chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lost his lost balance a couple of times; Falling towards the left side; Loss of motor skills; Felt like his body froze; Could not move, feet nor body/could not lift himself from the floor; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Lost his lost balance a couple of times), FALL (Falling towards the left side), MOTOR DYSFUNCTION (Loss of motor skills), FEELING COLD (Felt like his body froze) and HYPOKINESIA (Could not move, feet nor body/could not lift himself from the floor) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (not hospitalized) in January 2021. Previously administered products included for Product used for unknown indication: Pfizer (Dose Number: 2) and Pfizer (Dose Number: 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Heartbeats skipped (Heart (skip in his heart)) and Diabetic. Concomitant products included APIXABAN (ELIQUIS) for Heartbeats skipped.   On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Slight fever). On 16-Jul-2022, the patient experienced BALANCE DISORDER (Lost his lost balance a couple of times), FALL (Falling towards the left side), MOTOR DYSFUNCTION (Loss of motor skills), FEELING COLD (Felt like his body froze) and HYPOKINESIA (Could not move, feet nor body/could not lift himself from the floor). On 16-Jul-2022, PYREXIA (Slight fever) had resolved. On 17-Jul-2022, BALANCE DISORDER (Lost his lost balance a couple of times), FALL (Falling towards the left side), MOTOR DYSFUNCTION (Loss of motor skills), FEELING COLD (Felt like his body froze) and HYPOKINESIA (Could not move, feet nor body/could not lift himself from the floor) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Positive.         The patient had no allergies.  The patient was on a bunch of medications but did not provide any names.  Caller stated that the patient who always gets slight fevers with vaccine, but experience after his last Moderna booster. Patient's side affects started on Saturday, 16Jul2022, in the morning and at 2 AM and lasted 1 day.  Adverse event did not caused the patient to seek medical care.  No treatment medications were reported.
SHE HAD A FEBRILE SEIZURE DUE TO FEVER.  PLUS A RASH ALL OVER HER BODY. SHE HAD A COUPLE FEVERS BEFORE AND NEVER EXPERIENCED THIS UNTIL AFTER THIS VACCINATION.
This spontaneous case reported by a consumer, describes the occurrence of asthenia (too weak) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 1, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced asthenia (too weak). At the time of the report, asthenia (too weak) outcome: unknown. Treatment details not provided. This case linked to MOD-2021-013278 (patient link).
Pain at injection site felt after injection in upper left shoulder.  Pain got progressively worse and developed decreased range of motion.  Saw PCP after 4 months.  Referred to Orthopedic doctor who took xrays and who said flu shot had been injected into shoulder bursa instead of into muscle, causing inflammation and "frozen shoulder".  I was given cortisone shot and referred for physical therapy.
Day of 2nd Moderna vaccine Zizzo developed sore throat, loss of taste/smell, headache, myalgia, fatigue, fever/chills.
Information has been received from a physician concerning a "little over 70 years old" male patient with heart disease who either in 2007 or 2008, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number, dose and route not reported). The physician reported that either in 2007 or 2008 the patient developed shingles about 6 days after receiving the vaccine. The patient had some heart issues and had been hospitalized before getting the vaccine. Apparently the ZOSTAVAX (Merck) was given after the patient was released from the hospital but the physician did not know how soon after. Later on an unspecified date about 6 to 12 months after getting the vaccine the patient passed away. The physician reported that he thought the cause of death was the heart disease but he did not know for sure. Additional information has been requested.
14APR94 temp 104.4 ax  home; 15APR temp 104.9 ear @ clinic; rash started; blood work ordered per MD; ATB inject given; dx BOM-poss react to vax given 5APR94; 16APR elevated temp, vomiting, rash cont;
That same evening felt very fatigue, body aches. Next day lots of pain in both for about a week. Diagnosed with Covid 04/13/2022. Went the Chiropractor, he said adrenal glands knee were fatigued and over worked.
Started with severe low back pain on 1/20/21 with no reported injury or trauma.  Pain is constant and severe 7-10/10.  No urinary symptoms.  No prior hx of back injury or chronic pain.  Has not improved in the last 5 days with ice, heat or ibuprofen.
A report was received from a health care professional on 10/29/2003 who is a 26 year old female vaccinee who experienced localized itching and burning at the vaccination site an unspecified length of time after inadvertently receiving Fluvirin subcutaneously on 10/29/2003. It was not reported if the vaccinee had recovered at the time of the report. There was insufficient information to determine the reporter's causality. Follow up pending.
