chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 3:15 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Oct-2021 at 3:15 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The patient was given dose from vial that were stored in an ultracold freezer which was colder than they should have been. The facility had a temperature excursion for the Moderna COVID-19 vaccine and the patient was administered the vaccine underwent temperature excursion.  Excursion duration was 1 month; on 19-Nov-2021, the vial moved from super cold freezer to the refrigerator; 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator; no vaccine state changes were noticed; none of the vials were punctured and no previous temperature excursions.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-402935 (Patient Link).
Painful lump in the sternal area of the (R) clavicle which started right after receiving her covid vaccine
Right leg tight; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Right leg tight) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced LIMB DISCOMFORT (Right leg tight). At the time of the report, LIMB DISCOMFORT (Right leg tight) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided. Patient received 2nd dose 16thMarch2021 in her right arm. After the 2nd dose she noticed her right leg tight. She´s still feel´s it that way on 24thMarch2021
GI bleed K92.2 - Gastrointestinal hemorrhage, unspecified
I think the neurologist described it well as syncopy. I was perfectly fine until around 11pm when the adverse effects happened. First, I went unconscious for around a minute while seizing, vomiting, and evacuating my bowels. I was watching TV with my dad at the time and we felt better when I regained consciousness. Then about half-an-hour later, it happened again and then my brother, convinced my dad, to take me to the nearest hospital.  They took good care of me and the worst was already behind me. The staff will likely elaborate better,  but basically they gave me fluids and diagnosed me well given the circumstances. Obviously, 05/20/2021 sucked...  I felt completely drained in the waiting room. It took thirty or so minutes before entering the ER, but that's fair because there were a few people before me. I entered and it was fluids, questions, and rest. 05/21/2021 wasn't as bad. I felt achy, but otherwise normal. 05/22/2021 I felt okay, but the hospital wanted me to stay another night under observation. Then, I believe the hospital released me the afternoon of 05/23/2021. I felt completely normal and fine since.
First got a headache at 9:00 pm. Then a few hours later had diarrhea, body aches, fatigue. These symptoms lasted around 3 days. Right arm was really sore, almost to a point that I didn't want to use it. This lasted around 5 days. Also had a bruise at injection site.
Friday PM patient felt run down and tired body aches and pain lasting till Saturday. Sunday AM migraine with aura.
I noticed my low-grade, chronic arthritis pain had started to fade last week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing), notes: Verbatim: Arthritis. The patient's concomitant medications were not reported. Past drug history included: Tylenol for acute arthritis pain. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Mar2021, outcome "unknown", described as "I noticed my low-grade, chronic arthritis pain had started to fade last week".  Additional information: It was reported that Pfizer covid vaccine seems to have made patient's year-long arthritis symptoms finally disappear. Since last winter, when she believed she got covid (unable to be tested), she had suffered episodes of acute arthritis pain necessitating arthritis Tylenol (she did minimal medicine). She got her first Pfizer covid vaccine on 02Mar2021 and she was due for the second shot on 22Mar2021. But she noticed her low-grade, chronic arthritis pain had started to fade last week.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
headache 3 d. after vaccine fever, chills same d. as vaccine numbness L arm, perinasal Now resolved headache, numbness
4/11 around 8am my nose just out of the blue started bleeding profusely.  I tried about 40 minutes to stop it but wasnt successful so I was transported to hospital ER  where they had to cauterize it just to get it to stop.   I was advised I could not take anything but Tylenol to try to ensure the bleeding did not start again.   It never really got any better and I began developing a weird head pain in my head,  which caused severe headaches which the pain  being felt in my face and behind my eye area.  After the pain continued to get worse on 4/22 I had a virtual visit with Dr. who prescribed a steroid and antibiotic and advised I see an ENT.  I havent had any more nose bleeds but I do still get intermitten headaches from time to time
19MAR AM mom noted approx 10 macular spots on child, one pimple like spot on neck;5PM 19MAR pt devel T103-given APAP;started sz temp inc 104 in 20min;tx in ER intubated taken to larger hosp;T101-104.5 x 9d;WBC dec;laryngeal stridor/croup x9
Extreme redness and swelling at injection site. Patient was fatigued and had diarrhea and vomiting x 3 days.
Fever starting 12 hours after the dose. Night sweats starting 3 days post-vaccine and continuing nightly since. Day 7 post vaccine was worst case of night sweats.
