chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnancy History: due date 11/23/21, gave birth to healthy baby girl 5lb 12oz. Was induced early due to hypertension leading in to preeclampsia starting at 35 weeks Symptom History: Paresthesia in limbs, noticed weakness and numbness starting in left leg in 8/2021 and assumed it was related to the pregnancy. It spread to left arm around 05/2022. The weakness, numbness, and loss of dexterity was bothersome enough that I started seeing doctors in July 2022. Had MRIs and bloodwork in July with no diagnosis. I saw an ophthalmologist and was checked for neurological eye issues and was cleared. By August it was spread to right side and by October I was experiencing numbness in my lips, tongue, scalp and neck as well as the limbs. I had neuro exams with no diagnosis. By December, on my vsafe checkin (I signed up as a pregnant recipient of the covid vaccine and had been doing regular checkups) I was recommended to file an adverse event to investigate whether the vaccines were related - by that point I had both primary Moderna shots as well as a bivalent booster. I saw a cardiologist in January 2023  and had an echo and a stress test with no diagnosis. I saw an allergist in March 2023 with no diagnosis. As of this submission in June 2023, my symptoms persist without diagnosis. I also noted over that time frame ~8/2021-present I have had small bouts of vertigo on the rough magnitude of a couple times a month.
Rash on forearm of right arm; Extremely itchy; very sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 34-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date; not reported), via an unspecified route of administration, administered in Arm Right on 26Feb2021 15:00, as a SINGLE DOSE for covid-19 immunization. The patient medical history included long term gird after having h. Pylori (gastrooesophageal reflux disease) and allergies to penicillin. The patient concomitant medications included pantoprazole and loratadine. No other vaccine in past four weeks. On 02mr2021 at 09:00 pm, the patient experienced rash on forearm of right arm, extremely itchy and very sore. Rash on forearm of right arm. It showed up four days after vaccine dose. Extremely itchy and now very sore. Area of about 8 10 inches by 5 inches at widest points. Patient did not receive any treatment as adverse event. No covid prior vaccination. No covid tested post vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
flu like symptoms; Upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and ABDOMINAL DISCOMFORT (Upset stomach) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and ABDOMINAL DISCOMFORT (Upset stomach). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and ABDOMINAL DISCOMFORT (Upset stomach) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Systemic joint inflammation and pain; unable to sleep for three weeks until prednisone  Nine weeks to return to normal function and mobility
Prevnar 13 was administered on 09/18/15, and then a second dose on 09/02/16. No adverse effects reported as of the filing of this report.
The pt experienced a fever about 1 hour post vax. Temp was 102 with complaints that he left arm hurt. The fever responded to Tylenol. Temp this morning was 101. Advised to continue with Tylenol and apply cold compresses to left arm.
I was having a lot a breathing difficulty. I had headache and was congestive. I went to a clinic and then to the ER. They did not run any test or diagnosis me with anything.
COVID positive; COVID positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), 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: "Reactive depression" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Feb2023, outcome "unknown" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Feb2023) Positive; (10Feb2023) Negative; (12Feb2023) Negative; (17Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 06Feb2023 to 11Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rising fever, starting at 100.4 degrees F on the morning after. In the afternoon the fever continued to rise to 100.8 F despite taking acetaminophen.
No adverse etfects were reported.; the patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. 01-OCT-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S003868, expiration date 08-AUG-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 6 to 14 (7.2) degrees Fahrenheit for 2 hours. Data logger was involved. There were no previous excursions reported.
muscles throughout body still ache; very disoriented; did not feel safe to drive.; bad headache; all over body aches,; nausea; good deal of pain in left arm; hand was cramping up (arm of injection).; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Mar2021 at 17:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included moderate to severe asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included SYMBICORT taken for an unknown indication from an unknown date and unknown if ongoing. On 04Mar2021 at 23:00, the patient experienced a good deal of pain in her left arm and hand was cramping up (arm of injection). On 05Mar2021, in the next day, the patient felt very disoriented and did not feel safe to drive, bad headache, all over body aches, and nausea. She had to leave work after a couple hours in the second day and rested for the next two days bit still she had noticeable bad symptoms. After three days she was mostly felt okay. On 11Mar2021, a week later, her muscles throughout the body still ache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events good deal of pain in left arm, hand was cramping up (arm of injection), felt very disoriented, did not feel safe to drive, bad headache, all over body aches, nausea, and muscles throughout the body ache was resolving at the time of this report.   No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Insomnia, irritability, nausea, headache 24 hours after shot : mild food allergy symptoms (nausea, vomiting, diarrhea)
Diarrhea, h/a, aches in kidney area duration 1 1/2 days;
11JUN91 pt recvd TD; 12JUN91 fever upon awakening;
Started to feel tired around 7:00 Pm the night after getting the vaccine. Went to bed thinking I could sleep through any discomfort.  Woke up at 8 pm with shooting pains in my head and sever joint pain. Temp was 101.5.   Took a motrin PM. could not sleep for more than 10 min at a time. At 10pm took 2 reg motrin. tepm each hour after reduced by0.5. Still with server headache and body aches until 4AM. I have never felt as bad as I did for those 8 hours, even with the flu
This spontaneous report was received from a 61 year old female patient regarding herself. Pertinent medical history was reported as none. Drug reactions/allergies to sulfa drugs. Patient had a dose of PREVNAR 13 in 2016 but had not had any reaction. Concomitant medication included a dose of tetanus vaccine in the other arm on 16-JAN-2018. On 16-JAN-2018, the patient received PNEUMOVAX 23 intramuscularly for prevention of pneumococcal disease (dose, lot# and expiry date were not reported). The patient experienced itching at the site of injection within a couple of hours after receiving the vaccine (Vaccination site pruritus). Patient stated that it started with itching at the area of the injection then progressed. Patient had a welt the size of a dollar which tripled in size (Urticaria) and was extremely painful. It then spread to the upper quadrant of my back and was so painful that she couldn't move her arm (Injected limb mobility decreased) or touch it (Administration site hypersensitivity) on unspecified dates. Laboratory tests were reported as none. The patient had reported the event to her provider who directed her to apply ice pack and take ibuprofen (ADVIL). Outcome and causality of the events were not reported.
Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received Hib (Hiberix) (batch number 25Z52) for prophylaxis.   On 04-JAN-2023, the patient received Hiberix. On 04-JAN-2023, an unknown time after receiving Hiberix, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter US-GSK-US2023AMR060527:same reporter US-GSK-US2023AMR060523:same reporter US-GSK-US2023AMR060577:same reporter US-GSK-US2023AMR060588:same reporter US-GSK-US2023AMR060624:same reporter US-GSK-US2023AMR060616:same reporter
She was admitted to the hospital on 1/24/21 with acute symptoms of fatigue, malaise and some increased confusion.  Patient also developed a junctional heart rhythm on night of admission.
I got up and saw a bruise on my arm, I had not hit myself to get a bruise. It began spreading to other parts of the body, on foot, stomach, back of my hand, etc. I started to develop weakness in the muscles, especially in the legs, and pain also followed. I went to see my doctor, who pulled some blood for labwork. She referred me to a hematologist and a neurologist to see what was going on, but I never got to the appointments because I had a heart attack due to clotting. They had to put in 3 stets in because it was so bad.
1408 Vaccination nurse punctured patient with Moderna Bivalent vaccine syringe, after administering vaccine nurse had notcied leakage out of syringe.
This spontaneous report as received from a nurse practitioner refers to a 53 year old female patient with no medical history and with no drug reactions/allergies. On 08-APR-2013 the patient was vaccinated with ZOSTAVAX (lot # J000435, exp date as 10-APR-2014, subcutaneously in the right upper arm, dose unspecified). Other suspect therapies included ENGERIX-B (manufacturer unknown) (in the right upper arm, Lot#, dose/frequency, route and duration were unspecified) on the same day. There was no concomitant medications taken. On 09-APR-2013, patient developed "a red, itchy indurated area around the injection site where ZOSTAVAX was administered in the patient's right upper arm". Patient had sought medical attention via office visit, no lab diagnostics studies were performed. Treatment of CLARITIN was given for the event. The outcome was reported as recovering. Drug relationship was not provided. Additional information is not expected.
lt arm deltoid red; edema, warm to touch; 30mm tx-75mm tender; Td immu 18MAR93 referred to pvt MD;
4/2/2021 - pain in right arm starting at injection site.  Over next 18 hours pain ran along arm to shoulder to upper back.  Pain starts as sharp, then burning.  Patient had difficulty sleeping.  Started on ibuprofen (1000mg) at 8am on 4/3/2021 and heating pad.  Pain dulled a bit.  Additional info: on 3/27/2021 Patient woke up with a droopy eyelid that was diagnosed as Horner?s Syndrome on 3/31/2021 .  Sent to ER at  Hospital  for MRI/MRA/CT, scans showed nothing conclusive - no evidence of stroke, aneurysm, clot,  cancer, or anything pressing on optical nerve.  Have followup with Dr at Hospital Neurology.  Blood work ordered to check for evidence of other conditions that could deteriorate the myelin sheath.
Pt recv vax on 12/6/97; on 12/16/97 pt exp brachial neuritis, pain at vax site-LA
Nausea, vomiting, fever, swollen injection site for at least 48 hours. Weakness that continues 6 days after the event.
