chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left upper deltoid slightly warm to touch & mildly erythematous. Approx. 4cm X 3cm area. hard knot at injection site. No swelling, streaks numbness or tingling. No hives, trouble breathing or rest distress.
Fever; Myalgia; Nausea; Tiredness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Myalgia), NAUSEA (Nausea), FATIGUE (Tiredness) and CHILLS (Chills) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced PYREXIA (Fever), MYALGIA (Myalgia), NAUSEA (Nausea), FATIGUE (Tiredness) and CHILLS (Chills). On 21-Apr-2021, MYALGIA (Myalgia) outcome was unknown. At the time of the report, PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Tiredness) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter  Treatment included Tylenol   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: follow up included lot number from the second dose: 002C21A
Patient received his first dose of the Moderna Covid-19 vaccine as an expired vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received his first dose of the Moderna Covid-19 vaccine as an expired vaccine.) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received his first dose of the Moderna Covid-19 vaccine as an expired vaccine.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received his first dose of the Moderna Covid-19 vaccine as an expired vaccine.) 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.   no concomitant medications were reported. no treatment drugs were reported.
Swelling, erythema, fever to 102, leukocytosis (25,000), elevated LFT's.
Tested positive for the COVID-19 Virus after receiving his first COVID-19 Vaccine dose; Some congestion; Slight fever; This is a spontaneous report through the Pfizer-sponsored program. Two contactable consumers (one was patient's parent) reported that a 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm, with route of administration unspecified, on 24Feb2021 (15:30) as a single dose for COVID-19 immunization at the public health department (not a military facility). The patient's medical history was not reported. There were no concomitant medications. On 08Mar2021, after receiving the first dose of vaccination, the patient had tested positive for COVID-19 virus. The patient had a positive rapid COVID-19 Virus test on 08Mar2021, and was waiting for the results the COVID-19 virus PCR test. The patent was in quarantine. In Feb2021, the patient had some congestion and slight fever. The events were reported to be non-serious. The outcome of the events, 'tested positive for COVID-19 virus', 'some congestion' and 'slight fever', was recovering. The patient was scheduled for the second dose of vaccination on 17Mar2021, and would like to know if he should receive it.  Information about lot/batch number has been requested.
Dizziness & Palpitations Narrative:  Employee reported 3/1 to 3/7/2021 "mild/moderate palpitations, fast heart rate, light headed". Obtained medical attention "possible vaccination side effect; EKG done 3/5/2021; placed off work 3/1/-3/5, monitor". Resulted in 4 days  work missed.
This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 19-month-old male patient who received HAVRIX 1440 ADULT. On an unknown date, the patient received HAVRIX 1440 ADULT 1440 iu. On an unknown date, an unknown time after receiving HAVRIX 1440 ADULT, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown. Additional information: A 19 month old was inadvertently administered HAVRIX 1440.
Mom phoned and stated that on the 4th day after child received Hep A #2, left upper arm swollen up, golf-ball size with a lump on it at the injection site, hot to touch, itching, slight fever. Mom took her to the ER (because it's 9 PM). ER MD told mom to give her Tylenol and Benadryl if it still itch. Mom gave child dose of Tylenol.
Upon disease investigation of 8/20/21 case reported onset of symptoms as 8/14/21 which included fever, subjective fever, chills, rigors, muscle aches, runny nose,  sore throat, new olfactory disorders, headache, fatigue, cough, wheezing, shortness of breath, chest pain, nausea, abdominal pain, diarrhea, loss of appetite and ear pain.
pt fell asleep on the way home, & slept approx 3 hrs awoke around 11230 was crying as if hurting & was inconsolable-mom noticed stiffness of limbs & then started shaking; t101; runny nose;
Patient had Moderna booster on 12/6, started  Saturday  with back of right leg muscle pain and now on side has a bump. The size of half dollar and is slight red and tender to touch. Thinks the right leg is swollen but unsure.  Positive for DVT within the right popliteal and posterior tibial veins.
administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK 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 medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223559:same reporter
Epigastric pain, fever, malaise -> started w/in hrs of receiving vaccine. Improving slowly but persistent to day 5.
