chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A nurse reported the occurrence of abdominal cramps in a 39 y.o. female who was vaccinated w/Hep B vaccine recombinant (Engerix-B) for prophylaxis. During the subject's last pregnancy she was "labeled as a Hep carrier". An unspecified Hep A titer was negative and an unspecified Hep B titer was >2 (units and reference range unspecified). Concurrent medications included birth control pills (NOS), loratadine (Claritin), fluoxetine (Prozac), formoterol fumarate (Foradil), and levothyroxine sodium (Unithyroid). On 8/13/02, the subject received her 1st injection of Engerix-B (lot ENG530348; expiry 11/22/03). On 8/14/02, she experienced abdominal cramping and diarrhea. As of 8/16/02, the events were ongoing, but medical attention was not required. Comment: The reporter indicated that the subject received lot ENG530348; however, this is not a valid Engerix-B lot #.
Headache, nausea, body chills and fever intermittent, extreme fatigue all began around the same time, took Tylenol and wet rag on forehead
Broke out in hives 10 mins following the vaccination. I was itching all over and then I passed out. The rescue squad came by and did an EKG and checked my pulse. I took Benadryl every 6 hours, and the hives went away the next day.
Pt had pain in both arms, back pain, dizziness, headache, nausea and vomiting the evening following her immunizations.
At time of shot, felt stinging pain in the elbow and wrist of  left arm, later 5 mins. At some point the next day, I developed Spinal pain. Pain in SI joins, several distinct spots along the spine and the base of my skull, spinal stiffness, difficulty touching knees or putting chin to chest. Lasted 2 days. Night of 3/292021, I woke up with tooth pain  in multiple teeth on both upper and lower and right and left sids of mouth.  Pain great enough to wake me up and caused difficulty returning to sleep, after 600 mg ibuprofen, able to get to sleep and completely gone in the am. Starting 3/30, pain along nerve paths in upper right side back around scapula, felt like burning, intermittent. Now resolved to tingling / numb feeling and some tingling / decreased sensation in upper lip left side and under eye left side
This is a spontaneous report from a Pfizer sponsored program. A contactable physician reported for a 71-year-old female patient received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced drug allergies: PCV 13 on an unspecified date. Outcome of the event was unknown. Information on lot number, batch number and expiration date has been requested.
7 y.o. female with no significant past medical history who presents to the hospital on 9/11/2022 with abnormal gait after recent febrile illness. The abnormal gait was first noticed by parents on evening of 9/8 after an ED visit for recurrent emesis. Dad described it as unsteady and taking wide steps with complaints of dizziness. Since then, the gait stayed the same up until this morning, when he noted some improvement with first 5-6 steps until she is unsteady and wide-based again. Dad stated that Mom also noted her speech has slowed but is non-slurry and understandable and she is able to answer all questions appropriately. No complaints of headache, ear pain, vision changes, diarrhea, vomiting, incontinence, or sensory deficits.    Patient received the 2nd dose of COVID vaccine on 08/20 and developed URI symptoms on 8/22 when she was diagnosed with RSV. Patient was febrile up tp 102-103 on 9/1 and was found to have UTI. She was given Cefdinir and Dad noted that she was very sleepy afterwards. Dizziness and abnormal gait was not seen then. In the ED on 9/11, head CT showed no intracranial pathology    She presents from ED to us on 9/11  with ataxia and dysarthria with areflexia in patellar and achilles reflexes. Labs and imaging so far have been unremarkable, however, per exam findings, this is concerning for early atypical Guillain-Barre Syndrome.    Although she has normal LP and L spine MRI findings however index of suspicion is still high given degree of ataxia (specifically sensory ataxia). Cytoalbuminologic dissociation is not always present especially if early in the disease course. Given speech changes and mild degree of encephalopathy also important to consider GBS variants such as Miller-Fisher variant.    Given her presentation an acute etiology such as stroke (ischemic vs hemorrhagic) and large space occupying tumors were important to rule out. Of note, her MRI brain showed some punctate T2 hyperintensities that seem unrelated to her current presentation. Her MRA of her head did show some possible abnormalities in her posterior circulation however unclear what this represents.
100 degree fever, body aches, chills, insomnia overnight. Other symptoms still persist . I was unable to work today as scheduled due to these symptoms.
This spontaneous report as received from a Nurse refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 09-JUL-2004, the patient was vaccinated with an improperly stored dose of M-M-R II. On 20-JUL-2004, the patient was also vaccinated with an improperly stored dose of VARIVAX. On 29-JUL-2004, the patient received the second dose of M-M-R II and VARIVAX. Both vaccines were reconstitute with a sterile diluent (STERILE DILUENT), which was unknown if was properly stored (dose, route, lot numbers and expiration dates were not reported) all for prophylaxis. No adverse effects reported.
