chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First shingles shot in 2019, second 2-2-22; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st shot in 2019).   On 2nd February 2022, the patient received the 2nd dose of Shingles vaccine. On 2nd February 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient received a dose of Shingles vaccine later than the recommended interval, which led to lengthening of vaccination schedule. The reporter asked does that counts and that if he/she was protected. The follow-up could not be possible as no contact details were available.
Fever; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (Fever) 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) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Patient was supposed to receive 1st dose of COVID-19 Pfizer monovalent (Comirnaty), but was given the COVID-19 Pfizer bivalent.
Pt c/o Trismus onset <24 hrs after vaccine admin Sx progressing to numbness, weakness to left side. All labs, WNL, CT negative.
Patient came in 9 days post injection. She had complained of severe myalgia which was continuing. Also, she had swelling in arm. The area was "hard" to touch. Recommend physician visit.
Encountered patient on the ground in the waiting room blacked out after receiving Johnson and Johnson vaccination at 11AM 07122021.  Patient regained consciousness while I was on the phone with 911.  Patient immediately said that she was OK.  She said she felt like she was going to black out so decided to lay on the ground to prevent any injury.  She mentioned at that time that she had a history of blacking out.  Patient was assessed for breathing, color changes, injury as per 911 instructions while awaiting paramedics.  Paramedics assessed patient and concluded that patient had normal vital signs and no other issues of concern and was allowed to go home.  Patient did not receive any treatment
Productive cough, fever, chills, body aches given Tylenol and antibiotics.
Apprx one month after my second Moderna dose, I woke up one morning with massively swollen fingers, several of which I was unable to bend/move.  My fingers ached; I couldn't get rings on or off, and had trouble typing. This continued for several days but gradually improved; my fingers were back to their normal size and pain was gone within a week.
Sore lymph nodes in underarm area still on day 5, slept for 11 hours, cold/hot flashes, cold sore emerged in center left of lower lip. Haven't had a gold sore in over 25 years. Left foot is tender so a bit wobbly walking wise. No treatment for lymph nodes or tiredness. Just rest. Will pick up abreva for cold sore. possibly physical therapy for foot to be discussed with doctor.
So, my arm was/is sore. I got an instant headache after the shot. The rest of the day wasn?t too bad. When I got up yesterday morning I felt like heck. Like a 25% covid. After about 1pm I literally slept the rest of the day. I woke up today feeling tired but otherwise ok.
This spontaneous report as received from a 52 year old male patient reporting on himself. Medical history and concurrent conditions were not reported. In November 2014 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous. Dose, frequency, lot number and expiration date were not provided. No other suspect or concomitant therapy was reported. The patient stated that since that time he had experienced intermittent bouts of rashes on his back, legs, back of legs that appears and then disappears. The outcome of rash was unknown. The causality between the therapy with ZOSTAVAX and the event was unknown. Additional information has been requested.
Mild headache and right arm discomfort starting 1 hr after shot which gradually increased to significant whole arm pain. At 9 hrs past injection I had strong miserable flu like symptoms which interfered with sleep which lasted a couple hours. By hour 18 I was still feeling sick and sluggish. By 24 hrs flu symptoms were gone but my deltoid still felt punched. At 48 hrs my deltoid is still sore to touch. I never had redness near the injection site. I considered taking TYLENOL but never did. I did not take my normal vitamins on 2/16 because I felt lousy.
12/01/2001 1 AM low grade fever, 20 minute episode of lip smacking, eyes rolling up, slight stiffness of extremities, unresponsive to environmental stimuli. Seen in ER diagnosed with seizure.
This was a Booster - it might be helpful to add that to the dose drop down.   Approximately 2 hours after the booster I started to get the "fall asleep" feeling in my upper torso and lower face. Not full numbness, a little tingling. Not painful like when your foot gets blood rush to it just the asleep tingly feeling.   Parts that stuck on for me - both biceps, collar bone area, fingers, jaw and cheeks.   I called a medical facility and got an appointment fairly quickly in the urgent care. I am unfamiliar with the doctor that I saw so wasn't able to provide that in my report.   He checked all my vitals, asked a lot of questions and ultimately decided that my body was aggressively reacting but didn't have any other worrisome symptoms like shortness of breath. Symptoms lessened in a few hours, but did extend down to thighs (quad area). Tingling  feeling would come back randomly for 36 hours. Then did not occur.  I had symptoms at 12 hours post booster- body aches and chills which mirrored reactions to my second dose of Pfizer. I hold those as normal side affects and completely separate from the above.
