chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Joint stiffness, Neuralgia
Clinical narrative: Second shot/injection took place at noon three weeks ago. At midnight following the second shot I woke up with very intense joint pain throughout my body paired with a fire-y more ?nerve-type? pain.    The symptoms described above subsided after about 6 hours then there was a lingering headache for the remainder of the day and my knees remained very sore. Both knees have had multiple surgeries and have signs of early arthritis due to sports injuries. It has been nearly three weeks and my knee joints continue to ache and be more stiff than prior to the side-effect event following the second shot.   I haven?t yet contacted my doctor hoping it will subside on its own, but wanted to report this in case others experience something similar.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood thyroid stimulating hormone, Blood thyroid stimulating hormone decreased, C-reactive protein, Chills
Clinical narrative: 3 hrs after I came down with a fever of 100, and body chills. By 2am I had busy aches.  Fatigue and really low energy started that following week. By the end of that week, I was feeling like a truck hit me. As of Monday April 5, I couldn't work. Dizziness and light headedness began. I want getting any better. Better vaccine I felt amazing, but I started to feel like death. I called my primary Dr first who ran bloodwork, then Dr took over from there.  The vaccine dumped my TSH levels fast, I had hit 30 and with having a total Thyroidectomy my levels need to be about 167 for me to feel my best. I've been stable for quite some time. I have had a drop before in the past but never felt so lathargic and sick as I have this time. I'm returning to work finally Monday May 3. It's been a long haul , getting better, and honestly I was scared to get the vaccine not knowing how my system would react due to having autoimmune diseases. I guess I found out the hard way.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Full blood count, Impaired work ability, Metabolic function test
Clinical narrative: 3 hrs after I came down with a fever of 100, and body chills. By 2am I had busy aches.  Fatigue and really low energy started that following week. By the end of that week, I was feeling like a truck hit me. As of Monday April 5, I couldn't work. Dizziness and light headedness began. I want getting any better. Better vaccine I felt amazing, but I started to feel like death. I called my primary Dr first who ran bloodwork, then Dr took over from there.  The vaccine dumped my TSH levels fast, I had hit 30 and with having a total Thyroidectomy my levels need to be about 167 for me to feel my best. I've been stable for quite some time. I have had a drop before in the past but never felt so lathargic and sick as I have this time. I'm returning to work finally Monday May 3. It's been a long haul , getting better, and honestly I was scared to get the vaccine not knowing how my system would react due to having autoimmune diseases. I guess I found out the hard way.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: 3 hrs after I came down with a fever of 100, and body chills. By 2am I had busy aches.  Fatigue and really low energy started that following week. By the end of that week, I was feeling like a truck hit me. As of Monday April 5, I couldn't work. Dizziness and light headedness began. I want getting any better. Better vaccine I felt amazing, but I started to feel like death. I called my primary Dr first who ran bloodwork, then Dr took over from there.  The vaccine dumped my TSH levels fast, I had hit 30 and with having a total Thyroidectomy my levels need to be about 167 for me to feel my best. I've been stable for quite some time. I have had a drop before in the past but never felt so lathargic and sick as I have this time. I'm returning to work finally Monday May 3. It's been a long haul , getting better, and honestly I was scared to get the vaccine not knowing how my system would react due to having autoimmune diseases. I guess I found out the hard way.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: 8 days after the vaccine, I developed a mildly itchy rash at the injection site, that last a few days.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dysuria, Influenza like illness, Nausea, Pain
Clinical narrative: flu like symptoms including nausea, chills and body aches but extreme pain urinating
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Vaccination site rash
Clinical narrative: Rash, itching at vaccination site
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Tremor
Clinical narrative: Extreme shaking chills, intense body aches all over pain 10/10, waves of nausea, headache, worst physical pain in lifetime
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Heart rate increased, Palpitations, Sleep disorder
Clinical narrative: Increased resting heart rate.  Noticed that my heart started to pump harder, first during an afternoon while sitting, no stress or agitation. The next morning, I woke up in the middle of the night due to some discomfort. I was at 100 BPm (normally at 60).
