. Data logger was involved. There were no previous excursions reported. 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 medical assistant, concerning a multiple patients of an unknown gender and age. There were no concurrent conditions, medical history and concomitant medications reported. On an unspecified dates, the multiple patients could have been vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency and route not reported) lot # M037533 with expiration date of 17-MAY-2018. The medical assistant had no details about the excursion regarding the time and temperature but just stated that "the vaccines went out of range once." No adverse effects were reported. No product quality complaint (PQC) and data logger were involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA005697: US-009507513-1702USA005698.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse and refers to unspecified patients of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patients were vaccinated with a dose of improperly stored M-M-R II lot # M002419 and expiration date of 12-JAN-2018 and lot # reported as L02266 and expiration date 09-AUG-2018 (route of administration and anatomical location were not reported) for prophylaxis, which was stored at a lowest recorded temperature of 32 Fahrenheit (0 Celsius) and a highest temperature of 36 Fahrenheit (2.2 Celcius) for 34 days, the entire 24 hours each day, and a lowest recorded temperature of 46 Fahrenheit (7.7 Celsius) and a highest of 77 Fahrenheit (25 Celcius) for 24 hours. No previous temperature excursion was reported.  No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012928: US-009507513-1702USA002770: US-009507513-1702USA002768:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a practitioner nurse, concerning 15 patients of an unknown age and gender. There were no concurrent conditions, medical history and concomitant medications reported. On an unspecified dates in January 2017 (between 24-JAN-2017 and 28-JAN-2017), the patients were vaccinated with improperly stored doses of VARIVAX (dose, frequency and route were not reported), lot # M036292 with expiration date of 17-AUG-2017. No adverse effects were reported. The temperature excursion of the vaccines administered was greater than 5 Fahrenheit degrees but less than 14 Fahrenheit degrees, for a time frame of 26 hours. No product quality complaint was involved (PQC). Data logger was involved. No further information was provided. This is one of two reports received from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA000467:
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Colonoscopy, Crohn's disease, Endoscopy, Stool analysis
Clinical narrative: This spontaneous report was received from the patient's mother concerning her 13-year-old daughter. The patient's pertinent medical history, concurrent conditions, and concomitant therapies were not reported. The patient did not have known allergies or drug reactions. In 26-OCT-2016, the patient was vaccinated with the first dose of an unidentified Merck GARDASIL or GARDASIL 9; 0, 2 months and 6 months; intramuscular (IM) injection (Lot #, expiration date were not provided), for the prevention of human papillomavirus (HPV). The reporter stated that her daughter was diagnosed with Crohn's disease after receiving her initial injection of GARDASIL or GARDASIL 9 and because of it,  she sought medical attention from her pediatrician. On an unspecified date, a blood and fecal laboratory test were performed (results not provided). Later, on 05-DEC-2016, an endoscopy and a colonoscopy were performed (results not provided), and subsequently on 12-DEC-2016, an upper gastrointestinal (GI) exam was performed (results not provided). The reporter stated that her daughter was placed on treatment with PENTASA and prednisone (manufacturer unknown) (unspecified date, strengths, and doses) to treat Crohn's disease; and in addition, the patient was scheduled to start on infusion therapy with Remicade (manufacturer unknown) (unspecified dose, strength, and dates) also for the treatment of Crohn's disease. At the time of this report, the patient was recovering from the event of Crohn's disease. The causal relationship between the event of Crohn's disease and the therapy with GARDASIL or GARDASIL 9 was not provided. No product quality complaint was involved. Upon internal review, the event of Crohn's disease was determined to be medically significant. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: X-ray with contrast upper gastrointestinal tract
Clinical narrative: This spontaneous report was received from the patient's mother concerning her 13-year-old daughter. The patient's pertinent medical history, concurrent conditions, and concomitant therapies were not reported. The patient did not have known allergies or drug reactions. In 26-OCT-2016, the patient was vaccinated with the first dose of an unidentified Merck GARDASIL or GARDASIL 9; 0, 2 months and 6 months; intramuscular (IM) injection (Lot #, expiration date were not provided), for the prevention of human papillomavirus (HPV). The reporter stated that her daughter was diagnosed with Crohn's disease after receiving her initial injection of GARDASIL or GARDASIL 9 and because of it,  she sought medical attention from her pediatrician. On an unspecified date, a blood and fecal laboratory test were performed (results not provided). Later, on 05-DEC-2016, an endoscopy and a colonoscopy were performed (results not provided), and subsequently on 12-DEC-2016, an upper gastrointestinal (GI) exam was performed (results not provided). The reporter stated that her daughter was placed on treatment with PENTASA and prednisone (manufacturer unknown) (unspecified date, strengths, and doses) to treat Crohn's disease; and in addition, the patient was scheduled to start on infusion therapy with Remicade (manufacturer unknown) (unspecified dose, strength, and dates) also for the treatment of Crohn's disease. At the time of this report, the patient was recovering from the event of Crohn's disease. The causal relationship between the event of Crohn's disease and the therapy with GARDASIL or GARDASIL 9 was not provided. No product quality complaint was involved. Upon internal review, the event of Crohn's disease was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a license practical nurse concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (strength and dose were not reported) (lot # M032649, expiration date 11-NOV-2018) for prophylaxis. According to the reporter, RECOMBIVAX HB doses were exposed to the following temperatures excursions: 1 hour and 15 minutes between >0 degrees Celsius (C) and <2C, and 3 hours and 49 minutes between >0C and <2C. No adverse effects were reported. A digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA005707: US-009507513-1702USA005706.