Pfizer Dose 1 8/19/21 (FC3182) Pfizer Dose 2 9/9/21 (FF2588) Pfizer Dose 3 2/15/22 (FJ8757) COVID Positive 2/18/22  2/17/22: Patient is 69-year-old male with past medical history of CAD Sp PCI with deployment of DES on 12/27/2021, hypertension, dyslipidemia, type 2 diabetes mellitus, GI bleed with no clear etiology and gastritis/duodenitis with esophagitis with esophageal ulcer.  He presented to the emergency room with a complaint of shortness of breath and dizziness x 4 days.  Patient was in relatively good state of health until 4 days ago when he started to have exertional dyspnea.  Since 2 days ago, he has been having associated dizziness and lightheadedness.  He denied chest pain or palpitations.  Patient reported that he was started with iron pills 5 days ago by his PMD.  Since then, he has been having dark stool.  No bright red rectal bleeding.  No nausea vomiting or abdominal pain.  No hematuria or epistaxis.  Patient reported taking his dual anti-platelet therapy aspirin and Plavix regularly.  Patient drinks alcohol only occasionally.  He denied use of tobacco products.  Patient was recently admitted to Genesis from 1/31/2022 through 2/5/2022 for GI bleed with acute blood loss anemia requiring transfusion.  Patient underwent EGD and colonoscopy.  Colonoscopy was unremarkable.  EGD revealed gastritis and esophagitis with esophageal ulcer but no active bleeding.  Patient was scheduled to undergo capsule endoscopy as an outpatient.  Patient called gastroenterologist office but he was told that he is not scheduled for the test.   Upon evaluation at the emergency room, he was hemodynamically stable, afebrile and maintaining saturation on room air.  Labs were significant for normocytic anemia with hemoglobin of 6.1 gram/deciliter compared to 8.1 on discharge weeks ago.  Patient had mild leukocytosis at 11,000. At the ED, he was started with IV Protonix drip and IV fluid is normal saline 1 L. patient also received transfusion with 2 units of PRBC.  2/20/22: The patient was admitted underwent treatment for acute blood loss anemia with PRBC transfusions and stabilization of hemoglobin hematocrit.  He underwent repeat endoscopy by GI.  He was advised to follow up with outpatient GI to complete the workup including capsule endoscopy and colonoscopy.  On the day of discharge the patient was seen and examined bedside, states he is feeling well, no bleeding reported.  Hemoglobin hematocrit stabilized upon the day of discharge. He was discharged in stable conditions. Total time spent on d/c process 40 minutes
My appointment was at 3:40pm on 12/17/21. They people at the pharmacy were flustered. It was evident they were rushing and disorganized. It was also very busy at the time. After receiving the shot at pharmacy, the nurse did NOT instruct me to wait and said, "I was free to go." At 4:14pm I proceeded to my vehicle to drive home. Within 5 minutes of driving home I felt faint, my vision blurred out and seconds later fainted and crashed into a fence atop of bushes and cement. My guess is I was unconscious for less than a minute before i realized I had indeed fainted and crashed my car. $3000-4000 worth of damage to my car minimum!
Uaricella - Information has been received from a registered nurse concerning a 40 month old male who on 09 Jan 1998 was vaccinated with one dose of varicella virus vaccine live sc in the left arm.  there was no concomitant medication.  On 04 apr 2000 the patient experienced chickenpox with 25-30 lesions on the chest, back, and face.  he was seen by a physician.  he was given diphenhydramine HCL (benadryl as needed
Small red rashes on all parts of the body; small allergic reaction; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0175), via an unspecified route of administration on 01May2021 at 03:00 (at the age of 35-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03May2021, the patient experienced small red rashes on all parts of the body included legs, arms and head. Felt like a small allergic reaction. Gone after taking antihistaminic. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events included antihistamines. The clinical outcome of the events was recovered in May2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: event Rash all over was removed, it subsumed with Red rash as Erythematous rash.
Periodic chest pain/heaviness as well as occasional shortness of breathe; Periodic chest pain/heaviness as well as occasional shortness of breathe; periodic chest pain/heaviness as well as occasional shortness of breathe; Tingly sensations in my left arm; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Mar2021 09:00 at the age of 39-years-old (Batch/Lot Number: EP7533) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation.  Medical history was None.  There were no concomitant medications.  The patient previously took cefalexin monohydrate (KEFLEXIN) and experienced allergies. There was no other vaccine in four weeks. There were no other medications in two weeks. The patient did not get covid prior vaccination. covid was not tested post vaccination. The patient stated she began to have tingly sensations in her left arm like it was 'asleep' from 02Apr2021. The tingly sensations started to move to her other limbs, and she went to see her neurologist (Name). He ran some test, blood work and an MRI of the Brain and no issues were found. In the last two to three weeks, she had been having periodic chest pain/heaviness as well as occasional shortness of breath from 02Apr2021. She went to the local urgent care; they did some blood test and again no issues found.Today she went to her neurologist to report her symptoms and he had made her an urgent cardiologist appointment for 3Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood test: no issues were found, MRI Brain WO: no issues were found, nerve tests: unknown results, all on an unspecified date.  The outcome of the events was not resolved.
The arm that the injection was given has hurt since the the injection.  The injection itself wasn't very painful but within two days my upper arm was sore.  That was in May and it's now November.  My arm now hurts constantly and the muscles have become very weak.  I can't use the right arm to lift things or hold anything that is heavy.  I can't use it to pull myself up.  It's difficult to sleep on my side now which is how I have always slept.  I have hesitated to go to the Dr because so many people are negative about the vaccine and it's so political and I don't want to be perceived as one of those people.  I am a supporter of the vaccine and vaccines in general.  I am not a supporter my arm hurting and would like some info if that has been reported and how long it last and if I need to do anything to help improve the situation.