On 8/16/21 at approximately 4:00pm an 8 yrs old child was given a Pediarix (Dtap-HepB-IPV) vaccination mistakenly, when the child was not due for any immunizations.  The child did not have any adverse reactions and no medical treatment was needed.
01/19/2021  developed chest pain, shortness of breath and fever 100.8.  Went to ER and was diagnosed with acute pericarditis
pt recv vax & devel an inj site rxn characterized by redness, swelling & pain;pt also exp knots & elevated temp around inj site;sx lasted for @ least 1wk;this is one of six pt from this site to report adverse rxn;
This 77 year old male received the Covid shot on  1/27/21    and went to the ED on 2/1/21     and was admitted  on 2/2/21 with the following diagnoses listed below. SIRS (systemic inflammatory response syndrome) Pneumonia, unspecified organism Acute kidney failure, unspecified
Reoccurring numbness in the right arm throughout the day. At night both  hands may experience numbness. Right foot occasionally goes numb while walking. Numbness is relived by flexing hands, arms, and feet. No treatment sought. This is still an ongoing issue.
Patient on 4/1/2021 experienced bruising, mouth blisters and heavy menstrual bleeding;   4/2/2021 saw her PCP; PCP advised patient to present to the ED. Patient was admitted 4/2/2021 and discharged 4/3/2021  upon admission patient plts were 3000; received plt infusion and started on IVIG
Patient is a 81 y.o. male who presented from  assisted living  on 9/22/2023 with lightheadedness and dizziness and falling twice. Had been coughing several days, tested positive for COVID in the ER. During admission, ID and Cardiology evaluated. ID recommended remdesivir 5 days and Decadron daily until discharge. Cardiology recommended pushing Mitraclip procedure to 21 days after isolation. He tolerated COVID therapy without issue and returned to room air. Medically stable for discharge to his facility and to follow-up with already established PT as outpatient.   Falls Reduced Mobility, POA -Patient states he has been falling over the last 8 to 9 months however he fell twice on day of hospitalization.  recently moved into assisted living, and review of his outpatient records it also appears he is in the process of obtaining an electric wheelchair/scooter -continue PT as outpatient; does have his own DME equipment    COVID-19  Acute Hypoxemic respiratory failure, resolved - Symptom onset: suspected ~ 9/19 - Positive COVID-19: 9/22 at health clinic - Vaccination status: Vaccinated with Pfizer with last dose 12/14/22 - Decadron: Yes. Expected end date today - Remdesivir: Remdesivir completed 5 day course today -Stop decadron upon discharge; ensure COVID vaccination in near future; no home oxygen needs   HFrecEF -Ischemic Cardiomyopathy; Grade C, Class I; Follows with heart failure clinic; Home regimen includes Entresto 49-51 mg twice daily, Toprol 50 mg daily, eplerenone 50 mg daily, Farxiga 10 mg daily(held Farxiga during admission) -TTE 5/2023 45+/- 5%.  -continue Entresto, Toprol, eplerenone, and farxiga on discharge; resume Lasix 30mg PO on discharge; management of valvular pathology as below; weight at discharge 206lb   Severe mitral valve regurgitation Moderate aortic valve regurgitation -Followed by structural heart -Patient scheduled to undergo MitraClip on 9/28/2023 -Structural heart to call and reschedule Mitraclip procedure upon discharge, recommending 21 days after isolation ends (Last day isolation would be 9/28/23)    CKD stage IIIa History of renal transplant -His renal function appears to be at baseline with GFR near 50 -We will continue his anti-rejection medications and TMP-SMX for PCP prophylaxis and discharge; check BMP in one week   Diabetes mellitus type 2 -Hemoglobin A1c 5.1% on 2/24/2023 -Home regimen includes Tresiba 30 units under the skin every evening; patient also on Farxiga given his CHF -Resume home regimen on discharge   CAD -Continue aspirin and atorvastatin History of Reiter's syndrome History of rheumatoid arthritis -Patient with arthritis of all toes, cannot move toes   BPH -Continue Flomax   Anxiety -Resume home PRNs on discharge
pt recv vax; devel swelling of lt upper arm from shoulder to inferior portion of deltoid;pt returned to clinic, area firm, tender to touch & warm;c/o fever & chills also;instructed to use apap & compresses to area;T not taken;
Pt states her arm is still sore to the touch 14 days after vaccine-no redress or fever. I advised her to have her doc take a look at it and assess for infection.