This spontaneous report was received from a pharmacist and refers to a 71 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-AUG-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L035686 with an expiration date: 16-FEB-2017), intramuscularly (dose and anatomical location were not reported). On approximately 31-AUG-2016, reported as later that night, the patient started experiencing swelling at the injection site that was tender and warm to the touch. The following morning the patient came to the pharmacist and was told to use BENADRYL as treatment and contact to her doctor. None lab diagnostic studies were performed. The outcome of the events was reported as not recovered. The relatedness between swelling at the injection site that was tender and warm and PNEUMOVAX 23 was not reported. Additional information has been requested.
Intense, severe pain in my upper arm, radiating out from the site of the shot. The pain was so intense that I could not use my arm. This pain stayed at the same intensity for about 3 hours, even though I took ibuprofen and Tylenol about an hour after I received the vaccine. The pain started to subside VERY slightly after about 4 hours, and was much better the next day.  I have never experienced such an adverse reaction to the flu shot.
Itchy red rash around neck and sides of face.; Red rash; This is a spontaneous report received from a contactable consumer. A 78-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EP 7534), via an unspecified route of administration on the arm left on 17Mar2021 at 11:30, as single dose for COVID-19 immunisation. Medical history was reported as heart disorder, diabetes, high blood pressure and allergy to bee sting and venom. Concomitant medication was reported as atorvastatin (MANUFACTURER UNKNOWN) at a dose of 80 milligram, glimepiride (UNKNOWN MANUFACTURER) at a dose of 02 milligram and atenolol (UNKNOWN MANUFACTURER) at a dose of 25 milligram for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 2 weeks prior to the COVID-19 vaccine. On 19Mar2021 7:30, the patient experienced itchy red rash around neck and sides of face and red rash. The patient did not received treatment for the reported events. Patient did not visit to the doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care for adverse event. The clinical outcome of events itchy rash was not recovered. The clinical outcome of red rash was unknown.   No follow-up attempts are possible. No further information is expected.
devel reddened area 1 1/2cm in diameter @ the inj site following flu vax;also devel generalized itching approx 18hrs p/vax
He started becoming sick on Saturday, and I was at the hospital having a baby at the time, so he was at my sister's house. He wouldn't eat and he would also have tantrums and he was acting like something was wrong. He didn't sleep that night or the next night. He would not sleep and he was acting sick. He would not sleep or eat and was uncomfortable. When he came home on Monday on July 4, he came down with a fever. I gave him some of the infant TYLENOL and made sure he wasn't too hot. I monitored him throughout the night. He had a runny nose and he was crying a lot. He also had the fever. I asked my sister if her daughter was sick as well, and she said no. The next day my sister had a fever and her COVID-19 test was positive. So on July 5, we all took at-home COVID-19 tests and we were all positive except my new baby. He was screaming and crying, fevers on and off for the next few days. He was really irritable, and it was really sad to see. I'm hoping that the vaccine gave him some protection. We also had to constantly suck the mucus out of his nose and almost had to take him to the hospital because he couldn't breathe very well. We also used one of those pots to flush his nose and that helped so he could breathe again. He was mad and hitting his head on stuff. He was upset and was taking it out on me. It was horrible with him. He is getting better. We did test again on Sunday, July 10, he tested negative but he was still having symptoms. He was still having symptoms although he tested negative, so we continued to quarantine. Today, he's still sick but he's a lot better than he was. He's been eating most of his meals and sleeping through the night now. He pretty much didn't sleep through the night for maybe a week. The fevers have been gone for a while now. He also did lose his voice from crying, but he was hoarse and had no voice. He's still sick but better than he was. And I still need to help with the runny nose and congestion. He did also cough during his infection. Basically his symptoms during the infection included coughing, congestion, runny nose, fever, tantrums, disinterest in eating and not being able to sleep.
On 02/17 evening a mild fever of 100 began and on 2/18/20108 the rash began and was all over body looking like measles by that night. 2/20 daycare provider noticed a small 1cmX1cm lump on the left side of her neck.
serious allergic reaction; Initial information was received on 06-Dec-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (patient) via social media.  This case involves a patient (demographics unknown) who had a serious allergic reaction (hypersensitivity), when received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in 1992, the patient developed a serious allergic reaction (hypersensitivity) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. The patient could not get one anymore. The allergy specialist said the next one could actually kill the patient.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  Information on batch number was requested for this case.; Sender's Comments: This poorly documented case from social media concerns a patient who had hypersensitivity after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Breakthrough case admission after 2 vaccines Moderna 5/8/21 Lot# 005C21A;  Moderna 6/12/21 Lot# 041C21A
ACUTE ST ELEVATION MI, ANTERIOR WALL ACUTE NON ST ELEVATION MI ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Child slept for 7-8 hrs after shots, not responsive to stimulation. Was seen at medical center. Was told heart rate was slow.
18 to 24hr p/vax pt devel fever of 104.5 & exp febrile sz;pt recovered;
Child was administered an adult dose (30mcg) of the Pfizer COVID-19 vaccine instead of the child dose (10mcg).
Tested positive for Covid on 6/26/22 after exposure. I had two negative results prior to the positive result.