Child received vaccine on 7/19/2010 - called 7/22/10 and stated (L) arm red, warm to touch. ADVIL and ice to site by mother Monday 7/19/10 and 7/20/10.
Case number PHEH2013US017751 is an initial spontaneous report received from a nurse on 19 Aug 2013 with a follow-up received on 24 Sep 2013: This report refers to an adult male patient. He was given only MenCYW liquid conjugate component and MENVEO (batch number: M11073) intramuscularly in to the left arm on 16 Aug 2013. No adverse event was reported following this administration error. He was vaccinated with the correctly re-constituted vaccine on 18 Sep 2013. Follow-up received from the nurse on 24 Sep 2013: Updated patient demographics, site of application of MENVEO and information about revaccination with the correctly re-constituted MENVEO.
A non-serious spontaneous report of patient was given expired FLUMIST was received from a health professional concerning a 16-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. On 15-Feb-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 at 18:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid removed" (unspecified if ongoing), notes: Thyroid removed; "breast cancer" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "cholesterol" (unspecified if ongoing), notes: cholesterol; "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient took anti viral product: COVID-19 treatment, start date: 16Aug2022, stop date: 21Aug2022, lot number: Unknown, indication: Treatment of Covid-19. Yes the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment and the patient previously receive a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Complains of slight fever 100 degrees and 1 time vomiting. No other symptoms at this time.
Employee received her 2nd Pfizer vaccine on 1/12/2021.  Twelve hours later she developed a fever with a T-max of 102 degrees.  The fever lasted 18 hours.  She also complained of severe malaise and fatigue lasting 36 hours.  On day 3 she developed left lower extremity pain that persisted over the weekend.  She was seen in Urgent Care today where she was diagnosed with a thrombosis. She also came to the ETC and was ruled out for a PE The employee does have a family history of antiphospholipid in her mother. She has a follow up with her PCP and will also receive a work up in hematology as she had never been tested for any genetic coagulation conditions after her mom's diagnosis.
On July 15, 2022 I started feeling nauseated, coughing more than normal, my nose was running, excess mucus. On July 17, 2022 I tested and had a temperature of 101.6F and diarrhea for two days. I did not lose my sense of smell of taste but my appetite decreased. I picked up an over the counter decongestant when I got tested. I quarantined until July 26, 2022. I feel that I have recovered one hundred percent.
Hives lasting 3 hours developed 8 days later on Saturday, March 6, 2021.
Pain in my arm, fever and pain on the next day, feeling sick, weak and tired with still mild pain in my body on the third day. reported submitted letter indicated that the reactions to the Menactra shot lasted for two days, felt achy pained and very very tired. After the two days, however, the symptoms subsided. Feel fine now.
Pt received the DTap/Hep B/IPV instead of the DTap only. Pt tolerated injections well with no side effects following injections. Pt was in office for 15 minutes post injection. Pt received additional dose of the IPV due to this error. No other adverse reactions reported.
Patient received an extra bi-valent booster vaccine. His vaccine card was marked as "Pfizer 10/04/2022" rather than "Pfizer Bivalent 10/04/2022". Therefore, we knew he was 2 months out from his last dose, but it was Pfizer bivalent rather than monovalent.
Pt reports 1 hour after receiving flu vaccine began to experience significant body fatigue and lightheadedness/dizziness. PT followed up about 4.5 hours after vaccine and was evaluated in office (normal exam, VS, BG). Reviewed red flags/precautions for immediate follow up in ER and was driven home by husband. No previous adverse reaction.
