chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A week after getting the booster I broke out in hives from my scalp to my feet that lasted a week. My skin became extremely sensitive to touch and would puff up. I was given a steroid shot and oral steroids for a week. My skin is still sensitive to this day so I take Claritin to help with the sensitivity.
One day post vax the pt awoke with inability to control movement in the right arm and leg for about 12 hours in the the arm and about 6 hours in the leg. Vision was also blurred in both eyes for about 12 hours.
left forearm extremely itchy starting the next morning, extreme itchiness last several days.  all over body itchiness for at least 4 days.  no reaction seen at site of injection.  no rash, although left forearm looked odd, perhaps inflamed and had two inflamed bumps, which may be moles (they ended up getting scratched and currently have scabs on them).
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 11-APR-2021 on left arm for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced symptoms which included headache, and body aches (suspected covid-19 infection). In early MAY-2022, the patient underwent Laboratory data included: COVID-19 rapid POC (Point-of-care) test which was positive which indicates suspected clinical vaccination failure. The patient was confirmed to be covid positive by second rapid test at doctor's office Laboratory data (dates unspecified) included: COVID-19 rapid POC test Positive. The patient was prescribed paxlovid by his doctor and his symptoms lasted for about 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000235807.; Sender's Comments: 20220630544-COVID-19 VACCINE AD26.COV2.S-Suspected Clinical vaccination failure- The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
After the Shingrix vaccine on 12/10/19 I felt so comfortable that I could not sleep that night.  I awoke the following morning, 12/11/19 with chills, exhausted and a fever that registered 101 degrees.  My chest between my breasts felt like it was being tightly squeezed.  This pain, that began intermittently, became constant and severe by the time I went to Urgent Care that night at 6 p.m.  My stomach was covered with a rash; large splotches of red that did not itch.
Heart rate shot up from 60 bpm to 111bpm tightening of chest with very pale complexion. Heart rate continued to fluctuate for the next hour from high to low, very lightheaded u able to walk.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no adverse evevnt; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.   This case is linked to cases 2023SA054981(CLUSTER) and 2023SA057733(CLUSTER).   This case involves child patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c (clesius) and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine, Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Warm, red raised area at site of injection. Denies itching, Area affected was approx. 3 x 5 inches.
This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M.A via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX on 19-MAY-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated.
I was diagnosed with vertigo 24Sep2021 thought to be related to inner ear inflamation.   I was treated with PRN Meclizine.
PATIENT RECEIVED VACCINE ON 4/4/21. ON 4/7/21, WAS AWAKENED DURING SLEEP WITH SHARP, STABBING PAIN IN LEFT LEG CALF MUSCLE. PAIN LASTED FOR 30-40 SECONDS. FOR THE NEXT 2 DAYS, PAIN IN THIS AREA REMAINED SORE, IRRITATED, AND TENDER. RATED PAIN 1-2/10 IF NOT TOUCHING THE AREA, BUT UP TO A 3/10 WITH TOUCHING THE AREA. IN ADDITION, FELT BREATHING HAS BEEN HEAVIER AND LITTLE WORSE THAN HIS NORMAL BASELINE (BASELINE DUE TO HISTORY OF ANEMIA/LOW IRON), AS WELL AS FEELING BRAIN FOGGY SINCE RECEIVING THE SHOT.
CHILD IS 10 YEARS OLD AND WAS GIVEN PFIZER ADULT DOSE
Reaction to 6/14/17 shots seen 6/15/17 and called pediatrician immediately. Red, swollen, inflamed and splotchy area around the injection site was noticed about 24 hours after the vaccinations. The thigh that received the MMR vaccine did not have a reaction, it was the thigh that received the Hib that showed the reaction. After 48 hours, the red, swollen, inflamed area had tripled in size and was the size of a large grapefruit. The reaction grew larger and faster than the reaction that was produced with the 03/08/17 vaccinations. The pediatrician was notified 6/15/17 and I was informed to give BENADRYL, MOTRIN and warm baths to work the leg out. The reaction started to subside about 4 to 5 days after the vaccines were given. They gave the shots in the opposite thigh that had the reaction to the 03/8/17 shots and Band-Aids were not used to rule that out. Was told to give BENADRYL, MOTRIN, baths and cream to prevent cellulitis or infection.
Sore arm; Little chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and CHILLS (Little chills) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and CHILLS (Little chills). On 12-Mar-2021, PAIN IN EXTREMITY (Sore arm) and CHILLS (Little chills) had resolved.            No concomitant medications were provided.  No treatment details were provided.
Pt.'s Neighbor states that after Pt. received the 2nd dose of Phizer 02/12/2021, started experiencing symptoms of immediate left arm pain continuing throughout the left side shoulder. No noted Primary visit. Can no longer lift or feel arm raised above the head.