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Lip swelling, Pharyngeal swelling, Pruritus, Pyrexia
Clinical narrative: He received vaccine about 14:00.  he had no immediate symptoms such as urticaria, oral face, throat tongue swelling, red watery eyes, SOB, wheezing, CP, n/v/d. He states about two hours after receipt he developed generalized redness and hives with pruritis whole body except scalp. He recalls tongue lip and throat swelling. He also had fever of 102. He self treated with tylenol and went to ER. He reports he received a steroid shot and oral steroids . After 5-6 days the urticaria returned. he was seen in ER and treated with three medications (hydroxyzine, famotidine prednisone).  Per chart review, there is no immunization note. He was seen in ER at 18:44 on 09 MAR 21 day of anthrax vaccine receipt. HR is 104, sat 97%.  BP 117/58 Resp 18 and unlabored. Triage documented c/o head to toe erythema., Temp 99.5. Provider exam at 20:37 is normal, and he was diagnosed with post anthrax vaccination fever and instructed in self care with tylenol and motrin and discharged at 20:53.  There is a second ER visit 11 MAR at 0218 (32 hours post receipt anthrax #4). VS are HR 86, RR 16, sat 99% BP 120/73.  This not document c/o urticaria, swelling of lips and scrotum starting this morning (would be morning after ER #1 and estimate 15-18 hours after vaccine receipt). ER note states multiple erythematous wheals and hives to trunk and extremities, with focal edema to left anterior tibia, edema to scrotum and erythema across groin. He was treated with medrol dose pack, Zyrtec and  and solumedrol 125 mgs.  He reports symptoms are now resolved but continued to have outbreaks or urticaria until last week. He  is still taking hydroxyzine and famotidine (he does not know his medications and can only describe by pill color). There are instructions to taper off, which he has started.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Scrotal swelling, Swollen tongue, Urticaria, Vital signs measurement
Clinical narrative: He received vaccine about 14:00.  he had no immediate symptoms such as urticaria, oral face, throat tongue swelling, red watery eyes, SOB, wheezing, CP, n/v/d. He states about two hours after receipt he developed generalized redness and hives with pruritis whole body except scalp. He recalls tongue lip and throat swelling. He also had fever of 102. He self treated with tylenol and went to ER. He reports he received a steroid shot and oral steroids . After 5-6 days the urticaria returned. he was seen in ER and treated with three medications (hydroxyzine, famotidine prednisone).  Per chart review, there is no immunization note. He was seen in ER at 18:44 on 09 MAR 21 day of anthrax vaccine receipt. HR is 104, sat 97%.  BP 117/58 Resp 18 and unlabored. Triage documented c/o head to toe erythema., Temp 99.5. Provider exam at 20:37 is normal, and he was diagnosed with post anthrax vaccination fever and instructed in self care with tylenol and motrin and discharged at 20:53.  There is a second ER visit 11 MAR at 0218 (32 hours post receipt anthrax #4). VS are HR 86, RR 16, sat 99% BP 120/73.  This not document c/o urticaria, swelling of lips and scrotum starting this morning (would be morning after ER #1 and estimate 15-18 hours after vaccine receipt). ER note states multiple erythematous wheals and hives to trunk and extremities, with focal edema to left anterior tibia, edema to scrotum and erythema across groin. He was treated with medrol dose pack, Zyrtec and  and solumedrol 125 mgs.  He reports symptoms are now resolved but continued to have outbreaks or urticaria until last week. He  is still taking hydroxyzine and famotidine (he does not know his medications and can only describe by pill color). There are instructions to taper off, which he has started.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: PATIENT FAINTED WITHIN FEW MINUTES OF RECEICING THE VACCINE WHILE IN THE OBSERVATION AREA. I GRABBED THE PATIENT BEFORE HE FAINTED AND LAYED HIM ON THE FLOOR. HAD THE PATIENT SIT FOR ADDITIONAL 15 MINUTES FOR OBSERVATION, A TOTAL OF 35 MIN. HE FELT FINE AND LEFT THE STORE ON HIS OWN. PATIENT DID ADVISE THAT HE HAS A HISTORY OF FAINTING WHEN GIVING BLOOD.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pyrexia
Clinical narrative: Chills developed around midnight, fever at the time of chills 98.8F, later in the night 102.5. Still ongoing at 4am 04/29/21. Slight frontal headache and sore injection site.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted about 5 minutes after vaccination. Came to within one minute. Took blood pressure 125/76 pulse 64. Patient layed down for 5 minutes and then sat for 15.  He drank some gaterade.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Migraine, Synovial cyst
Clinical narrative: Migraines for both shots Second shot: Large, rapidly appearing Ganlion cyst in injection arm within 9 days.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Headache, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Pain
Clinical narrative: Fever of 102.2, chills, general soreness, fatigue
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paralysis
Clinical narrative: I'm paralyzed from my chest down!