Initial symptoms (night of and day after) were as expected- headache, body aches, joint pain, slight fever and swollen lymph node in right arm pit. This was exactly like what I experienced after my second COVID shot.  What concerned me was two days after, 11/13/2021, I nearly blacked out that evening. My resting heart rate was mid 70s, but standing up caused it to reach 120s. It would remain in the 100-115 range until I laid down again. I've been suspected as having mild POTS before this, but this was extreme. I spent the next week confined to my couch. I couldn't get up to move around for more than a few minutes without feeling presyncope and nauseated. Eating produced the same symptoms. Lying down I would feel normal. It has slowly, slowly, been resolving this past month with home remedies like extra fluid intake, chicken broth in the AM, compression socks, resting, etc. I am still not 100% back to where I was before, but I am hopeful because it is trending in the right direction at least.
11:50  reported dizziness b/p 112/88 pulse  12:11 dizziness gone b/p126/78 pulse80
Narrative:  52 yo male patient with Metastatic Colon Cancer died during inpatient hospice stay on 11/30/2021. Pt had received covid vaccines on 2/18/21 & 3/11/21. Death is not related to vaccines.
Pt recvd 2 doses of Engerix-B 22OCT92 & 20 mins p/vax vomited,  had diaphoresis, h/a, muscle pains & sl chest pain; reporter indicated pt may have allergic reactions; pt taken to ER;
Trigeminal neuralgia 1 day recurrence post vaccine. Had not had this for 6 years (was post viral)  Word groping for 1-2 hours day after 2 nd vaccineCould not say what I was trying to. Same as post virus occurrence of 6 years ago.
patient came in on Tuesday 12/17/19 reporting hives on upper right arm.  she showed Pharmacist the hives. they were not directly at injection site but in the general area of injection site.  Patient had 2 hives (red raised wheals).  she stated they weren't that itchy but she could notice them.   Pharmacist recommended taking antihistamine, patient reported that she takes daily zyrtec.  Pharmacist stated she could add oral Benadryl if needed.  Pharmacist also recommended topical hydrocortisone, patient reported she had topical clobetasol at home she could use if needed.  Pharmacist recommended that patient notify her MD of reaction so they could notate in her chart as they may not want to repeat the dose after age 65 when she is due again.  patient called back and told me she did notify her doctor's office for them to update her chart.
PFizer vaccine received 3/23/21, 4/13/21, 9/15/21 CHIEF COMPLAINT Cough, SOB, Hypoxia COVID Infection   HISTORY OF PRESENT ILLNESS Pt is a 59 y.o. female with a background history of follicular lymphoma on treatment with rituximab, recent COVID-19 infection requiring hospitalization from 10/03 to 10/6-during this admission patient was treated with remdesivir and convalescent plasma, osteoarthritis. Patient was vaccinated with Pfizer and received booster.  She did not require oxygen after her admission with covid.     The patient never really improved since her COVID infection she had persistent shortness of breath and shortness of breath on exertion and low-grade fevers with chills.  She also com  Additional information for Item 18:  CHIEF COMPLAINT Cough, SOB, Hypoxia COVID Infection   HISTORY OF PRESENT ILLNESS Pt is a 59 y.o. female with a background history of follicular lymphoma on treatment with rituximab, recent COVID-19 infection requiring hospitalization from 10/03 to 10/6-during this admission patient was treated with remdesivir and convalescent plasma, osteoarthritis. Patient was vaccinated with Pfizer and received booster.  She did not require oxygen after her admission with covid.     The patient never really improved since her COVID infection she had persistent shortness of breath and shortness of breath on exertion and low-grade fevers with chills.  She also complained of ongoing cough with clear sputum she reported dull chest tightness and pain that is nonradiating not worse on exertion, does no palpitations no diaphoresis no paroxysmal nocturnal dyspnea and orthopnea and no swelling of the lower limb.  She did not describe any pleuritic chest pain on any tender.   On presentation to the floor she was hemodynamically stable but requiring 3 L of oxygen via nasal cannula
pt recvd vax 1NOV95 & 9NOV95 pt who was the 4th of 5 children, whom all had natural chickenpox, devel 3 chicken pox lesions on face;No further details were provided;
Pfizer-BioNTech COVID-19 Vaccine EUA Day 1 (injection day): mild headache, some light-headedness, tenderness near injection site Day 2: very sore upper arm, typical of IM injection, noticed rash on underside of left arm Day 3: rash observed by 2nd person, mild itching, small bumps from armpit to elbow on underside of my arm. Day 9: rash still present.  No change. Itching mild, but still present.  No other symptoms noted.