First dose: after first dose, both thumbs went numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 (Lot number: ER8730) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety", start date: Dec2020 (ongoing), notes: Verbatim: Anxiety; "Panic attack", start date: Dec2020 (ongoing), notes: Verbatim: panic attacks. Concomitant medication(s) included: CITALOPRAM taken for anxiety, panic attack (ongoing). The following information was reported: HYPOAESTHESIA (non-serious) with onset 24Mar2021, outcome "recovered" (24Mar2021), described as "First dose: after first dose, both thumbs went numb".  Additional Information: The patient received Dose 2 and Dose 3(Booster) of Pfizer Covid 19 vaccine. No side effects after administration of Dose 2 noted. Patient received Booster dose(Dose 3) of Pfizer Covid 19 Vaccine (Right arm) on 15Jan2022 with a Lot no. FJ1614. Patient experienced a very large whelp around injection site, severe pain in right shoulder and clavicle.  No follow-up attempts are possible. No further information is expected.
11 minutes after receiving vaccine, experienced dizziness and feeling faint.  Then my skin felt like it was on fire and I had excessive itchiness from head to toe.  I had a little difficulty breathing and an elevated heart rate.  I was administered Benedryl by the Pharmacist.  I was observed for over 30 minutes.  I had itchiness for 2 days after the vaccine.  I also experienced  soreness and a headache post injection for a day.
Patient with history of COVID vaccines who admitted to hospital after COVID detected PCR prior to admit.  Provider d/c note:  "48 YO male with PMH Bipolar disorder, DM2, HTN,  who presents to the hospital with complaint of SOB due to anxiety. Labs with elevated anion gap, elevated blood glucose (200s) and low bicarb. Suspected starvation ketosis vs DKA, patient started on insulin gtt and BMP q4H. With D5 NS Kcl infusion initially. As anion gap closed and bicarb improved, patient switched over to lantus and lispro (titrated to lantus 30 units daily and lispro 10 units three times daily). As patient was taking humalin u500 at home, he was on a carb counting dose; however, suspect that current starvation ketosis likely from use on short acting insulin alone without any long acting coverage. Patient has known gastric lesion which GI was consulted on previous admission, but he has not followed up with recommendation to follow up at gastroenterology. He has severe anxiety and mood disorder that limits his functioning. Psychiatry was consulted during this admission and medications were uptitrated (including vraylar 6mg daily, zoloft 100 mg daily and prn olanzapine for anxiety). Currently, stable for discharge. "
Patients mother said that patient developed a bad rash on his right cheek a few days after the vaccine was administered.  They went to the MD to get it looked at and were given an antibiotic.  They later went to the ER and the physician on duty told her it looked like an allergic reaction and prescribed an oral steroid.
One week post vax the pt developed 30 scabbed lesions located on the face, torso and extremities. It was noted that the pt was afebrile. Additional information has been requested.
At injection site right deltoid local swelling size of baseball. Vital signs taken: 70/50  Pulse 52, no SOB, light headed with dizziness. Ice pack applied to site when swelling noted. Juice given. Client placed on exam table after resting for 15 minutes B/P 100/70. Client stated she felt better and left clinic by self.
pt recv vax over the next several days pt exp a h/a for 3-4 days;tx ASA sx resolved;
This spontaneous report was received from a female consumer of unknown age reporting on herself. The patient's medical history, concurrent conditions, allergies or previous drug reactions were not reported. On an unknown date in 2009, the patient received the first dose of GARDASIL, dose, lot#, exp. date, route of administration and anatomical location were not reported. The patient received the second dose of GARDASIL on 29-SEP-2014 (dose, lot#, exp. date, route of administration and anatomical location were not reported. No adverse events were reported. Additional information is not expected, no patient's or physician's contact information is available.
Information has been received from a medical assistant and a physician concerning a 9 week old female who on 05-OCT-2010 was vaccinated with the first dose of ROTATEQ (lot#668334/0515Z) 2 ml pouch PO. Concomitant vaccines included DTAP (manufacturer unknown), HIB (unspecified carrier) (manufacturer unknown), PREVNAR and IPV (unspecified). The patient was premature and born at 33 gestational weeks with birth weight 3 pounds and 14 ounces. On 06-OCT-2010, one day after receiving the first dose of ROTATEQ, the patient developed abdominal distention and had an emergency room visit. The patient was admitted to hospital with a diagnosis of abdominal distention and emesis. A barium enema was performed. Possible "Hirschsprung's" as per the barium enema. A biopsy was performed and was negative for "Hirschsprung's". The patient was given Ampicillin and FLAGYL in the hospital. The patient was recovered (also reported as recovering) and discharged to home on 10-OCT-2010. No final diagnosis was listed in the chart or discharge summary. No further information is available.