Date of Admission / Date of Discharge / LOS  10/10/2022 / 10/12/22 / 2 Days Discharge Diagnoses   Active Hospital Problems   Diagnosis o Principal Problem: Hyponatremia o PAF (paroxysmal atrial fibrillation) o Atrial fibrillation with rapid ventricular response  o Hypomagnesemia o COVID o Coronary artery disease involving native coronary artery of native heart without angina pectoris     Overview Note:     Non obstructive CAD   o SSS (sick sinus syndrome)      Overview Note:     Sinus pauses 5-6 seconds; dual chamber pacemaker implant 12/21/17   o S/P placement of cardiac pacemaker     Overview Note:     Medtronic MRI SureScan Advisa A2DR01 model implant performed by Dr.  o Atrial tachycardia, paroxysmal     Overview Note:     On bystolic and flecainide. Eliquis for AC.   o Type 2 diabetes mellitus without complication, without long-term current use of insulin  o Mixed hyperlipidemia o Essential hypertension
Significant rashes/hives. Come and go randomly. Treatable with Allegra.
4/6, Father reported rash from top of hand up back and front of arm. BENADRYL x 3 days until resolved. 4/7, Spoke with Mother. Mom said applied BENADRYL an cortisone cream the evening rash started. 4.7, Mom advised to do a nurse visit in future if SXs again after inj.
Initial unsolicited case received from a physician on 26 October 2016. This case involves a 79-year old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, dose number form, route and site of administration) on an unspecified date. Patient's medical history and concomitant medications were not reported. On 26 October 2016, two hours post vaccination, patient experienced slurred speech and other signs of TIA. Laboratory data and corrective medications were not reported. Outcome of the event were not reported. Upon internal review, the company decided to consider the event serious because of important medical events' TIA and slurred speech. List of documents held by sender: none.; Sender's Comments: Transient ischaemic attack is unlisted with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Time to onset is compatible with the role of the vaccine. This is poorly documented case. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Admit for rapid Afib and positive COVID test, without pna. Fully vaccinated "5 months ago". Vanc, eliquis, vit-c, zithromax, rocephin, vit-D, zinc. Did not require O2. Improved and d/c home with HHC.
Information has been received from a pharmacy technician referring to a 74 year old male patient. The patient's medical history included prostate cancer and hernia repair in past. The patient's concomitant medication and concurrent conditions were not provided. On 18-SEP-2012, the patient was vaccinated with ZOSTAVAX (strength, dose, lot number, expiration date and administration route were not provided). On 2015, the patient experienced a mild case of shingles. The outcome of herpes zoster was reported as recovered/resolved on an unspecified date. No product quality complaint (PQC) was involved. Additional information is not expected because the reported refused additional contact.
On 11/5/21, patient started having sore throat. On 11/8, he started having fevers, rash involving knees, palms, and soles as well as non-bloody vomiting. He was admitted to the hospital on 12/11 after 3 days of daily fevers with the above associated symptoms,
No events; This spontaneous case was reported by a non-health professional and describes the occurrence of NO ADVERSE EVENT (No events) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergy to SULFA), Iodine allergy, Hypertension and Hypothyroidism. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) and AMLODIPINE BESILATE (NORVASC) for Blood pressure high, LEVOTHYROXINE for Thyroid disorder, CALCIUM and VITAMIN D NOS for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (No events). At the time of the report, NO ADVERSE EVENT (No events) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient has no problems with first dose.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Updated concurrent medical conditions which includes Drug allery(sulfa),iodine allergy,Hypertension and Hypothyroidism. Updated the vaccine information which includes the details of first and second dose. Added concomitant medications used. Updated the event details with the outcome of the events recovered/resolved. On 15-Jul-2021: Follow-up received on 15-JUL-2021 has No New Information
Affected my Menstrual cycle. Got my period 2 weeks early.; This is a spontaneous report from a non-contactable other healthcare professional.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9265) via intramuscular, administered in right arm, on an unspecified date, as 2nd dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. Historical vaccine included 1st dose of COVID-19 vaccine on unspecified date. The patient had no COVID prior vaccination and she was not tested for COVID post vaccination. The patient was not pregnant at the time of report. It was reported that the patient's menstrual cycle was affected on unspecified date and got her period 2 weeks early.   No follow-up attempts are possible. No further information is expected
Hives on legs above calfs, on thighs, lower abdomen, chest, back, neck, ears, head, shoulders, arms above elbows.
