chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In March 2022, I went to get my yearly mammogram. I had developed calcifications on my right breast, so my doctor prescribed a diagnostic mammogram, which I got in April 2022. I wasn't able to get a biopsy done until mid-May 2022. At around the end of May 2022, I received a diagnosis of stage I-A breast cancer. The cancer was 7 mm, and there was a suspicious mass medial to the cancerous growth. I underwent an MRI-guided biopsy of the suspicious mass in July 2022, and it turned out to be benign. In August 2022, I underwent a lumpectomy to remove the cancer, the benign growth, and some healthy tissue surrounding them. I also had three sentinel lymph nodes removed from the right armpit. During the last week of September 2022, I began taking anastrozole daily.  I also began getting Goserelin acetate implants monthly.  I receive zoledronic acid infusions every six months; I received two in September 2022 and March 2023. In October 2022, I underwent 21 days of radiation treatment. I underwent two months of physical therapy for lymphedema of the right arm from November 2022 to January 2023. In February 2023, after I received a Goserelin acetate implant, I developed an infection in the right breast. On 2/17/2023, I saw my medical oncologist, who diagnosed me with an infection. She prescribed me tramadol for the pain and amoxicillin with clavulanic acid to treat the infection. She advised me to go to the ER if I didn't feel better and to instruct the ER personnel to give me intravenous antibiotics. The incision on my breast opened up and the infection oozed out on 2/19/2023. I ended up going to the emergency room on 2/19/2023; at the ER, I informed them of the situation and requested intravenous antibiotics. I was given intravenous antibiotics, and the ER doctor prescribed me clindamycin and instructed me to stop taking amoxicillin with clavulanic acid. I took the clindamycin for ten days; the infection cleared up, but after I finished taking the medicine, the wound was still open and draining. On around 2/21/2023 or 2/22/2023, I saw my breast surgeon. She has been monitoring my breast ever since, and the last time I saw her was 3/22/2023. At the time of this writing, there is still a small opening where the incision was, and it's still draining. My surgeon doesn't think I have an infection, anymore, but there is a reddish area above my right breast towards the sternum, and my surgeon is monitoring that closely. I have an appointment with the surgeon in the very near future, and she will let me know what she would like to do about the situation then.
pt recv vax & devel hypesthesia, lt cheek to ear, & h/a following vax w/flu;
On Jan 7, 2021 I developed a low fever (100.1), chills, scratchy throat, stuffy nose, and headache. On Jan 8, I was tested positive for Covid  with the quick result test. Fever and headache are now  gone, but I continue to have scratchy throat and nasal congestion. No medical treatment sought but I am now quarantined  for 2 weeks.
Headache - extreme pain/pressure, noon until nearly 6 pm when I took an Aleve, the pain then decreased to something like a regular migraine
Nausea Dizzy Vomiting Treatment was just to get out of heat, into air-conditioning and sleep. Outcome, after about 6 hours, no more Nausea but did not feel well for a few days.
Breaking out with traveling hives and itching like crazy  The hives began in my neck and have traveled all over  I took Benadryl
sore arm; she felt weak, she felt "off" for the entire rest of the day; she looked a "cooked lobster" (she turned red); metallic taste at the back of her tongue; Initial information was regarding an unsolicited valid non serious case was received from a consumer/non-healthcare professional (Reference number- 00807402) and transmitted to Sanofi on 11-Oct-2021.  This case involves a 69-year-old female patient who experienced she looked a cooked lobster (she turned red) (erythema), metallic taste at the back of her tongue (dysgeusia) and she felt weak, she felt off for the entire rest of the day (asthenia) and sore arm (pain in extremity), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 30-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ702AB, expiry date unknown) via an unknown route at an unknown administration site for prophylactic vaccination.  On 30-Sep-2021 the patient developed non-serious she looked a cooked lobster (she turned red) (erythema), metallic taste at the back of her tongue (dysgeusia) and she felt weak, she felt off for the entire rest of the day (asthenia) (on the same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On an unknown date, the patient developed non-serious sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  It was reported "she received the Fluzone high dose vaccine on 30sep2021.The caller reported a metallic taste at the back of her tongue, that she felt weak, and husband said she looked a cooked lobster (she turned red). The caller reported that the metallic taste lingered for a while and she felt off for the entire rest of the day. Caller states that she had a reaction after getting the flu shot and she has never had a reaction before other than getting a sore arm".  At time of reporting, the outcome was unknown for the events.