This initial non-serious spontaneous case, was received on 05-Oct-2017, from other non-health professional (consumer), concerning a 04-year-old male child. The patient's concomitant medications and medical history was not provided. On an unspecified date, the patient was administered with FLUAD (dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that FLUAD which should be administered for people above 65 years old, was given to a 4-year-old child (explicitly coded as inappropriate age at vaccine administration). The reporter considered this event as non-serious.
No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No concomitant medications were reported. It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. 77 Monovalent doses administered after the BUD to patients 12 and up. It was reported that 37 doses from Lot 059H21A, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A were administered. No treatment information was provided.
Patient got 5 doses of Moderna covid-19 vaccine. Dose #4 (7/14/22) and 5 (8/11/22) were given in full ( 0.5 ml). No adverse event was reported from patient. Pharmacy found out patient has gotten 5 doses upon billing processing.
Flu like symptoms, chills, shakes, sweats. Run down feeling, tired. Treatment, motrin, tylenol
her arm hurt a little bit, was sore with both vaccines; she got covid Jul2021; she got covid Jul2021; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (COMIRNATY formulation: solution for injection),  via an unspecified route of administration, administered in Left Arm on 02Apr2021 (Batch/Lot Number: E2613, expiry date: unknown) as dose 2, single, and received bnt162b2 (COMIRNATY formulation: solution for injection),via an unspecified route of administration in Left Arm 12Mar2021 (Batch/Lot Number: ER6205 , expiry date: unknown) as dose 1, single for COVID-19 immunisation, lung neoplasm malignant, leukaemia, diabetes mellitus, cardiac disorder, and immunodeficiency. Medical history included ongoing leukaemia, ongoing lung neoplasm malignant ,  and neoplasm malignant. Other Conditions: Commented she is  a cancer patient, has  a couple different cancers diagnosed about 3 yrs ago ,well that's how long she has known. One place knew long before, but never informed. Concomitant medication(s) included topiramate (TOPAMAX) 100mg twice a day taken for seizure. On Jul2021 the patient reported she got covid jul2021 (covid-19), and her arm hurt a little bit, was sore with both vaccine. She has not gotten booster dose yet. She tested positive for covid in Jul2021. She came home from 18Jul2021 and was diagnosed with Covid around 19Jul2021 or 21Jul2021. On unspecific date in Jul2021 the patient underwent lab tests and procedures which included sars-cov-2 test (home test): positive, on unspecific date sars-cov-2 test (pcr): unknown result. She called the doctor and told tested positive with home test. Then she went in for the PCR test so could get Monoclonal antibodies infusion because that was the only way could get it. When she called they could tell she was not sounding like herself. She was sounding rough, it was effecting her. Her lungs were hurting. It took 2-3 days of breathing treatments to kick in. The events resulted in physician office visit. She cannot get the flu shot yet because her arms hurt so bad. Therapeutic measures were taken as a result of she got covid jul2021 (covid-19), she got covid jul2021 (vaccination failure) includes Monoclonal antibodies infusion because it was the only thing that helped. She added, the doctor also gave her breathing treatment, antibiotics, and cough syrup. she is supposed to wait 90 days after the Monoclonal antibodies infusion before getting the infusion. That is why she has not gotten the booster yet because if she got it before she could sicker. The outcome of the event was unknown.   Follow-up attempts are completed. No further information was expected.
Shingles outbreak; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 08:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic to sulphur. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. 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.  On 28Apr2021 at 22:00, the patient had shingles outbreak. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event shingles outbreak and included treatment with valacyclovir (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles outbreak was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
received a first dose of Shingrix a year ago and then the patient did not received the second dose after 2-6 months; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received a first dose of Shingrix a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received a first dose of Shingrix a year ago and then the patient did not received the second dose after 2-6 months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-MAY-2023 The pharmacist called to ask for information about the patient who did not receive the 2nd dose after 2 to 6 months. The health care professional asked if the patient had to restart the vaccine series. The reporter did not provide the patient information nor data about the first Shingrix dose. Till the time of reporting the patient did not receive the second dose, which led to incomplete course of vaccination. The follow up request was not requested during the call.
Red hive, sore left arm, spot warm to touch and itchy. Feel like a tightening on my arm like a blood pressure cuff
Chest pain, pericarditis. Onset 1/19/2022. Elevated troponin. Rx: NSAIDs, pediatric cardiology referral.