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Body aches, headaches, treated with Aleve ; extreme fatigue- treated with sleep. Felt like I had a fever but I didn?t register over 99
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Anion gap, Aspartate aminotransferase normal, Bilirubin conjugated increased, Blood albumin normal, Blood bilirubin increased
Clinical narrative: Death Narrative:  Patient was admitted to facility from 1/11/2021 to 1/13/2021 for treatment of Covid 19 with symptoms of fatigue and poor oral intake. Admission was uneventful and follow-up notes post discharge from both Cardiology APRN and Primary Care Physician that the Patient was recovering well post admission. Patient received first of Covid Pfizer Vaccine on 4/2/2021 and second dose of Covid Pfizer Vaccine on 4/22/2021. Patient had been observed for 15 minutes after administration of each dose. No reaction was noted during the post vaccination observation period of either dose. Notice of death was received 5 days after second dose of Covid Vaccine from funeral home. There were no reports of an ADR occurring between observation period and death. There were no progress notes in patients chart between second Covid 19 Vaccine note 4/22/201 and death notice 4/27/2021. Cause of death is unknown at this time.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood chloride normal, Blood cholesterol normal, Blood creatinine increased, Blood glucose increased, Blood potassium normal
Clinical narrative: Death Narrative:  Patient was admitted to facility from 1/11/2021 to 1/13/2021 for treatment of Covid 19 with symptoms of fatigue and poor oral intake. Admission was uneventful and follow-up notes post discharge from both Cardiology APRN and Primary Care Physician that the Patient was recovering well post admission. Patient received first of Covid Pfizer Vaccine on 4/2/2021 and second dose of Covid Pfizer Vaccine on 4/22/2021. Patient had been observed for 15 minutes after administration of each dose. No reaction was noted during the post vaccination observation period of either dose. Notice of death was received 5 days after second dose of Covid Vaccine from funeral home. There were no reports of an ADR occurring between observation period and death. There were no progress notes in patients chart between second Covid 19 Vaccine note 4/22/201 and death notice 4/27/2021. Cause of death is unknown at this time.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood sodium normal, Blood triglycerides increased, Blood urea increased, Brain natriuretic peptide increased, COVID-19
Clinical narrative: Death Narrative:  Patient was admitted to facility from 1/11/2021 to 1/13/2021 for treatment of Covid 19 with symptoms of fatigue and poor oral intake. Admission was uneventful and follow-up notes post discharge from both Cardiology APRN and Primary Care Physician that the Patient was recovering well post admission. Patient received first of Covid Pfizer Vaccine on 4/2/2021 and second dose of Covid Pfizer Vaccine on 4/22/2021. Patient had been observed for 15 minutes after administration of each dose. No reaction was noted during the post vaccination observation period of either dose. Notice of death was received 5 days after second dose of Covid Vaccine from funeral home. There were no reports of an ADR occurring between observation period and death. There were no progress notes in patients chart between second Covid 19 Vaccine note 4/22/201 and death notice 4/27/2021. Cause of death is unknown at this time.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Death, EGFR status assay, Fatigue, Glycosylated haemoglobin increased, High density lipoprotein decreased
Clinical narrative: Death Narrative:  Patient was admitted to facility from 1/11/2021 to 1/13/2021 for treatment of Covid 19 with symptoms of fatigue and poor oral intake. Admission was uneventful and follow-up notes post discharge from both Cardiology APRN and Primary Care Physician that the Patient was recovering well post admission. Patient received first of Covid Pfizer Vaccine on 4/2/2021 and second dose of Covid Pfizer Vaccine on 4/22/2021. Patient had been observed for 15 minutes after administration of each dose. No reaction was noted during the post vaccination observation period of either dose. Notice of death was received 5 days after second dose of Covid Vaccine from funeral home. There were no reports of an ADR occurring between observation period and death. There were no progress notes in patients chart between second Covid 19 Vaccine note 4/22/201 and death notice 4/27/2021. Cause of death is unknown at this time.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Hypophagia, Low density lipoprotein normal, Vitamin D
Clinical narrative: Death Narrative:  Patient was admitted to facility from 1/11/2021 to 1/13/2021 for treatment of Covid 19 with symptoms of fatigue and poor oral intake. Admission was uneventful and follow-up notes post discharge from both Cardiology APRN and Primary Care Physician that the Patient was recovering well post admission. Patient received first of Covid Pfizer Vaccine on 4/2/2021 and second dose of Covid Pfizer Vaccine on 4/22/2021. Patient had been observed for 15 minutes after administration of each dose. No reaction was noted during the post vaccination observation period of either dose. Notice of death was received 5 days after second dose of Covid Vaccine from funeral home. There were no reports of an ADR occurring between observation period and death. There were no progress notes in patients chart between second Covid 19 Vaccine note 4/22/201 and death notice 4/27/2021. Cause of death is unknown at this time.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Death, Delusion, Hallucination
Clinical narrative: Death Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient was transferred to behavioral health unit at an outside nursing home on 2/15/21 after hospitalization for psychiatric evaluation on 1/29/21 w/subsequent Law for erratic behavior w/ delusions/hallucinations. Patient passed away on 4/12/21 at an outside facility with details surrounding death unknown. PMH significant for CKD, AAA, PVD, anemia, CAD, Dm, HTN, COPD, advanced age.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Death, Dyspnoea, Productive cough, Sputum discoloured
