chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Error in injection of vaccine. Injected only the diluent (step 1) of the SHINGRIX vaccine, without reconstituting the vaccine first. Patient did not have any immediate effects. Waited 10 minutes to monitor patient. Proceeded to give the patient the correct dose/reconstituted vacccine after giving only the diluent. Monitored patient for 10 minutes. Informed patient of what had happened.  Patient was okay and did not display any signs or symptoms of any kind of reaction to either of the injections.
patient was 17 years old at time of administration; Moderna is not approved for administration to this population; no adverse outcome
Dizziness, lightheadedness, diaphoresis, rapid shallow breathing 5 minutes post vaccine, Ice packs applied to posterior neck and forehead prior to vaccine (pt stated she always gets this way with vaccines/finger pokes, etc).  Client lowered to yoga mat, legs elevated, water and cookies offered, but client refused at this time.  Vital signs stable 5 min post vaccine and 20/25 minutes post vaccine.  Client able to move to sitting position, transfer to chair, stating she feels much better, denies dizziness, lightheadedness, diaphoresis, breathing returned to normal rhythm.  She was able to ambulate around setting without incident.
Patient received dose of a vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No medical history.     On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-122634, US-MODERNATX, INC.-MOD-2021-122456, MOD21-089636, MOD21-089642, MOD21-089644, MOD21-089646, MOD21-089650, MOD21-089655, US-MODERNATX, INC.-MOD-2021-123137 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-122634: US-MODERNATX, INC.-MOD-2021-122456: MOD21-089636: MOD21-089642: MOD21-089644: MOD21-089646: MOD21-089650: MOD21-089655: US-MODERNATX, INC.-MOD-2021-123137:crosslinked
Moderna  COVID-19 Vaccine EUA.....  Symptoms began at 5am on the morning of 3/17, swelling of the tongue and lymph nodes, also sweeling on  left side of face by the ear and jaw.  Headache, elevated heart rate, weakness
eye swelling, fatigue, dizziness, clumsy, nasal congestion, loss of taste,  abdominal pain.
Developed symptoms of fever, Headache and body/joint aches, evening of 10/26/21. Tested on 10/27/21 brand name Covid-19 with results Positive.
Patient's family reported acute confusion day after vaccinations. Patient's wife called doctor's office and was recommended to go to ED. Patient was admitted due to sepsis from ED. Later when recounting what has occurred at hospital, patient's wife reported that left arm was red and swollen three days after immunization was given. Hospitalist treating patient have not identified what the infectious source is for this patient.
Patient felt warm, flushing from waist to feet; BP, pulse, respiratory rate, and O2 sat: 132/69, 78, 20, 99%. Felt better after 15 minutes.
Pt called for Dose 2 appointment. Contracted COVID right after Dose 1 Moderna Vaccine. Hospitalized 2/08/2021. Discharged 2/10/2021.  Admitted with nausea, diarrhea, lightheadedness, and weakness. Pt treated for Covid-19 Infection with GI symptoms, Acute Kidney Injury, Leukocytosis
This case was reported by a consumer and described the occurrence of flu like symptoms in a 39 year old male pt who received hep B vaccine (unk manf). A physician or other health care professional has not verified this report. On 22Jun02, the pt received the fourth or fifth dose of hep B vaccine. At an unspecified time following the admin of hep B vaccine, on 22Jun02, the pt experienced flu-like symptoms, malaise, and nausea. The pt stated that following the admin of hep B vaccine, he was out of work the afternoon of 22Jun2002. On an unspecified date, the events resolved.
In  vaccination clinic, patient presented for two vaccination, Fluzone-HD and Covid-19 booster, shots. While in preparation to give the vaccinations, I had patient to repeat what vaccines he was going to received that day. He said that he wanted the Flu and Covid-19 booster. Then, I processed to vaccinate. When processing, I saw that he had previously received this shots.