Approximately 1-2 weeks following my first vaccine I had an episode of Vertigo that effected my balance when I got up in middle of the night to use the bathroom. I did not experience any additional symptoms and fell back to sleep. Last night around 7:30pm I was sitting up in bed and all of a sudden I had what I would descrbe as vertigo and felt nauseated. I turned on my side where I felt better but I fjust felt unwell. I  also had a rapid pulse at the same time. I was OK as long as I did not move.  That continued for about 3-4 hours. Approximtely 20 years ago I had the same issue once was seen in an emergency room. I was diagnosed at that time with menieres and was given a prescription or two.
Reason for Hospital Admission (Admitting Diagnosis): Heart Block/COVID Pneumonia   Hospital Course and Significant Findings: 75 Y male with hx of HFrEF (EF: 20%), HTN, anemia, seizures (not on antiepileptics), hx of renal calculus s/p ureteral stents and subsequent removal who presented with shortness of breath, weakness and diarrhea and was found to have AKI, 3rd degree AV block which was diagnosed on 9/5/2021 and COVID diagnosed on 9/3/2021.   Dual chamber ICD placed on 9/9 by Dr. (couldn't get coronary sinus lead in so only RV pacing now).  Reattempt LV lead placement is scheduled on 10/18 with Dr. . Stopped heparin gtt and start BID Eliquis (2.5mg BID - discussed dosing with pharmacy) Weight up (standing weight 201lbs today and recorded 188lbs on 9/6), BNP is up, oxygen requirement up today.  CXR looked a little better (intermpretation complicated by recent COVID diagnosis).  BP is soft (SBP low 90s).  Cr and BUN up.   D/w Cardiology who recommended start hydralazine, start dopamine gtt, resume Lasix, and consider repeat echo giving finding of dissection of coronary sinus on recent pacemaker placement.     With regard to COVID, symptom onset 9/3/2021. COVID positive on 9/3/2021. He remained afebrile.  He completed 5 day course of remdesivir and was continued on daily decadron.   He was not requiring much oxygen, about 2 to 4LMP via NC and appears well without tachypnea. He had a mild dry cough. He is speaking in complete sentences without cough or tachypnea during my exam.  - No hypoxia on 9/11, even with activity, but on 9/12 was a bit hypoxic so was on supplemental oxygen.    NONTRAUMATIC AKI on CKD. BUN and Cr increasing.  BP was low and CXR looked better but other findings concerning for increasing heart failure.  See above for recommendations from cardiology.     AMS / Delirium.  Due to metabolic and hypoxemic encephalopathy.  Fluctuated and occurred the first couple of days during the night.        Overnight in the early hours of 9/13, his respiratory status deteriorated.  He required increasing oxygen, was seen by cross cover.  He started coughing up bloody frothy sputum.  Required high flow oxygen.  Unfortunately he went into PEA arrest in the morning on 9/13.  Required CPR, was resuscitated, intubated and transferred to the ICU.  Bedside echo showed diminished EF, no pericardial effusion or tamponade.   Per ICU note, "Significant metabolic acidemia an refractory PEA despite initial ROSC and complete resuscitation. Finally, patient was prounced dead at 11am on 9/13."   Cause of death: Hypoxic respiratory failure from COVID pneumonia and ischemic cardiomyopathy.  Primary Procedures:  Procedure(s): CARDIAC AICD TOTAL SYSTEM IMPLANTATION, BIVENTRICULAR CHAMBER
When data entry nurse went to enter vaccine into the immunization registry, learned that the resident had previously received a dose of the Pfizer Covid vaccine on 12/28/20, despite the consent form stating she had never received the covid-19 vaccine.
Donor's left arm hurt the whole time but she noticed it becoming worse on the 5th day and is now burning and stinging. Applied cold pack last night.
Inconsolable scream and crying, high fever, nursing strike, scar at injection site (left thigh)
Pt recvd MMR on 24APR91; began running fever on 30APR; On 1MAY fever 104.9; convuls; Taken to ER, flaccid on arrival, vomited; probable viral infect;
There is no adverse event reported, she received another booster BIV within 3 weeks in an error.
SIGNS/SYMPTOMS - SWOLLEN, RED, ITCHY, WARM, RASH ON ARM. SHE IS FEELING WARM, TOOK MOTRIN 30 MINUTES BEFORE SHOT. SHE HAS HAD THIS SHOT BEFORE AND HAD NO REACTIONS. SHE WENT TO HER PCP TO HAVE IT CHECKED OUT.