Collapsed 15 minutes after vaccine, entire body broke out in a sweat (looked as if I got out of a pool), blood pressure rose to 280 / 140, turned pale, eyes dialted and chest pains. I was out for about 10 minutes and apparently was clutching my chest while being revived.
Breakthrough COVID case: Shortly after getting up I started coughing. It was a small but dry but noticeable cough. I used cough drops. I started to experience nasal congestion and feeling fatigue. It progressively got worse. Over the next couple of days. On 05/09/2022 I decided to take a rapid test which came out positive. I then went to a COVID test site and my results came back positive. I contact my doctor and was prescribed Paxlovid. It has helped. After 9 days I felt better.
severe increase in overall chronic pain systems.  Where my knees usually did not ache until I lay in bed (possible nerve compression) now it is throughout the entire day. Increasing as time goes on.  Can not say for sure it is from vaccine but not sure it isn't either.
After receiving the vaccine in the morning, patient developed eye swelling later on that evening, for which he took diphenhydramine 50 mg orally once. He felt better the next day, however the swelling came back the following day (12/24) in addition to eye itchiness. He was prescribed prednisone 60 mg orally daily for 5 days and diphenhydramine 50 mg q6h.
After Tdap given, employee experienced nausea, vomiting, dizziness, palpitations, pain @site. No swelling.
Administered #008C21A on conflicting dates. Date updated to 5/20/2021 in system. Vaccine was administered on 5/20/2021 but logged after 12:00am on 5/21/2021.
Stroke like symptoms.  Talking gibberish, no known words.  Staggering, then unable to walk.
Narrative: He reports having developed a rash after the initial vaccine. In brief: *He received the first vaccination in his left deltoid. *About 3 days afterwards, he noticed scatter erythematous pustules over his right forearm. These would errupt and then crust over. These were a/w mild occasional pruritus, but no pain or warmth. Once crusted, they have remained as hyperpigmented and non-blanching spots. *Since the concern began, these have spread to his right hand, then left upperarm and forearm. *He denies rash at any other locations. *No recent changes to detergents or environmental exposure(s). *He denies recent new rx or OTC medications or changes in dosing. *No contacts have a similar rash. *He has applied OTC low dose topical hydrocortisone to the rashes, which have minimally a/w the erythema and occasional itching. On examination - he has diffuse/scattered non-blanching/erythematous small areas of rash over b/l arms in various stages of healing. All lesions are crusted over at this time. All are non-tender to palpation.
This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 47-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) (batch number D7AE5, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv quebec ; (Flulaval Tetra) injection syringe for prophylaxis. Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE (FLU SHOT)). On 11th November 2021, the patient received FluLaval Tetra 2021-2022 season and Flulaval Tetra. On 11th November 2021, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The patient received Fluzone and Flulaval during the same season, which led to extra dose administered. The reporter consented to follow up.
Father reported today that his daughter still feels "sore" on the site where vaccine was given - RN asked if it is warm to touch, hard to feel and look red but father denies any of these - father mention he will observe few more days and call us back if it gets worse.
Next day 1/27/2021 fever of 101.3, chilling, and increased tinnitus, headache. Felt like I had a bad case of the flu. Actually felt worse than  when I had covid!!
Patient was in to pick up an Rx on 9/29/09.  He said that after he received his vaccine last week, he reacted to the pneumonia vaccine.  His arm was swollen, red and very painful.  He went to CDH ER and they diagnosed it as cellulitis from the vaccine and treated.  His arm is now fine.
fever; really bad chest pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable female (Patient) consumer or other non-health care professional of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration on 13Feb2021 single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. On 13Feb2021 23:00 the patient experienced fever and on an unspecified date of 2021 patient had really bad chest pain. The outcome of the event fever was unknown. The outcome of the event really bad chest pain was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 12JUN97 & exp loss of appetite, aching joints & h/a which resolved by 14JUN97;
I got feverish, 11PM. Then, I got Covid-19 12/29/2021. This lasted about 6 weeks.
Localized pain in the left arm. Rash that extends from injection size down to elbow. Rash is pink with a slightly red "crescent shaped" boarder on the outside of the arm. Swelling in the left arm (pt describes swelling to be about 1.5 times bigger than his right arm). Symptoms began yesterday evening and have continued this morning and are now slightly worse. He also complains that he is feeling "lousy". Doesn't think he has a fever. I have recommended that he apply a cool compress to the arm and alternate tylenol and ibuprofen for the swelling and pain. Pt suggested that he could take prednisone and I suggested that he should ask his doctor before doing that. Pt was worried that this is an infection, I assured him I do not believe that is what it is. I believe it is a common injection site reaction.
vasovagal syncopal reaction. I experienced sudden onset of feeling flushed and warmth body wide, sudden metallic taste in mouth, muffled hearing, dizziness, lightheaded, began to lose vision and consciousness, pallor noted by nurse caring for me, blood pressure recorded was 90/60. I have never experienced this type of reaction before to any vaccine or blood donation but know it can occur occasionally.