Extreme fatigue, dizziness, severe right shoulder pain, thrombosed hemorrhoids, elevated blood pressure
First complained of itching, swollen, redness, warm to touch. Took to Dr 8/17/03, was started on antibiotic. Leg looking fine as of 8/13/03.
Sensitive site, dark bruise, 2 1/2" diameter, 104 degree fever the night of shot, chills. 0129/2010 follow up- fever, vomiting, large painful bruising, cough, sniffles
Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2011 the patient was inoculated with ZOSTAVAX vaccine by a physician for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 01-JUL-2015 the patient was treated by a physician for onset of a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
vaccine stored in the refrigerator past 30 days; Vaccinated with the Moderna Vaccine after the expiration of 3/25/22; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated with the Moderna Vaccine after the expiration of 3/25/22) and PRODUCT STORAGE ERROR (vaccine stored in the refrigerator past 30 days) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient did not have any acute or chronic illness and did not test positive for COVID within last month. It was reported that patient had no known drug allergies).  Concomitant products included ORAL CONTRACEPTIVE NOS for an unknown indication.    On 01-Apr-2022 at 9:53 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022 at 9:53 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated with the Moderna Vaccine after the expiration of 3/25/22). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine stored in the refrigerator past 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccinated with the Moderna Vaccine after the expiration of 3/25/22) and PRODUCT STORAGE ERROR (vaccine stored in the refrigerator past 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that HCP confirmed that the patients were not experiencing any side effects yet.  Date the vial was initially stored in the refrigerator was 25-Feb-2022 and the vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to MOD-2022-545267 (Patient Link).
Patient got a pediatric dose for 5-11 and needed a regular dose 12 and up
Patient fainted 10 minutes post-vaccination and reportedly had shaking/seizure-like activity.  Patient felt cold and dizzy and requested transport to ER.  Transported to medical center by EMS.
On 3/26/2022, a 15-year-old received the Moderna booster instead of Pfizer. Parents made an appointment online and requested the Moderna vaccine. Contacted her parents on 3/28/2022. Parents reported she had no adverse events. Recommended parents to contact and notify PCP as soon as possible. Patient's father did not want to disclose her PCP contact information.
pain in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her left arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 006M20A) for COVID-19 vaccination.     No medical history was provided by the reporte.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in her left arm). At the time of the report, PAIN IN EXTREMITY (pain in her left arm) outcome was unknown.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Hospitalized (10.24.21);  COVID-19 positive (10.24.21);  Fully vaccinated  Discharge Provider: MD Primary Care Provider at Discharge: MD  Admission Date: 10/24/2021 Discharge Date: 10/25/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hyponatremia [E87.1] Generalized weakness [R53.1] Diarrhea, unspecified type [R19.7] COVID-19 [U07.1] Pneumonia due to COVID-19 virus [U07.1, J12.82] HOSPITAL COURSE: Patient is an 81-year-old female who presents with complaints of diarrhea and weakness.  The patient tested positive for COVID on admission which is likely the cause of her diarrhea.  Patient was also noted to be hyponatremic on presentation.  Patient's hyponatremia was likely secondary to hypovolemia.  With IV fluid administration the patient's sodium return to a normal range.  The patient was feeling significantly better and reported improvement of her diarrhea.  She was tolerating a normal diet and eager to be discharged home today.  We discussed recommendations for follow-up including a repeat BMP.  Questions have been answered to the patient's satisfaction and she is being discharged home in stable and improved condition. The patient recovered faster than anticipated leading to a faster than anticipated discharge Plus another ED visit on 10.26.21 - for COVID-19 and acute lower urinary tract infection
After injection, site bled. Cotton ball was used to apply pressure on site, then bandage was applied over site. Patient experienced injection site soreness afterwards, later on the date it developed to a bruise. 3 days post injection, soreness bothered so took a Tylenol at night to be able to sleep. Bruise has gotten darkened, purplish in color with edge yellowish, size of bruise ~1.5 inch in diameter. Full range of shoulder motion. No fever or other systemic symptoms other than the pain associated with bruise and neck sore/tightness. Suggested patient to apply cold compress, Tylenol as needed for pain and monitor symptoms and bruise. Recommended urgent care if symptoms worsen or new symptom(s) appear. Pharmacist will call patient's PCP to consult as well.