Fever between 100-101 all day apr 6. Fatigue. Large red rash at injection site noticed apr 8, darker at perimeter, approx. 3 inches in diameter. Area is hard, painful, and radiating heat.
member stated she had both doses of covid injection, stated had Moderna injection and after second dose did not feel well for several days, stated reported to doctor, was on couch for 2-3 days, had fatigue and aches and upset stomach, injection site left arm, does not have access to the injection dose card, had injection at May
pt recv vax 22OCT96 & 23OCT96 pt devel vomit & diarrhea w/o fever 48hr p/inj;pharmacist related there were other pt that exp v,d who did not recv flu vax;this is one of 25 cases reported by a pharmacist;
Missed dose; Dizzy; Tingling in hands and feet; Achy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PARAESTHESIA (Tingling in hands and feet), PAIN (Achy) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced DIZZINESS (Dizzy), PARAESTHESIA (Tingling in hands and feet) and PAIN (Achy). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), PARAESTHESIA (Tingling in hands and feet) and PAIN (Achy) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: New event missed dose was added. Outcome was updated for the event pain.
could not walk; COVID-19 like symptoms; every single bone hurts; sore arm; could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could not walk), COVID-19 (COVID-19 like symptoms), BONE PAIN (every single bone hurts), PAIN IN EXTREMITY (sore arm) and FATIGUE (could not get out of bed) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN and PREDNISONE for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (could not walk), COVID-19 (COVID-19 like symptoms), BONE PAIN (every single bone hurts), PAIN IN EXTREMITY (sore arm) and FATIGUE (could not get out of bed). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (could not walk), COVID-19 (COVID-19 like symptoms), BONE PAIN (every single bone hurts), PAIN IN EXTREMITY (sore arm) and FATIGUE (could not get out of bed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (Severe Reaction from the Moderna COVID-19 injection) in a patient of an unknown age and gender 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) at an unspecified dose. On 25-May-2021, the patient experienced VACCINATION COMPLICATION (Severe Reaction from the Moderna COVID-19 injection). At the time of the report, VACCINATION COMPLICATION (Severe Reaction from the Moderna COVID-19 injection) had not resolved. Patient was taken to the hospital by ambulance. No other details provided. Follow-up required. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. According to a social media post, on 25-May-2021, the patient suffered a severe reaction after receiving the Moderna Vaccine and on 22-Jun-2021, the patient was again transported to the hospital by ambulance. No additional reports have been received at this time. Reporter did not allow further contact.
arm pain at the injection site; The injection site itched; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 08Mar2021, patient received the first dose of the Pfizer COVID 19 vaccine and still having arm pain at the injection site. How long does the pain usually last. The injection site itched for a couple days after the shot. Patient was 69 years old. And asking Should he get the 2nd dose. The outcome of the event the injection site itched was unknown. The outcome of the event arm pain at the injection site was not recovered.  No follow-up attempts are possible; No further information is expected.
Information has been received from a published literature article. The patient in this case was a 15-year-old male patient with T-cell precursor acute lymphoblastic leukemia undergoing re-induction chemotherapy. His immunization records from school revealed that the boy had received one varicella vaccination (manufacturer unknown, lot #, dose and route were not reported) when he was 5 years old but none thereafter; he was up-to-date on other vaccines. We defined Day 1, as the day when the patient presented to the Emergency Department for fever and a sharp stabbing back pain. He had blood cultures drawn and received levofloxacin. On Day 2, he presented again with high fever and decreased peripheral perfusion, with prolonged capillary refilling time. Thus, he was admitted to the Pediatric Intensive Care Unit (PICU) and received intravenous antibiotics. Laboratory data on admission showed lymphocytopenia (200 count/mm2). After his general condition was stabilized, the re-induction chemotherapy regimen with vincristine, doxorubicin, asparaginase, and dexamethasone (manufacturer unknown) was resumed. On Day 3, he developed a non-vesiculated acne-like rash, believed to be related to the high dosage of dexamethasone (manufacturer unknown), based on its appearance. On Day 7, the rash started to vesiculate. Vesicular fluid was obtained and Varicella-Zoster Virus (VZV) deoxyribonucleic acid (DNA) was detected with polymerase chain reaction (PCR) analysis. Intravenous acyclovir was started. On Day 9, he developed hepatitis, which subsequently progressed to multi-organ failure and death. DNA analysis of the PCR product from the vesicle indicated that the virus was wild type VZV (5). VZV antibody titers were never obtained. The authors considered the event as vaccination failure and the patient died of disseminated varicella. This is one of 2 reports received from the same literature (other case # 1505USA000527). Additional information has been requested.
Patient received flu vaccine. 2 days later, patient very sleepy and falling asleep in the middle of activity. Oct 2. Pt wake up disoriented and went to her doctor and then she was admitted in Medical Ctr. MRI was done. Pt. was diagnosed with herpetic encephalitis. She received acyclovir IV, via pic line. She spent 2 weeks in hospital and 1 week in rehab. She received physical therapy. She has decreased mental capacity.