Received First Dose and Currently Breastfeeding; Initial Report Received on 05-Aug2022  A patient reported that she, a 32 year-old female (race and ethnicity not provided), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while breastfeeding.  Relevant medical history and concomitant medications were not reported at the time of report.   On 04-Aug-2022, the patient, who was currently breastfeeding, received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, and injection site not reported) intramuscularly. The patient did not wish to share any further information.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Non-Serious Down Syndrome; diabetes; 14 Inches Long Blood Clot in the Femoral Brain; Blood Clot; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2K-163-4265157-00.  A 19-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 18 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE: 1, Route of Admin: Intramuscular), administration date: 09Mar2021, when the patient was 18-year-old, for COVID-19 Immunization. The following information was reported: THROMBOSIS (disability) with onset May2021, outcome "recovered", described as "Blood Clot"; CEREBRAL THROMBOSIS (disability) with onset 29Jun2021, outcome "recovering", described as "14 Inches Long Blood Clot in the Femoral Brain"; TRISOMY 21 (disability), outcome "unknown", described as "Non-Serious Down Syndrome"; DIABETES MELLITUS (disability), outcome "recovering", described as "diabetes". The action taken for adalimumab was unknown. Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab) The reporter's causality for the event(s) of disabled, 14 inches long blood clot in the femoral brain, blood clot, down syndrome, diabetes was not provided. Company's opinion is that there is no reasonable possibility that the events of disabled, 14 inches long blood clot in the femoral brain, down syndrome, diabetes are related to Humira (Adalimumab). Company's opinion is that the event of Blood Clot is not assessable. Causality for vaccine Clot blood (Thrombosis) Causality as per reporter (Drug/Vaccine): Possible.  The reporter's assessment of the causal relationship of "14 inches long blood clot in the femoral brain", "non-serious down syndrome" and "diabetes" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "blood clot" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available clinical data, reported events were most likely from an intercurrent medical condition considered unrelated to vaccination with BNT162B2. This case will be re-evaluated upon receipt of additional information.
After the first vaccine I experienced some pain on the left side of my neck into my jaw.  The day after the second vaccine I noticed a lump above my left clavicle.  That evening the lump was larger and visible.  The next day the lump became even larger and at one point the swelling in my neck seemed like it might impede my airway.  After using a warm compress the swelling came down a little.  I called the on-call doctor who recommended a follow up in the office.   It wasn't until 2 days later that it wasn't visible anymore but could still be palpated.  I had an appointment with my physician on Tuesday just to make sure it was a swollen lymph node.  She advised it was soft and moveable and most likely a swollen lymph node but to keep an eye on it and if the swelling didn't go down in two weeks to get further testing.
A few days following the vaccine the patient experienced sweating, chills, and full body soreness. Went to the doctor 4.10.18 and was diagnosed with an infection ("high WBC count"). Was prescribed Cefdinir 300mg BID for 10 days.
Intradermal Flu Vaccine Adverse Event: Erythema at the injection site. Swelling and pain at the injection site. A large nodule forming at the injection site. Red rash at the injection site. There were another 30 hospital employees that have reported the same adverse event.
out of 35 vaccines, this is 1 of 3 pt from this site to exp lightheadedness, dizziness, & weakness w/in min of vax;
kappa/lambda ratio was .09 which is way out; This spontaneous case was reported by a consumer and describes the occurrence of LIGHT CHAIN ANALYSIS ABNORMAL (kappa/lambda ratio was .09 which is way out) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and D11A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced LIGHT CHAIN ANALYSIS ABNORMAL (kappa/lambda ratio was .09 which is way out). At the time of the report, LIGHT CHAIN ANALYSIS ABNORMAL (kappa/lambda ratio was .09 which is way out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Immunoglobulins: .09 (abnormal) Patient had a blood work 5 months after the second dose of the vaccine (in August 2021) and in it his kappa/lambda ratio was .09 which is way out..         No concomitant medications reported by reporter No treatment medications provided by the reporter.  They went through scenarios and the only thing he can think of is maybe the vaccine did it. He's looking to do a booster and wants to be sure he won't have trouble and if the vaccine could interfere like this.
Swollen lymph node in left armpit, sore to the touch - noticed this morning in the shower - as of 4 pm today, pain still hasn't subsided and size of swelling has not increased, nor decreased.
Received Gardasil and Menactra on same day 3/13/07 at a routine physician. Approximately 12 hours later, she began with fevers, chills, headache, dizziness, sore throat & abdominal pain, vomited x 1
Parasthesia in bilateral hands and feet, weakness in extremities, slurred speech parasthesia of lips/mouth, vision changes, back pain, pain in bilateral arms, mood changes.