Post vaccination I didn?t feel well right away. At 3 minute marker I became dystonic, dizzy, faint, pressure of chest, weak, heavy breathing, throat felt tight, felt very hot, heaviness of body-felt like I couldn?t move. I felt frozen. Vitals were taken: high blood pressure and pulse rate; I refused Epi because I knew it wasn?t anaphylaxis based on my vitals and the fact that it wasn?t that my throat was closing but it felt ?tight?. This lasted about an hour. Then I had ?episodes? of these same symptoms with a couple minutes in between for 6 hours. My body was weak, I was faint/dizzy, sensitive to light, beyond exhausted (slept for days), chest tightness fever of 101-102.3 for 4 days. Symptoms like this and random fainting spells lasted for 3 weeks. I went to the emergency department and they didn?t listen to me that it was because of the vaccine. I got the second dose because I was forced to in order to continue my nursing program?: I was scared and anxious that I was forced to get the second dose. It has now been about 10 months. Post both shots I still got COVID and had intense migraine headache, sensitive to light, very weak/faint, fever got up to 102 for 3 days. Post all this every day I deal with random dizzy spells and thudding of my ear along with being extra sensitive to what I eat and drink.
Received MMR and Comvax on 9/14/00. On 9/23 and 9/24, went to ER with symptoms of seizure activity. Referred to an MD; who reported the seizure was R/T MMR.
Employee of FCHD reported at time of injection on 10/28/10 of the influenza vaccine, she experienced excruciating pain in her left shoulder. Vaccination was provided at an Employee Health Vaccination Clinic. She continues to report pain at a "6-7" today on the pain scale. She has not sought medical care & is taking ADVIL for pain.
Two days later I tested positive for Covid after cold like symptoms appeared/Sore throat, runny nose, and chills; Two days later I tested positive for Covid after cold like symptoms appeared/Sore throat, runny nose, and chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, brand: Pfizer), on 22Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 16Mar2021 as dose 2, single (Lot number: EN6203), in right arm and on 14Dec2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 56 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "moderate high blood pressure" (unspecified if ongoing). Concomitant medication(s) (Other medications in two weeks) included: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE. No Covid prior vaccination. No Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jun2022 at 17:00, outcome "not recovered" and all described as "Two days later I tested positive for Covid after cold like symptoms appeared/Sore throat, runny nose, and chills". Clinical course as follows: Sore throat, runny nose, and chills after being exposed to her husband who tested positive for Covid. Two days later she tested positive for Covid after cold like symptoms appeared. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive, notes: Two days later I tested positive for Covid after cold like symptoms appeared; (22Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Co-vid arm Treated with ice- no further swelling 2 days later, still itches
10/6/17 - mild headache/migraine and fatigue. 10/7/17 - dizziness and blurred vision.
FELT BAD; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included rivaroxaban. On an unspecified date, the subject experienced felt bad. The action taken with covid-19 vaccine  was not applicable. The outcome of felt bad was not reported. This report was non-serious.
Patient was vaccinated on 12/10/15 with the vaccines Tdap, Pneumonia, and Influenza. That same day patient started to feel malaise on the arms but the next day after 12:00pm felt high fever and the right arm started to show an edema - there was an abscess under the right arm. On the third day after vaccination patient felt weak and started to vomit and got dehydrated. Patient went to the hospital and was given BENADRYL for the arm swelling and got fluids intravenously.