Nerve pain; lower back pain; Swollen lymph nodes; swollen and tender armpits; severe headaches, stiff neck
Patients received expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired vaccine). In October 2021, EXPIRED PRODUCT ADMINISTERED (Patients received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  Two vials where used 14 patients received the vaccine on 19-OCT-2021 and 8 patients received the vaccine on 22-OCT-2021,However the expiration date the vaccine expired on was 12-OCT-2021. She stated she had 112 doses ready to be dispose.
3;57PM PT STATES HIS BLOOD SUGAR IS DROPING - HE TOOK HIS REG DOSE OF INSULIN PLUS COVERED WITH ANOTHER 26 UNITS TODAY. BS 89 PER CONTINUOUS GLUCOSE MONITOR IMPLANT. A/O, PINK, W/D, RESP WITH EASE. STATES THIS IS 'LOW FOR HIM AND HE FEELS FUNNY'. JUICE X2 GIVEN. 4PM BS 87. GLUCOSE TABS X2 GIVEN. 4:10PM BS 83. WATER, FRUIT PACKS X2, HERSHEY KISSES X2 AND PEANUT BUTTER CRACKERS X6 GIVEN. 4:20PM BS 81. 3RD JUICE GIVEN.  PT REMAINS A/O , PINK, W/D, RESPONSIVE. 4:25PM BS 83. 4:28PM BS 85. PT STATES HE IS 'FEELING BETTER'.  4:31PM BS 87. 4:35PM PT STATES ' HE FEELS OK TO GO HOME AND WILL EAT A SUBSTANTIAL MEAL. HE HAS LOTS OF FOOD AT HOME'. JUICE AND PACK OF PEANUT BUTTER CRACKERS SENT HOME WITH PT. TO EXIT PER WHEEL CHAIR; CASE WORKER TO DRIVE PT HOME. NO ACUTE OR OBVIOUS DISTRESS. 4-8-21 11AM TC: PT STATES HE 'FEELS FINE NOW.'
Feverish, weakness, significant generalized myalgias, light-headedness. Probable fever X 1-2 days.
Erythema, swelling, warmth developed at site of injection and around arm.  Cellulitis developed and was treated by PCP.
Muscle aches, body aches, severe migraine, nausea, lost of sense of taste, extreme fatigue
Received MMRV vaccination at 1500. Dad states he had a quarter to half dollar sized knot / redness at injection site only with some itching that same evening. Dad gave Zyrtec then. The knot has decreased in size since onset (seen in office today, 1/14/16).
Headache, Myalgia, Arthralgia, NauseaVomiting, LEFT SHOULDER PAIN WITH TINGLING AND NUMBNESS RADIATING DOWN THE ARM INTO FINGERS Narrative:
Child sleeping in car seat - quickly went unconscious as his mother observed - taken to ER - had seizures x 2. Diagnosed with new onset epilepsy by Dr. Meds: Trileptal, Clonazepam; Diastat prn.   12/4/07 Reviewed hospital medical records which reveal patient experienced unresponsiveness.  Seen at outlying ER where clonic seizure activity was noted.  Transferred to higher level of care.  Tx w/antiseizure meds FINAL DX:cryptogenic complex partial seizure disorder stable on meds.
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: EWD185) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing); "PPM" (unspecified if ongoing); "AICD" (unspecified if ongoing); "Afib" (unspecified if ongoing); "coagulopathy" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN; PLAVIX; ECASA; COREG; ENTRESTO; ATORVASTATIN; WELLBUTRIN; METHIMAZOLE; HCTZ; OMEGA 3 [FISH OIL;VITAMIN E NOS]. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "recovering" and all described as "covid-19". The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Received Paxlovid 3 days after + COVID testing. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks: Anti viral details: start date=26Jul2022, stop date=30Jul2022, Indication=Treatment of COVID-19. Received Paxlovid 3 days after positive COVID testing. 3 days after completion of paxlovid went into refractory requiring 5 defibrillation attempts to convert to normal sinus rhythm. Ae treatment: Defibrillation x5, amiodorone drip & po.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202201026024 Same patient, different product and event;
12/28/04 local swelling and redness at injection site for 2 1/2 days.
EXTREME SWELLING OF BOTH ANKLES AND BOTH LEGS, PURPULISH PATCH NER TOES OR RIGHT LEG
Chest pain, shortness of breath, heart palpitations, heart rate way up and way down. For example 122 then down to 58. Happened twice in a 6 hour period.
Patient is currently in Pediatric ICU with diagnosed of Myopericarditis today 06/19/2021 Day #2 of hospitalization