Initial solicited report received from a consumer (online market research respondent) in the study  on 04 December 2015. The subject (gender and age were not reported) felt very bad reaction and had to go to urgent care on an unspecified date, three hours after receiving a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (date of vaccination, site and route of administration and batch number were not reported). During a prompted discussion the subject reported that, the vaccination of high dose to seniors were giving without telling to them. It was reported three years later, the subject experienced very bad reaction and had to go to urgent care. They did not know if the subject could ever had the flu shot again. They called to the subject and told that they were giving the high dose to all seniors. The lab data and corrective treatment details were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
8/8/07 developed band-like tightness to abdomen.  This continued and resulted in hospitalization 8/20 - 8/23.  He was noted to be hyponatremic with sodium of 126.  On 8/23, he developed numbness and tingling in right hand, progressing into both hands.  By 8/25, he noted numbness and tingling into both feet.  By 8/27, he was complaining of dizziness and weakness.  He was readmitted to hospital on 9/01.  He was discharged on 9/5 with diagnosis of constipation and peripheral neuropathy.  I saw him on 9/11 and readmitted with profound weakness.  He was diagnosed with GBS on 9/14/07 by way of CSF.  He stayed in the hospital for 16 days and was D/c'd on 9/30.  He was readmitted 10/19 - 10/22 with recurrent symptoms and diagnosed with CIDP.  He is doing well at present, but undergoing long-term therapy with prednisone, monthly Igg influsion, and close monitoring 1/8/08-records received-DC summary for DOS 9/1-9/5/07-C/O progressive constipation for 1 month. GI consult evaluation constipation related to milrinone. DC summary for DOS 9/11-9/18/07-C/O abdominal pain, nausea and vomiting. Decreased sensation to light touch, pinprick and vibration, no reflexes, DX: Guillain-Barre. Treated with IVIG. DC summary for DOS 10/4-10/5/07-Chest pain likely secondry to atrial fibrillation secondary to rapid ventricular rate.  After follow up, this case was determined to be Chronic Inflammatory Demyelinating Polyneuropathy, and not GBS. 1/15/2010 Paitent continues to have some weakness to lower extremities, he continues to be seen in the neurology clinic for ongoing, tapering Prenisone and continues on mostly infusion of Immune globulin. His disability is minimal at this time.  02/02/2010 He is recovering-he continues on Prednisone but has been receiving IVIG monthly.
8PM on 4MAY93 started crying & could not be consoled; did this to 11PM;
Feeling faint and then passing out upon trying to go about normal routines the morning after vaccine.
Shortness of breath, chest pain and muscle soreness over left chest fast heart beat on and off still lasting 3 days later.
she was told that 9 players and the coaches of the baseball team all came down with covid; she was told that 9 players and the coaches of the baseball team all came down with covid; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program . This case is for a patient (Player #6). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced "she was told that 9 players and the coaches of the baseball team all came down with covid". It was reported that Player #6 of the baseball team came down with covid. The reporter wanted to know why this happened and she stressed that the vaccine is supposed to save you from getting covid. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on this specific patient. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Outcome of the events were unknown.   Information about lot/batch number has been requested.
Information has been received from a nurse (also reported as Certified Medical Assistant) referring to five unspecified patients of unknown age and gender. On 11-JUL-2015, the five unspecified patients were administered MMR II which underwent a supported temperature excursion. No adverse effects reported. Additional information has been requested.
Mat 14,2021 Right hand lost feeling, watering hose fell from hand, fingers and wrist swollen. Extreme pain in right thumb. would scream if it had any movement Immediately went to local urgent care facility
1st shot: No adverse reactions after the shot. 2nd shot: 3 minutes after the second shot, felt warm wave in my body and became dizzy. Did not have additional side effects and left in 20 minutes. During driving back and 1 hr after the vaccination became even more dizzier and fatigued, with walking balance issues. Second day dizziness disappeared, but I had a pain in the area of the shot, headache, body aches, and fatigue, balance issues. 3rd day started recovering.  3-8 day side effects gradually disappeared but started having panic attacks and generalized anxiety which I suffered years ago.
Vasovagal rxn - felt faint, dizzy, sweaty Wheelchair to gurney, monitored vitals, H2O Started 1325 Resolved and discharged at 1345
Attending Physician: (Privacy); Primary Care Physician: (Privacy)   Date of Admission:                                                4/2/2022       HISTORY   Chief Complaint: Bladder discomfort   Sourceof Information:  Patient and Available medical record   History of Present Illness:  This is a 61y.o. female who presented to the hospital with bladder discomfort.  Patient states she has been having urgency with sensation of urinary retention for the past couple of days, progressively getting worse.  Denies fevers, admits to chills.  Denies burning on urination.  No associated back pain.  Patient states that she called EMS because she was afraid she was going into septic shock. While in the hospital patient was having suicidal ideations.
Patient was given Pfizer-BioNTech booster monovalent after Sept 1, 2022 when biovalent  booster was approved.