Pfizer-BioNTech COVID-19 Vaccine EUA Increased site redness, swelling and pain, site is  warm to the touch, also rapid heartbeat.
Redness / heat / swelling / soreness  left triceps injection site.  Started size of a quarter 06/09/2012 now soreness gone..heat and redness the size of a softball today.
40 minutes after tvaccines she was moving her leg a lot, not jerking. Like restless legs.  Said she could not stop moving them , but was walking fine  She said she felt something was pushing on her throat  No face swelling No cough, no rash, no emesis Breathing faster No retraction, no wheeze Complained of abdominal pain and abdomen was distended per mom   20 min after Benadryl feeling at throat and restless legs resolved Abdominal distension resolved by Am Good PO, no emesis or diarrhea
Case received form another manufacturer on Dec 22 2005 under the reference number WAES0511USA01987. It was initially reported by a health care professional that a 66 year old female patient received a dose of Fluzone no preservative 2005-2006, lot number U1825EA, intra muscularly in the left deltoid and a dose of Pneumovax 23, lot number 651318/1006P, intra muscularly in the right deltoid. The next day, the patient developed a fever of 102 degrees F. In addition, she had redness, swelling, pain and warmth of her right arm. She was seen by a physician on Nov 10 2005 and was diagnosed with Cellulitis of the right arm. It was noted that her right arm was red and raised and demarcated ion the leading margin. She had tenderness of the right upper arm. She was treated with telithromycin (Ketek) for nine days and Allegra D for 10 days. It was noted that the patient was unable to work and the reporter considered the events to be disabling and an other important medical event (OMIC). The events associated with the cellulitis were limited to the arm in which the Pneumovax 23 was administered. The patient has not recovered from the events.
after vaccination with fever; headache; body aches; This is a spontaneous report from contactable nurse. This nurse reported similar events for 6 patients. This is 3rd of 6 reports. A patient of an unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, headache and body aches on an unspecified date. Event took place after use of product. It was reported that "6 staff call in the day after vaccination with fever, headache and body aches".  The outcome of events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034195 Same reporter/drug/event/different patient
Was fussy after the shots, didn't sleep well that night, had temp of 102-103. Wed AM (4/6/05) temp was 105R, screaming, inconsolable, drove in car screamed. By the time they got to destination temp was 106R brought to ER. Given Advil, temp finally came down. Has had no lasting effects since then.
Patient showed signs of going into a catatonic shock acompanied by seizures, skin clammy and moist to touch. Blood Pressure dropped to 60/20, patient was in and out of this state for about 10 minutes. 911 was called and patient was taken to Emergency room.
Event occurred after 2nd dose. Patient was diagnosed with COVID 19 Remdisivir In-patient
pt recv vax & devel a hearing loss;MD reported the same exp w/another pt;no further details were provided;
pt recvd vax 16SEP95 & pt devel maculopapular, itchy rash consisting of 30-40 lesions all over the body, mostly on legs, abd & back;pt seen 2OCT95;MD noted that pustules were assoc w/40% of the lesions;dx eczema;also exp runny nose
Received routine first Hep A and MMR, with fourth PCV7, Hep B, IPV and DTaP immunizations at 1 year of age. Mom reported child exposed to another child who had cold like symptoms with fever, runny nose, and cough, etc week before and within 48 hours of 2/11/2009 vaccinations. Mom reported child okay all day experiencing soreness to bilateral thighs which she treated with age appropriate TYLENOL about 8 pm. By midnight mom advised child was "fussy" (cried, seemed to be in pain, no fever) so she retreated with TYLENOL. Approximately 5-630 AM on 2/12/2009 mom awoke with child "convulsing" describing her daughters eyes were starring ahead and her whole body jerking. Mom called 911 with grandmother placing child on side rubbing back. Mom currently remembers seizure lasted 10-15 minutes before rescue arrived with child sleepy and lethargic; however ER documentation document seizure at home lasted 3 minutes. While in the emergency department child has a second 2-3 minute seizure (treated with VERSED) with temperature of 102.2F (38.9C) (treated with TYLENOL and 2 hr later MOTRIN) with pulse of 133, respirations 36 and oxygen saturations of 97% room air. A sepsis workup including lumbar puncture was completed with admission to rule out meningitis.