Moderna COVID- 19 Vaccine: Soon after receiving vaccination patient reported dizziness, lightheadedness, headache with radiating neck pain, nausea, flushing, and "feeling out of it". Patient was given juice and water. Vital signs obtained every fifteen minutes (total of three times) and all were stable and within normal range. Patient able to ambulate to restroom. Observed for a total of one hour and declined evaluation in the emergency department. Patient left vaccine clinic for home in stable condition.
Swelling, heat, itching started a week after the shot (Sunday 01/17/2021). On Monday there was a lump at injection site (1.5" diameter), by Tuesday morning it was hotter and doubled in size. 5 hours later it has doubled again. More heat, hardness, swelling, redness.
Naseua, chills, hot flashes, body aches, joint pain, injection site pain (HPV and Tdap). Took 2 500 mil of Advil. Still have symptoms (9:35 am).
Tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) via the Health Authority. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 22Mar2021 as a 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that, he received Pfizer COVID-19 vaccine (this past Monday) on 22Mar2021, and later tested positive for COVID-19 on (Wednesday) 24Mar21, which means he likely had COVID when he received the vaccine. On 24Mar2021, the patient underwent lab test and procedure included SARS-CoV-2 test: Covid positive. Given that you are not supposed to receive the vaccine until 90 days after being infected. He wanted to know if there was anything he should do. He appeared to be asymptomatic. He also wanted to know if he should receive the second dose of the vaccine (He scheduled to receive it on Monday, 12Apr2021). The outcome of the event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
I had a very slight very, severe headache, running nose, head congestion, fatigue, and cough. I tested positive for COVID-19 using an at home test. When I spoke to my doctor, they prescribed me Paxlovid. I tested negative and started feeling better 01/05/2023. I rebounded and tested positive for COVID-19 on 1/11/2023. I had the same symptoms with the same intensity and duration. I called y doctor again and I just ended up taking Mucinex to help with the symptoms. I didn?t test negative again until the 17th or 18th of January.
slept for 13 hours; feels he's having low sugar because he is diabetic; has not eaten anything all day; unsure if he has a fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept for 13 hours), BLOOD GLUCOSE DECREASED (feels he's having low sugar because he is diabetic), DECREASED APPETITE (has not eaten anything all day) and PYREXIA (unsure if he has a fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced SOMNOLENCE (slept for 13 hours), BLOOD GLUCOSE DECREASED (feels he's having low sugar because he is diabetic), DECREASED APPETITE (has not eaten anything all day) and PYREXIA (unsure if he has a fever). At the time of the report, SOMNOLENCE (slept for 13 hours), BLOOD GLUCOSE DECREASED (feels he's having low sugar because he is diabetic), DECREASED APPETITE (has not eaten anything all day) and PYREXIA (unsure if he has a fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication was not provided.  Treatment information was not provided.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the pt was inoculated with ZOSTAVAX injection (lot number, vaccination site, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving ZOSTAVAX, on 16-JAN-2016, the pt developed a severe case of shingles on her left ear, left eye, and left side of her face. She was treated for months, inserted eye drops every two hours around the clock. At the reporting time, the pt had multiple, debilitating recurrences of viral episodes rendering her unable to work. The outcome of the events was reported as not recovered/not resolved. As a direct and proximate result of ZOSTAVAX, the pt's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The pt experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The pt also suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Upon internal review, the events of severe case of shingles on her left ear and left eye was determined to be medically significant. The events of severe case of shingles on her left ear, left eye, and left side of her face were considered to be disabling. Additional information has been requested.
patient experienced syncope/blacking out at least 5 times in the Fall, starting in September- orthostatic hypotension, low BP , getting dizzy and blacking out hitting the floor.  Onset of daily headaches & migraines, brain fog, difficulty concentrating, general fatigue/exhaustion, cognitive impairments and lowered IQ (dropped from around 130 to 102)
began itching after shot and tingling in lips and mouth,  patient used benedryl, over period of week developed rash on both arms and back.   rash remains with redness, patient using benedryl, and topcial creams to address issue   Using Zyrtec, and Montelukast, provides relief for 12 hours or so, yet itching in groins also.  Cortaid cream, and soothing aloe gel.    Not Eczema, or psoriasis, not a food related issue either.   Seems consistent with other similar complaints online regarding booster shoot, where individuals are complaining about getting a rash, even up to two weeks after shot.
