chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from nurse refers to a 12 years old female patient. In June of 2012 (reported as 2 months ago), the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported). No other co-suspects were reported. Concomitant medications included a total of 5 vaccines (unspecified) that she received "that day" (in June of 2012). Nurse informed that a patient came back for routine second dose of GARDASIL (dose, route and lot number not reported, date unspecified) and the patient's mother reported to the nurse that after the first dose (in June of 2012), her daughter "passed out and had what appeared to be a seizure". The patient did continue with her second dose of GARDASIL and seemed to do fine after the second dose. No treatment was given for the patient's events. It was reported that the patient did not seek medical attention. At the time of report, the patient was recovered. The relatedness for the patient's event was not reported for GARDASIL. Upon internal review, the patient's events of "passed out and had what appeared to be a seizure" were considered to be other important medical events. Additional information has been requested.
No adverse events known as of yet. Patient was under the age of 18 when she received the booster. Patient specifically requested Moderna vaccine but pharmacist at the time did not advise against it or possibly forgot to check age.
This spontaneous report as received from a medical assistant refers to 4 patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of  GARDASIL (lot # L040460 exp date 27-MAY-2017) (dose and route not reported). The temperature of excursion was 51 F for 144 hours. There was no previous temperature excursion. A data logger issue was reported. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007072: US-009507513-1702USA007073:
Patient ID: MRN:  Name:  Age: 67 y.o. Birthday:   Admit Date: 8/13/2022  1:16 PM Discharge Date:  8/15/2022 Unit:  Admitting Physician:  Discharge Physician: M.D.   Discharge Diagnosis: Principal Problem:   Syncope Active Problems:   COVID-19 virus infection   AKI (acute kidney injury)   B12 deficiency       HPI: "The patient is a 67 y.o. female with a history below admitted for Syncope. Pt came in with complaints of sudden loss of consciousness. States was sitting, 'felt woozy', then suddenly became unresponsive. Family there. Lasted 3 minutes or so. Nothing made better / worse. Was grey in color, diaphoretic, eyes glazed over. When pt came to, she states she had no confusion after. Has some headache now but otherwise no focal deficits. Eats little at baseline, and although has not had any resp symptoms, may have become dehydrated from poor po intake. Smokes daily. Does not want nicotine patch. No hx of stroke for her, but family hx present. Discussed cxr finding. Discussed with er and will admit ".   Hospital Course:  The patient was admitted to the hospital and was evaluated and treated per below.    The patient was admitted to Hospital telemetry which remained essentially unremarkable. Patient appears dehydrated with a serum creatinine on admission up to 1.4. Was treated with IV fluid hydration and creatinine trended down to 1.1. She was feeling markedly better. She remains off all her blood pressure medications and blood pressure remained on the low side but significantly improved. Patient appetite improved as well along with her by mouth fluid intake. CT of the head showed no acute findings and MRI showed no acute changes. Carotid duplex showed mild plaque but no stenosis and echocardiogram was done Showing no cardiac source of emboli noted. Was found to have B12 deficiency and started on replacement treatment. For discharge per neurology to follow up outpatient.   Physical Exam on the Date of Discharge: Stable and improved.      Consults:   IP CONSULT TO STROKE NURSE NAVIGATOR IP CONSULT TO NEUROLOGY IP CONSULT TO SOCIAL WORK   Significant Diagnostic Studies:    labs, radiology, and cardiac graphics: per chart.     Disposition:  home   Discharge Condition:  good
Per mom - patient developed fever + rash, which increased every day. Vaccine date 6-28-15. Evaluated on 6/27/2015 - noted to be very hot and well demarcated red patch - started on cefdinir 10 day course. Fever 104 - cellulitis (L) upper arm seen by PCP on 6/29/15 - area on (L) upper arm rash fading.
Patient felt faint while standing and singing during church. Passed out for a few seconds. Skin was hot and sweaty. Removed his jacket, gave him water and fed him a donut. Patient recovered after about 10 minutes.
This is a spontaneous report from a non-contactable consumer (patient's mother). A 20-year-old female patient received TRUMENBA, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date (reported as Apr) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received a dose of meningococcal group b rlp2086 on an unspecified date reported as 'Apr' on her sick doctor's visit, her physical was scheduled 2 days after her sick visit so instead of coming back 2 days later doctor has done a physical and one dose of meningococcal group b rlp2086 was administered to the patient at the time of the visit. However for unknown reason when the patient's mother reached out to the doctor's office few months later as her daughter needed some forms for college. She was told by doctor's office that they do not have a record of her daughter receiving meningococcal group b rlp2086 in Apr or having physical on that day. The consumer stated that her daughter remember it because she even had her arm hurting. The outcome of the event of arm hurting was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.
patient was administered vaccine which had undergone several temperature excursions.; No adverse event; patient was administered vaccine which had undergone several temperature excursions.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.), PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.) and NO ADVERSE EVENT (No adverse event) in a 25-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19. Patient had no allergies to medications, food, and other products.     On 25-Sep-2022 at 12:33 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 25-Sep-2022 at 12:33 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.), PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.).    Concomitant product use was not provided by the reporter.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid. It was reported that the vaccines had undergone several temperature excursions in August 2022. Vials were moved from freezer to refrigerator on 7SEP2022 It was reported that Refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department made aware of the situation.  The vial size was reported as 5.5ml.  Treatment information was not provided.
This spontaneous prospective pregnancy report as received from a consumer refers to his 28 year old wife with no pertinent medical history and drug reactions or allergies who in 2008, was vaccinated with the first dose of M-M-R II (dose, route and lot number not reported). For unspecified reason, titer was drawn for this patient on 15-JUL-2014 and titer measles was borderline and patient received another dose of M-M-R II (dose, route and lot number not reported) on 22-JUL-2014 at health department. On 05-AUG-2014, the patient's wife found out to be pregnant. At the time of the report, the patient had not recovered from the experience. The patient did not see medical attention. The relatedness for titer was drawn for the patient on 15-JUL-2014 and titer for measles was borderline and M-M-R II was unknown. Additional information is not expected.
Information has been received from a consumer, regarding her 20 year old granddaughter with no pertinent medical history, who on an unknown date was vaccinated IM with the second dose of GARDASIL (lot # not provided). There was no concomitant medication. After the vaccination, her granddaughter fainted. She recovered and "was fine" before she left the office. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007.  Initial and follow up information has been received from a grandmother and mother, regarding their 20 year old daughter/grandaughter with no pertinent medical history, who on an unknown date was vaccinated IM with the first dose (previously reported as second dose by the grandmother) of GARDASIL (lot # not provided).  There was no concomitant medication.  After the vaccination the grandmother reported her grandaughter fainted.  She recovered and "was fine" before she left the office.  Follow up information from the mother indicated that this was the first time her daughter had ever passed out.  She commented that the grandmother had called because she was concerned about her grandaughter receiving further doses of the vaccine.  However, she added that her daughter proceeded to receive both the second and the third dose of GARDASIL (dates and lot # not provided), with no complication.  Additional information has been requested.
Febrile seizure-temp 101 at time of hospitalization. Mom has a history of febrile seizures.
Administration of Menveo reconstituted using sterile water instead of the MenCYW-135 liquid conjugate vaccine component; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA766A, expiry date 31-DEC-2023) for prophylaxis.   On 10-MAY-2023, the patient received Menveo. On 10-MAY-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Administration of Menveo reconstituted using sterile water instead of the MenCYW-135 liquid conjugate vaccine component). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 10-MAY-2023 The nurse reported that the administration of Menveo reconstituted using sterile water instead of the MenCYW-135 liquid conjugate vaccine component.  The healthcare professional (HCP) asked how to proceed with this patient.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received Menveo which was reconstituted using sterile water instead of the MenCYW-135 liquid conjugate vaccine component, which led to wrong solution used in drug reconstitution.
5/2/08 around 2200 c/o aching, chills, and generalized aching all over body. Took Motrin 600 mg that night. 5/3/08 used compress to injection site, aching, took Tylenol 1000 mg and then started taking Benadryl 10 p.m. 5/4/08 felt better continued Tylenol and Benadryl. c/o change in voice, sore throat. Temp 98.4. Going to see her physician.
After the first, I could hardly walk!; This case was reported by a consumer via interactive digital media and described the occurrence of walking difficulty in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced walking difficulty. On an unknown date, the outcome of the walking difficulty was unknown.   It was unknown if the reporter considered the walking difficulty to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and he/she could hardly walk. The patient asked did anyone had a bad reaction from the shot.   The patient was afraid to get the second one. Additional supportive information: The follow-up would not possible as no contact details were available.
Small rash on legs and ankles; Hives; Raised red rash on leg, arm and waist; Fatigue; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), URTICARIA (Hives), RASH PAPULAR (Raised red rash on leg, arm and waist), RASH (Small rash on legs and ankles) and FATIGUE (Fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN (Soreness) and FATIGUE (Fatigue). On 23-Jan-2021, the patient experienced URTICARIA (Hives) and RASH PAPULAR (Raised red rash on leg, arm and waist). On 05-Feb-2021, the patient experienced RASH (Small rash on legs and ankles). On 22-Jan-2021, PAIN (Soreness) and FATIGUE (Fatigue) had resolved. On 26-Jan-2021, URTICARIA (Hives) had resolved, RASH PAPULAR (Raised red rash on leg, arm and waist) outcome was unknown. At the time of the report, RASH (Small rash on legs and ankles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Claritin. No relevant concomitant medications reported.
ErythemaMultiform Redness, swelling, itching, pain over left deltoid began 2 days after injection and worsening since that time; upon exam 12/30/2020, 4x5cm area of erythema, induration and heat over left deltoid.
approx 3 hrs p/vax pt devel fever to 103; severe h/a, vomiting extreme lethargy;
Patient became symptomatic mid-November with head pain and extremity weakness. Patient was admitted on 11/20/09 and discharged 11/23/09 with a diagnosis of extremity paresthesias and weakness. Patient readmitted on 12/2-10/09 because of persistent lower extremity weakness, numbness, tingling and upper extremity weakness.
1. Chills and shaking starting at 1:30am 2. Nausea 3. Hallucinogenic fitful dreams 4. Didn?t sleep at all.  5. Almost fell over going to the toilet.
Information has been received from a registered pharmacist concerning a female patient who is also her student with an allergy to eggs who was vaccinated with a dose of PNEUMOVAX vaccine. The pharmacist reported that the patient experienced and allergic reaction after PNEUMOVAX vaccine was given. The pharmacist stated she did not want to report this case because she was not certain the patient was certain it was an allergic reaction. It is unknown if the patient sought medical attention. No further information is available.
After eight hours from the time of the flu shot, I experienced a rapid heat beat and increased resperation.  Normal sitting pulse for me is 70 to 80 per minute, I was experiencing a pulse rate from 135 to 145 per minute.  Normal sittting resperation is 12 per minute, resperation increased to 21 per minute.  I have a persciption for Trazadone, I took a 20 mg tablet, at that point pulse was reduced to 90 beats per minute and resperation was reduced to 14 per minute, after 20 minutes after taking trazadone.  I fell a sleep after that.  12 hours later I woke up, feeling okay, skin was iching the night before as well.
Large local reaction to left thigh and no systemic signs all within 24 hours of vaccine.
Bright red rash both eyes, undereyes started to extend to temple region as well. Was increasing quickly took 3 H2 blockers and it started to decrease over several hour. Took another zyrtec for redness that remained.  In am. Redness was gone but undereyes looked bruised x 2days
Left arm became itchy/arm itches like crazy; left arm bright red; swollen at the injection site; vaccination site warmth; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), VACCINATION SITE PRURITUS (Left arm became itchy/arm itches like crazy), VACCINATION SITE ERYTHEMA (left arm bright red), VACCINATION SITE SWELLING (swollen at the injection site) and VACCINATION SITE WARMTH (vaccination site warmth) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included Hypertension. Concomitant products included SPIRONOLACTONE (SPIRONOLACTONE A L), OLMESARTAN MEDOXOMIL (OLMESARTAN [OLMESARTAN MEDOXOMIL]) and BUPROPION HYDROCHLORIDE (BUPROPION BETA) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 20-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Left arm became itchy/arm itches like crazy), VACCINATION SITE ERYTHEMA (left arm bright red), VACCINATION SITE SWELLING (swollen at the injection site) and VACCINATION SITE WARMTH (vaccination site warmth). At the time of the report, VACCINATION SITE PAIN (sore arm) had resolved and VACCINATION SITE PRURITUS (Left arm became itchy/arm itches like crazy), VACCINATION SITE ERYTHEMA (left arm bright red), VACCINATION SITE SWELLING (swollen at the injection site) and VACCINATION SITE WARMTH (vaccination site warmth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.   Reporter did not allow further contact
Patient presented to ED with rash that started 1 week prior, shortly after receiving 2nd COVID vaccine. Given steroid, pepcid, benadryl and some fluids in ED then discharged on 5 days benadryl + prednisone
Patient called 2/18/11 complaining of muscle soreness in shoulder where shot was given that seems to have gradually worsened. No swelling, no redness, no itching, no warmth to touch, but can't lift arm over head.
Fever, chills, body aches, headache, nausea, fatigue, sore injection site
Patient had hives, respiratory distress (ex. wheezing, stridor), throat constriction, flushing/sweating. Sensation of panic, itchiness, skin turning red all over. Clear lungs throughout, red lacy rash across entire back and both arms. Slight cough, smoked last cigarette early in the AM. Extensive history of severe allergies and was carrying her EpiPen. Given Benadryl 25 mg PO 21 minutes after vaccine. Patient left AMA, insisted on leaving stating husband was waiting for her. Cancelled 2nd dose; made appointment for Johnson & Johnson vaccine.
Test Name: COVID/Result: positive; Test Name: COVID/Result: positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), as DOSE 1, SINGLE (Batch/Lot number: unknown), as DOSE 2, SINGLE (Batch/Lot number: unknown) and as DOSE 3 (BOOSTER), SINGLE (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Breo for Asthma, notes: History, Other medical conditions: No, she has asthma. She used Breo for years, but now is using Ventolin as needed.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jul2022, outcome "unknown" and all described as "Test Name: COVID/Result: positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Positive, notes: Test Name (free text): Covid   Result Unstructured Data (free text): Result: positive; Unit: Not Provided; Weight: (unspecified date) 152-153 lbs, notes: Patient weight: 152-153 pounds. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt is a 24 y/o otherwise healthy presented to the ER with complaint of 12 hours of chest pain. He was in his usual state of health until he started experiencing diffuse "numbness", which is how he feels when he is getting sick. Throughout the day the numbness became more like myalgias and he developed a non focal HA. He went to bed at his normal time then woke early morning with chest pressure that radiated to his back. He tried multiple times to fall back asleep. However he was never able to sleep longer than 45min 2/2 pain. Chest pain is worse when lying flat. He presetned to the ER today after he started to feel SOB in addition  to the chest pain. He denies URI symptoms. He traveled on 15JAN16 then returned 15FEB16. He received smallpox vaccine (right shoulder) 2wks prior.
I was dizzy and my head felt really large, and I didn't feel well, and I was tired. I was not able to keep anything down. I took a home COVID test and it was positive. I had a low-grade fever, and I slept a lot.  I called my doctor and got paxlovid.
Information has been received from a nurse concerning a 4 to 6 year old male who on approximately 01-APR-2008 was vaccinated with VARIVAX (Merck). Concomitant therapy included other unspecified vaccines given on the same day. The nurse included other unspecified vaccines given on the same day. The nurse reported that the patient who was vaccinated with second dose of VARIVAX (Merck) developed hives immediately post vaccination. The patient was observed and monitored at the office. At the time of the report the patient had recovered. Additional information has been requested.
Seizure - first one was 3 days after her second HPV vaccine. Has since had 3 more seizures: 3/14/08, 5/30/08, 6/4/08. 6/12/08-ER records received for DOS 3/14/08-DX:Syncope likely secondary to dehydration related to alcohol. Presented with nonwitnessed near syncope episode. Drinking alcohol night before and might be dehydrated.
I developed red rashes on my chest and stomach and a blotchy face.  The stomach rashes we?re in some places very itchy.  I still have a itchy spot on my stomach.  On the morning of March 29, 2021 I could not get warm.  I covered myself with blankets and in the evening after not eating anything I went to bed.  The next day I was still cold.  I didn?t feel better until the next day.  I am still blotchy.