This spontaneous case, initially received on 23-Sep-2016, was reported by a health professional and concerns a 49-year-old male patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 23-SEP-2016 to 23-SEP-2016. Dose: 0.5 ml single dose, Route of administration: Intramuscular. Batch number WT54707. No additional suspect drugs. Adverse reactions/events and outcomes: On 23-Sep-2016, the patient experienced small wet spot on (skin) site from leur lok, not from injection site (outcome: recovered / resolved). The patient had no adverse effect from vaccine on skin at site (outcome: recovered / resolved). Reporter comment: The healthcare professional considered the events as non-serious and reported the classification: quality defect. Follow-up received 21-Oct-2016: The patient had no concomitant medications. The patient has not previously received AFLURIA. Indication for use was approved as per the Product Information Leaflet. The product was not stored correctly. Action taken with drug: None, dose was administered and empty syringe was discarded into sharps container. On 20-Sep-2016 (also reported as 23-Sep-2016), the patient may not have received full dose (outcome: recovered / resolved, special circumstances: underdose) as luer lock may be defective at connection causing fluid to leak. The patient does not report any adverse reactions. No treatment needed. Cleaned fluid and area where fluid leaked. Reporter comments: The healthcare professional considered the event unassessable. The as reported term 'Small wet spot on (skin) site from leur lok, not from injection site' changed to 'Small wet spot on (skin) site from leuk lok, not from injection site / Patient may not get full dose - no adverse effect' (special circumstances: exposure via skin contact without adverse event, underdose without adverse event) and coded to preferred term: no adverse event. Additional information received on 24-Jan-2017: QA investigation results: Final assessment: Risk has been excluded. The review and investigation of the manufacturing, dispensing, shipping and product testing of Influenza Vaccine lot: WT54707 found no evidence of a product quality issue to prompt the potential 'vaccine reaction'.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022 at 7:01 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Feb-2022 at 7:01 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was not reported. .
The 5-11 vial (10mcg/mL) was diluted 2ith 2.2 mL sodium chloride and given to 3 year old patient. Guardian of patient was notified. Patient is not experiencing side effects at this time.
Pt received-Hep A pediatric; IPV; Meningococcal 4; TDAP and Varicella-had vasovagal reaction fell out of chair to floor. Went to ER examined-sent home-no break in skin.
The arm pain was right away and has not gone away after a couple days. A headache a d sweating started around 9 Pm, 5 hours after the shot. I woke up at 7 Am the next morning unable to stay warm, shivering for hours with a 101 fever and nausea that lasted most of the day.
Around 10pm that evening patient started having the chills, muscle aches, fever, face became flushed and hot, hives developed at the injection sites that then spread down his arm and he also reported experiencing slight delirium. He stated these symptoms lasted until Saturday 11/4/17 am at which point only he was only experiencing the muscle aches, but still had a large red and tender rash that covered most of his left upper arm. On Sunday, 11/5/17, he stated that his left arm was still sore and the rash was still present but shrinking. Upon examination today, 11/6/17, the rash measured 11cm in width x 32cm in length and was tender to palpitation. His temperature was 98.0 degrees F.and he is still experiencing some soreness in the left arm as well.
Nurse shot the vaccine needle into the side of my head by accident - Then I took another shot in my arm. Not feeling the greastest as I also have AFib heart and will consult w my Primary Care Doc
cold symptoms  running nose, fatigue onset a few days after vaccine getting increasingly worse, including moderate congestion, cough and difficulty sleeping
Pt came to visit with 3 year old sibling. 4 month old was given FLULAVAL vaccine by new medical assistant by error instead of 3 yo sibling. Followed with mother today pt has subjective fever, mom gave tylenol. Otherwise doing fine.
Headache, insomnia, severe discomfort at injection site (swelling, itching, redness and tenderness) - little to no improvement in 6 days since vaccination
pt recv vax 22SEP97 1130AM & 6:30 pt started jerking-an apparent sz-mom took pt to ER about 7PM;pt seen by MD 24SEP97 & was fine;pt was lethargic x2 days-OK now;
tested positive for COVID-19 (C19); tested positive for COVID-19 (C19); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administration date Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Jan2022, outcome "unknown" and all described as "tested positive for COVID-19 (C19)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Jan2022) positive. Clinical course: The patient received initial 2 doses of COVID-19 vaccine last year (in 2021) and this fall was boosted. On Monday of this week, the patient tested positive for COVID-19 (C19). And today, 5 days later, the patient is not dead and was not hospitalized. The patient did not need a ventilator. The case could easily be described as mild.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Left axililla cellulitis abscess,, fever, soft >4cm hematoma in area of left axillia lymph node presenting 24 hours post vaccine administration
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SEVERE CHILLS; BONE AND JOINT PAIN; FEVER; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 50 year old white female of unknown ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, alcohol use once every 3 months, and non-smoker, and other pre-existing medical conditions included: the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy (mild hives) when treated with omeprazole, and azithromycin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, frequency one total administered on right arm on 10-APR-2021 at about 10:30 for prophylactic vaccination. No concomitant medications were reported.  On the day of vaccination after 6 to 8 hours of taking vaccine, the patient experienced severe chills, fever for 12 hours, nausea and fatigue for 4 days, bone and joint pain relieved after 24 hours. On 13-AUG-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: IgG (Immunoglobulin G), Spike protein, semi-quantitative Antibody test (NR: not provided) Negative. On an unspecified date the patient took Tylenol and Advil for fever.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe chills, bone and joint pain, and fever on 11-APR-2021, and nausea, and fatigue on 14-APR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189749.; Sender's Comments: V0:20210832418- covid-19 vaccine ad26.cov2.s -CONFIRMED IMMUNOLOGICAL VACCINE FAILURE . This event(s) is considered not related. 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
immobility; irreversible kidney damage; Mild foor eyelid swelling; low albumin; +360 cholesterol; Foamy urine; HBP; impaired cognition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 02May2021 at 11:00 as dose 1, single (Lot number: EW0167) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (ongoing). Concomitant medication(s) included: ADDERALL oral taken for attention deficit hyperactivity disorder (ongoing).  The following information was reported: IMMOBILE (medically significant), outcome "unknown", described as "immobility"; RENAL INJURY (medically significant), outcome "unknown", described as "irreversible kidney damage"; SWELLING OF EYELID (non-serious), outcome "unknown", described as "Mild foor eyelid swelling"; BLOOD ALBUMIN DECREASED (non-serious), outcome "unknown", described as "low albumin"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "+360 cholesterol"; URINE ABNORMALITY (non-serious), outcome "unknown", described as "Foamy urine"; HYPERTENSION (non-serious), outcome "unknown", described as "HBP"; COGNITIVE DISORDER (non-serious), outcome "unknown", described as "impaired cognition". The patient underwent the following laboratory tests and procedures: Blood albumin: low; Blood cholesterol: high, notes: +360 cholesterol; Blood pressure measurement: High, notes: HBP; Blood test: low albumin, low vitamin D, High cholesterol; Oedema: +20 lbs, notes: swelling progress to +20 lbs of edema; Urine analysis: loss of protein; Vitamin D: low. Therapeutic measures were taken as a result of immobile, renal injury, swelling of eyelid, blood albumin decreased, blood cholesterol increased, urine abnormality, hypertension, cognitive disorder.  Clinical course: Patient received second dose on 23May2021 at 11 AM on Left Arm (Batch/Lot Number: EW0185). Mild foor and eyelid swelling progress to more than 20 lbs of edema, low albumin, more than 360 cholesterol, foamy urine, HBP, immobility. Impaired cognition, irreversible kidney damage. Biopsy performed stated minimal change disease. She have never had any issues ever. Now on medication and dealing with this for life. The patient did not have any prior vaccinations within 4 weeks. Th patient's family history did not have any medical history relevant to the adverse events.
Booster; Violent chills; Puking; Massive headache; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 31 year-old male patient received bnt162b2 (BNT162B2), administration date 09Dec2021 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot unknown: True, prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, prev dose dose number: 2), for COVID-19 immunization; Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot unknown: True, prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, prev dose dose number: 1), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; CHILLS (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Violent chills"; VOMITING (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Puking"; HEADACHE (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Massive headache"; FATIGUE (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Fatigue". Therapeutic measures were not taken as a result of chills, vomiting, headache, fatigue.  Additional information: Unknown If any other vaccine was taken in four weeks. Unknown if  the patient tested positive for Covid prior vaccination. Unknown if  the patient tested positive for Covid post vaccination:   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt developed fever of 102 04/18/04.  On 04/19/04 found unresponsive with foaming of mouth and perioral cyanosis.  Paramedics called.   On their annual crying.  Our arrival to ER, vital signs normal.