At 9:56am RN attempted to vaccinate client with 2nd dose Moderna (FOR 6 MONTHS THROUGH 5 YEARS OF AGE) Covid vaccine Lot#AR9237B into the right deltoid. The client withdrew his arm as the syringe made contact with his right deltoid and the syringe fell to the floor before the plunger of the syringe could be pushed in. RN immediately placed the wasted Moderna Covid vaccine Lot#AR9237B into the sharps container. At 9:59am Client was successfully vaccinated into the left deltoid by RN with Moderna Covid Vaccine Lot#AR9237B without incident. Client completed 15 minute observation and left site with parent.
On 10/16, 2 injections were given into the right thigh (Dtap and Flu). On 10/17, Mom called to report red hard circle approximately 3 inches in diameter around injection sites. Patient not bothered by this reaction, happy and playful. Recommended warm compresses and to call back if worsened. On 10/18/17, patient brought into office for worsening of reaction. Area of erythema was 9 x 11cm, oval that included the injection sites, slightly swollen and warm to touch, painful to palpation. The area was marked with surgical marker and started on AUGMENTIN due to concern about possible infection vs local reaction. He was also given ibuprofen and BENADRYL. Evening of 10/18/17, mom called to report the area had extended about 1/2 inch below marked area. Still no fever, child was happy, playful. On 10/19/17, child seen in office. Area of redness now extended down leg slightly and slightly posterior thigh. Initial area of injection was lighter and with patches of clear skin. At this time, it was felt by the Provider, that is was more of a local reaction. Parent was uncomfortable stopping antibiotics and it was continued. Throughout the reaction, patient had intermittent fussiness but was afebrile. Patient continued antibiotics through 10/23/17. Mom reported today 10/23 that reaction resolved.
I received the Gardasil/Gardisil vaccine 7/19.  7/20 I started experiencing itchiness in my scalp and felt the appearance of some hives on my scalp.  7/21 at night I started feeling itchiness all over my body but very few red marks appeared.  When I woke up 7/22 I had over 60 red spots (hives) all over my body, 6 on my face and neck, and the majority on my back, chest and legs.  Through out the course of that day abot 10 more appeared including a big, hard one on the back of my neck that is causing me severe headaches and back/neck pain.  7/23 I woke up with over 30 new marks (apparently the majority of the new marks come out at night).  The older marks grew in size to the approx size of a 5cent coin, and in the center small blisters have formed.  The area around the blister is very irritated (red).  A couple of them have popped, exposing a deep red dot underneath.  I went to the doctor and they have put me on benadryl for the moment, I might have to go back for a cortisone shot if the benadryl doesn't calm my symptoms.  I am experience rushes of itchiness through out, and pain in some areas (right side of my abdomen and back/neck).
Gradual loss of olfactory sense over a period of 2 to 3 months.
C/o itching and redness at site. Progressed in to generalized itching and urticaria on face. Epinephrine 0.3ml IM given R deltoid, emergency response called.
Patient returned to pharmacy 2 days after receiving PNEUMOVAX 23 in right arm complaining of redness and soreness at injection site. Symptoms improved over following 2 days according to patient.
As soon as the vaccine was given I felt dizzy and my right hand and foot got numb and tingling. This was reported to the personnel. The symptoms subsided about an hour later. Around 11pm, I started to have wheezing, chest tightness, and back pain. I have been using my inhaler and nebulizer since last night for the wheezing. I spoke to a doctor through phone who confirmed these aren't normal side effects from the vaccine.
Influenza vaccine was administered to 5 year old male in school vaccine clinic. Approximately 5 minutes later he apparently fainted as he walked back to class.  He recovered quickly and was escorted to school nurse's office, where he was monitored closely for about an hour.  His vital signs were normal (BP 82/54, T97.5. P65), with no breathing difficulty.  He was able to drink and eat, and parents took him home shortly thereafter.
pt recvd vax & exp t106.0, eyes rolled back, pt stiffened; no tonic activity; pt was screaming & holding breath just prior to event; pt alert, responsive, fussy; throat was red 2+/4; lungs clear;
Patient had a Pfizer vaccination on 2/10/21, then received a Janssen vaccination on 3/11/21.  No adverse reactions occurred with the Janssen vaccination.
Patient stated on her form that her 1st dose was Moderna. Then verbally she confirmed to the pharmacist giving the shot that she was getting 2nd dose Monderna.  She was given the shot and then became aware that she is only 16 and her 1st dose was Pfizer. As far as pharmacist is aware no true adverse effect happened from getting the Moderna shot.