Clinical narrative: death Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient has PMH significant for neoplasm of liver, stage 4 esophageal adenocarcinoma congestive cardiomyopathy, AF, htn. Seen 3/22, per not "states that for the past three days he has had constant chest heaviness and shortness of breath along with productive cough with dark sputum." Discharged 3/24. Deceased 4/2/2021 however no notation or death certificate noted.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, Cardiac failure, Condition aggravated, Death
Clinical narrative: Death Narrative:  Patient was previously tested COVID-19 positive on 3/2/2021, but did not have any other predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was admitted with afib with RVR on 2/17/21 and was having a HFrEF exacerbation. HR was controlled during admission and he was discharged on 2/19/21. Patient was hospitalized 4 more times over the next two months for cardiac symptoms with last hospitalization occurring 4/12/21 for hypotension/tachycardia and decompensated heart failure. Patient never recovered and transitioned to hospice before passing on 4/16/21. Patient had a PMH significant for afib s/p DCCV on eliquis, CKD, HFpEF on home O2 2L, PMR on prednisone, known R pleural effusion, Covid PNA in 11/2020 and chronic foley
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, SARS-CoV-2 test positive, Tachycardia
Clinical narrative: Death Narrative:  Patient was previously tested COVID-19 positive on 3/2/2021, but did not have any other predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was admitted with afib with RVR on 2/17/21 and was having a HFrEF exacerbation. HR was controlled during admission and he was discharged on 2/19/21. Patient was hospitalized 4 more times over the next two months for cardiac symptoms with last hospitalization occurring 4/12/21 for hypotension/tachycardia and decompensated heart failure. Patient never recovered and transitioned to hospice before passing on 4/16/21. Patient had a PMH significant for afib s/p DCCV on eliquis, CKD, HFpEF on home O2 2L, PMR on prednisone, known R pleural effusion, Covid PNA in 11/2020 and chronic foley
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Death, Wheezing
Clinical narrative: Death Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug  event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 93 and receiving home based palliative care. On 3/30/21 his home nurse reported he was having bilateral lung wheezing. On 4/16/21 patient's wife stated he passed away at home after suffering an "asthma attack." PMH significant for dementia, malnutrition, reduced mobility, bedbound, Alzheimer's, DM, afib, CAD, NSTEMI
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for amyotrophic lateral sclerosis, AF, HTN. No notation regarding death, or cause of death. Patient deceased 4.16.21
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhagic stroke
Clinical narrative: HEMORRHAGIC STROKE; This spontaneous report received from a lawyer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021 (Within 24 hours after vaccination), the patient experienced a stroke and was hospitalized. On 13-MAR-2021, the patient was transferred to another hospital where she was diagnosed with a haemorrhagic stroke. Currently, the patient was admitted as inpatient rehabilitation center.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hemorrhagic stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: Medical Assessment Comment not required per standard operations procedure for legal case
Age: 7.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Patient has received a dose of GARDASIL 9 on 4/9/2021 for an indication not approved in the prescribing Information; Gardasil 9 administerd to 7 years old patient; This spontaneous report was received from a physician referring to a 7-year-old patient of unknown gender.  The patient's concurrent conditions included juvenile onset recurrent respiratory papillomatosis. The patient's medical history and concomitant medications were not reported.  On 09-APR-2021, the patient began a 3-dose vaccine series with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection (frequency, route of administration, anatomical location, lot number and expiration date were not reported) for an indication outside of the Prescribing Information and the vaccine was being administered to potentially decrease disease recurrence (juvenile onset recurrent respiratory papillomatosis). No further adverse events (AEs) reported, no further information provided.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Neurological symptom, Neuropathy peripheral
Clinical narrative: neuropathy; other serious neurological problems; balance problems; Information was received from a lawyer regarding the case in litigation and refers to a patient of unknown age and gender. The patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On or about 28-DEC-2013, patient was administered the zoster vaccine live (ZOSTAVAX) in a clinic. Subsequently, patient was treated by providers in for the following injuries resulting from patient's zoster vaccine live (ZOSTAVAX) use: neuropathy, balance problems, and other serious neurological problems. The outcome of the events was not reported. The events were considered to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the events of neuropathy and other serious neurological problems was determined to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 18-JAN-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 08-FEB-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 09-FEB-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 01-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 01-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 05-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 09-APR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 19-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 19-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 19-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 15-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 08-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 18-JAN-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270: