chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Nurse practitioner refers to a female patient of 74 years of age. The patient's concurrent condition included asthma and hypertension. The patient's drug reactions/allergies were reported for penicillin, prednisone, ZANTAC, TAGAMET, PEPCID, PREVACID, DILAUDID. On an unknown date, the patient was vaccinated with hepatitis b vaccine (manufacturer unknown) (dose, route and lot number not reported). Concomitant therapies included TOPROL, CLARITIN, FLOVENT and hydrocodone. On an unknown date, the patient experienced respiratory arrest after receiving hepatitis b vaccine (manufacturer unknown). The patients present status was reported as recovered (date unspecified). The patient sought of medical attention. No product quality complaint (PQC) was reported. Upon internal review, the event respiratory arrest was determined to be medically significant. On an unspecified date, patient experienced local reaction after receiving pneumococcal vaccine (manufacturer unknown) (reported in MARRS # 1409USA004713/same patient link). Additional information has been requested.
received either two or three doses of GARDASIL 9 "approximately 5 years ago," with the "second dose in 2015/in April 2021 administered another dose of GARDASIL 9; No additional adverse events or product quality complaints were reported.; and in April 2021 administered another dose of GARDASIL 9; This spontaneous report was received from a consumer regarding to her sister, a female patient of unknown age. The patient's medical history, drug reactions or allergies and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route, anatomical location , lot # and expiration date were not provided).   On an unspecified date in 2015 (conflicting information also reported as approximately 5 years ago), the patient received the second dose according to the sister's medical record, receiving "either two or three doses" of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route, anatomical location , lot # and expiration date were not provided).    On an unspecified date in April 2021, the patient received another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis. No additional adverse events or product quality complaints were reported.
Order for Hep A pediatric adolescent. Given as ordered. Per vaccine recommendation should have received the adult formulary.
It was pretty subtle at first and then it became more noticeable. On Saturday, it was unbelievably painful. My heart rate was in the 140s or 150s. I thought maybe I was dehydrated. It just became more and more persistent. Even at rest, it was hanging out between 90-110. If I just got up and did anything minimal it would shoot to the 120s-130s. I almost went to the ER Sunday night. I went to see my doctor on Monday afternoon. By Tuesday, it was very minimal. Sometimes when I get a pericarditis flare up, I get an exacerbated heart rate. She did an echo. She did an EKG. Everything looked fine. We don't know what triggered my pericarditis. I have not experienced anything like this again since about 3 days after my 2nd dose.
Started breaking out in hives all over my body a week after 2nd dose. Has continued through today. Dermatologist has me taking 2 Zyrtec every morning to manage symptoms
I got a Mighty sore arm about 4 hours after injection. 30 hours later I began to feel agitated and grouchy. I woke up about 44 hours after vaccine with a painful and swollen left thumb joint.  I felt strangely tired.  While walking a couple of hours later I felt drunk and dislocated from my body.  48 hours after receiving the vaccine, I felt a shocking jolt to my entire body.  Immediately my left arm began a deep painful tingling from my shoulder to my fingertips, then began to feel numb and tingling and as if it were swelling. I lost my vision, felt like I was going to pass out, turned extremely pale, broke out in a cold sweat, then my shins and feet began to tingle. I felt as though I couldn?t breathe.  My vision came back but my body felt dislocated and my head a cinder block. It took great concentration to move my limbs and speak.  I couldn?t find the words I wanted.  This lasted for about 15 minutes just like a complete shock to my nervous system.  I was very irritable and exhausted for 4 days following.
On 4/23/00 pt experienced papules with erythematous macules, plus vesicles and oral lesions. Pt is afebrile.
Redness and warmth several inches below the injection site. There is a small bruise at the injection site, but no erythema, fluctuance or discharge. She has had no systemic fever and no other symptoms.
Dose 1 given 2/19/2021 Moderna Lot # 024M20A Pt was boarded in the ED for psychiatric needs 8/2/2022-8/5/2022 at a local hospital
Beginning in August of 2021, I began experiencing heavier periods, spotting and breakthrough bleeding in the week leading up to my period. I have been having awful cramping, bloating, 2 week long periods, and this is all while on being on birth control. It has been confirmed by my physician that I am not in menopause, and suspected I am also anemic.
This spontaneous report as received from a pharmacist refers to an 18 year old female patient. In 2008 the patient was vaccinated with her first dose of GARDASIL (lot#, dose, route not reported). In November 2013 the patient was vaccinated with her second dose of GARDASIL (lot#, dose, route not reported). In February 2014 the patient was vaccinated with her third dose of GARDASIL (lot#, dose, route not reported). Concomitant medications were not provided. No adverse effects were reported. Additional information is not expected because the reporter did not want to be contacted.
Low grade (100) fever in early evening of the following day. Was 105F by 6:00 PM intermittently throughout the weekend, was able to bring down with cool bath and compresses and kids Motrin then would drop to below 96, then spike back up to 105.  This happened throughout the weekend. He was lethargic as well, no other symptoms.  Not flu like. No N/V/D or cough during the weekend or in the week following. Monday morning I took him to the DR.
Vaccine adulterated due to temperate excursion.  No adverse events experienced/reported by patient.
Pt complaining of pain level of 2 (1-10 pain scale) said it hurts when she sleeps on it or touch it. Pain occurs infrequently, but noticeable since administration on 10/9/15.
DOB ON CONSENT LISTED INCORRECTLY. OTHER RECORDS INDICATE DOB A YEAR YOUNGER. POSSIBLE UNDERAGE AT TIME OF VACCINE ON 6/9/2021.
Patient with 3 COVID vaccinations who admitted with complications from COVID.  Provider d/c note:  "89 YO female with a PMHx of ITP, HLD, ILD, essential tremor, CAD, osteopenia, colon cancer s/p colectomy who presented with dry cough, SOB, and generalized weakness. Pt was suspected to have acute hypoxic respiratory failure 2/2 ILD and was started on prednisone 40 mg daily. Pt's oxygenation and dyspnea improved with prednisone and we were able to get her off of oxygen briefly on 8/2. However, she started requiring it again on 8/3 up to 5L NC, which we were able to wean to 2L NC before discharge. Plan to taper her off of prednisone after discharge. Of note, Pt tested positive for COVID-19 in June 2022. She was treated with steroid and paxlovid at that time. Pt given COVID-19 2nd booster on the day of discharge. Pt discharged in stable condition. Recommend weaning off oxygen as tolerated. "
Symptoms started 2 days after I got my injection. I had a massive migraine, body aches, chills, fever with temperature reaching 102. Symptoms lasted 24 hours. The following day I felt fine again.
severe herpes zoster or shingles; did not prevent shingles as intended; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of an unknown age.  There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On or about 04-NOV-2014,  the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles at a pharmacy. On an unknown date, the vaccine did not prevent shingles as intended and the pt subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date, the pt was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of  zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving  zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles, the pt suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions the pt suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the pt had suffered and would continue to suffer significant medical expenses, and pain and suffering and other damages. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
developed hives continuing to this day, chronic urticaria, all over the body, legs, body, arms, lips, mouth, head, mostly in the back, chest and legs; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (developed hives continuing to this day, chronic urticaria, all over the body, legs, body, arms, lips, mouth, head, mostly in the back, chest and legs) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 044A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Thyroid cancer and Blood pressure abnormal.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jul-2021, the patient experienced URTICARIA (developed hives continuing to this day, chronic urticaria, all over the body, legs, body, arms, lips, mouth, head, mostly in the back, chest and legs). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at a dose of UNK, prn; ALBUTEROL [SALBUTAMOL] for Adverse event, at an unspecified dose and frequency and OMALIZUMAB (XOLAIR) for Adverse event, at a dose of UNK, qmo. At the time of the report, URTICARIA (developed hives continuing to this day, chronic urticaria, all over the body, legs, body, arms, lips, mouth, head, mostly in the back, chest and legs) had not resolved.            He had thyroid cancer years ago, he changed thyroid medication from one brand to synthroid in the event that would be the cause of his reaction and also was taking blood pressure medicine but quitted it because of this too.
Patient provided second vaccine prior to 21 days. Patient received 13 days after first dose.
Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion); Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The reporter was an internal medicine manager. It was reported that, there had been no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that, no adverse reactions were reported by the patient. The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient. No treatment medication was reported.
Pt. received Dose of Varicella and dose of Proquad on the same date and time. Family has been informed and no report at this of any side effect.
17Apr89 pt vax w/ 3rd hepta B; devel large wheal at inject site, axillary + trunk hives accom. by urticaria that lasted 1 week. Tx w/ Topicort + Chlor-trimeton.
Administered (L) arm IM deltoid - injection site swelled up within 5 second to size of 1 inch x 3 inch raised by 1/2 inch monitored for 15 minutes with no worsening symptoms. MD notified - ok with pt self monitoring; call if worse.
Within 1-2 hrs after injection, Pt C/O joint pain, muscle pain, injection site, red, swollen, painful down to above elbow. Felt weak, lethargic, temp was 101.4 and went up and down for 3 days following injection. No appetite, both feet felt numb between toes and on top/bottom of feet. Had HA and pain in throat on one side only when swallowing. Symptoms slowly resolving. Still not 100% as of 7/24.
Profuse watery vaginal bleeding 12 hrs after injection. Bleeding lasted approximately six hours. After first injection and vaginal bleeding, gynecology exam completed for abnormalities; This is a spontaneous report from a contactable physician (patient). A 55-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), intramuscular in the left arm on 22Dec2020 at 16:00 at a single dose; and the second dose via intramuscular in the left arm on 08Jan2021 at 08:00 at a single dose as COVID-19 vaccine. Medical history included a known latex allergy and previous spontaneous cerebral artery dissection x 3 ( nonspecific connective tissue disease). The patient was not pregnant at the time of vaccination and did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. Concomitant medications (reported as other medications within two weeks of vaccination) included estrogens conjugated (PREMARIN), micronized progesterone, colecalciferol (Vitamin D), folic acid (FOLATE), and diphenhydramine hydrochloride (BENADRYL). On 23Dec2020, the patient experienced profuse watery vaginal bleeding 12 hours after the injection. The bleeding lasted approximately six hours. After the first injection and vaginal bleeding, a gynecology exam was completed for abnormalities. Previously diagnosed uterine fibroids present and some free fluid in the pelvis by ultrasound. Bleeding resolved by the end of post-vaccine day 1. After the second vaccine, heavy vaginal bleeding started 10 hours after a injection. It was reported that the adverse event result in a doctor or other healthcare professional office/clinic visit. Treatment for the event involved removal of the IUD. Outcome of the event was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).  Information about the lot/batch number has been requested.; Sender's Comments: There is reasonable possibility that the event vaginal hemorrhage is related to suspect drug BNT162B2 based on a compatible temporal relation between vaccination and the onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
This spontaneous report as received from a physician refers to a currently 22 year old non-pregnant female patient. On 14-NOV-1997 the patient was vaccinated with the first dose of RECOMBIVAX HB injection, 0.5 ml, intramuscularly (lot number and expiration date not provided). The second dose was administered on 18-DEC-1997 and the third dose was administered on 22-MAY-1998 (also reported as 22-MAY-1997). The reporter stated that on an unknown date a titer for hepatitis B were drawn and the titer resulted negative. No treatment was given for adverse event. The outcome of hepatitis B titer negative was unknown. This is one of 10 reports from the same source. (1309USA005675, 1309USA007825, 1309USA007826, 1309USA007827, 1309USA007828, 1309USA007829, 1309USA007830, 1309USA007831, 1309USA007831, 1309USA007833). Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of autoimmune disorder in a 18-year-old male patient who received FLUARIX TETRA (batch number 2J2EC, expiry date May 2018). Concurrent medical conditions included Crohn's disease. Concomitant products included Mesalamine. On 9th August 2017, the patient received FLUARIX TETRA (intramuscular) .5 ml. On 11th August 2017, 2 days after receiving FLUARIX TETRA, the patient experienced autoimmune disorder (serious criteria GSK medically significant). On an unknown date, the outcome of the autoimmune disorder was unknown. It was unknown if the reporter considered the autoimmune disorder to be related to FLUARIX TETRA. Additional details were reported as follows: On 9th August 2017 at 12:00, the patient received FLUARIX QIV vaccine on left deltoid. It was reported to pharmacist that a patient experienced an auto-immune reaction that was not related to Crohn's disease.
This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 9-OCT-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J006156 and expiry date 30-AUG-2014. Dose and route were unspecified. The reporter informed that a shipment (referred as second) of improperly stored ZOSTAVAX vials (lot number J006156 and expiry date 30-AUG-2014) received on 11-OCT-2013 were exposed to 5 degrees centigrade for approximately 41 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 9 of several reports from same reporter. Additional information has been requested.
Swell ( 3 inches in diameter) and redness at injection site which feels hot and hard to touch.   Narrative:
Within a few hours of 2nd dose, I was running fever of 102.5, very sweaty, severe muscular pain all over, very sleepy and foggy headed
Patient became light headed and passed out.  Lost consciousness for less than 5 seconds and then sat up.  Was sweaty but quickly felt better.  Gave patient orange juice as he had had nothing to eat or drink since last night.  He would not allow us to call the ambulance for him.  told him to wait around for 30 minutes after he stated he as feeling normal allowed him to leave.  Spoke with patient today and said he was feeling fine.
Received a Positive covid-19 diagnosis after first shot and before the second shot.; Received a Positive covid-19 diagnosis after first shot and before the second shot.; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient received a positive COVID-19 diagnosis after first shot and before the second shot. Event took place after use of product. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Supra ventricular tachycardia occurring during intense exercise like hiking and shoveling snow
Full dose wasn't given. The needle separated from the syringe (while in the child's thigh) and the immunization spilled out .
This spontaneous report was received from a 55 year old female nurse, who is the patient, via a company representative. On approximately 03-JUL-2014 the patient was vaccinated with PNEUMOVAX23 (does, route and lot # were not reported). Concomitant medications were not reported. In JUL-2014 the patient experienced all of the lymph nodes in her body swelled up after administration of PNEUMOVAX23. The patient stated she could not put her arms down and could not lie on her side due to the pain. It was also reported that the patient ached all over and had pain while walking. The patient took aspirin due to the adverse events. The patient sought medical attention. The outcome of the events was reported as recovering/resolving. Additional information has been requested.