High heart rate - 125 beats per minute; Body/muscle aches; Fever - 101 degrees; Nausea; Headache.
Near syncopal episode within 24 hours of booster injection with Moderna. Intermittent lightheadedness and marked fatigue ever since.
Had all the vaccines and boosters except for the newest one/completed Paxlovid for Covid-19 infection; Had all the vaccines and boosters except for the newest one/completed Paxlovid for Covid-19 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. 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 Sep2022, outcome "recovered" and all described as "Had all the vaccines and boosters except for the newest one/completed Paxlovid for Covid-19 infection". The patient underwent the following laboratory tests and procedures: Body temperature: (Sep2022) 102.9 Fahrenheit; SARS-CoV-2 test: (Sep2022) Positive; (Sep2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller states he completed Paxlovid for Covid-19 infection. Caller states he had all the vaccines and boosters except for the newest one. Caller states he was waiting until he fully recovered from Covid-19 to get the new booster. Caller states when he had Covid-19 he experienced 102.9 F (Fahrenheit) fever. Caller states, "It felt like an truck parked on my chest." Caller states he took Paxlovid and tested positive for at least 3 or 4 days before he tested negative. Caller states he feels like Paxlovid helped keep him out of the hospital.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
1st dose in 2019, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comments: The patient born 1948 took first dose in 2019 and never got second dose. Chat disconnected before HCP provided details. During this interaction with HCP by chat, there was no opportunity to ask for permission to follow up since the HCP disconnected the chat immediately after getting medical information response. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Prevnar was administered to patient between 12:30-1pm and said she'd experienced arm pain, redness, and fever. She'd been taking otc pain meds and applied ice patches to the area. Patient came to the pharmacy on 2/15 in the morning (approximately 5 days after administration) complaining of arm pain and the development of localized hives around her upper arm. She's attempting to book an appointment with the doctor.
Sore arm for 5 days, warm to touch, 3x3 in rash
The pt developed dyspnea and wheezing, 10 minutes, post vax. She received IV epinephrine in the ambulance. 25 minutes later, symptoms of airway tightening ceased. No further treatment required. Did not have her inhaler prescription with her.  Follow up 10/07/2002: "It was reported that patient developed dyspnea and wheezing 10 minute post vaccination.  Vital signs were stable.  Patient received Epinephrine IV in the ambulance.  Symptoms of airway tightening ceased 25 minutes later.  No further treatments required.  Patient didn't have her inhaler with her at the time.  Seriousness Criteria: Medically Significant."
Pain on left arm from shoulder to fingertips. Three inches in diameter red, itchy, and painful rash on left shoulder were vaccine was injected.  Felt very fatigued and feverish for Two days after shot.
Arthralgia, Fever, NauseaVomiting, fatigue Narrative:
OFF-LABEL USE; RECEIVED 0.3 ML OF THE JANSSEN COVID-19 VACCINE INSTEAD OF 0.5 ML; RECEIVED 0.3 ML OF JANSSEN COVID-19 VACCINE TODAY INSTEAD OF SECOND DOSE OF PFIZER COVID-19 VACCINE; This spontaneous report received from a health care professional concerned a 21 year old female. 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 not reported, batch number: 30130BA and expiry: 30-NOV-2021) .3 ml, administered on 21-SEP-2021 for prophylactic vaccination. Concomitant medications included BNT 162 for prophylactic vaccination.  On 21-SEP-2021, the patient experienced off-label use. On 21-SEP-2021, the patient experienced received 0.3 ml of the janssen covid-19 vaccine instead of 0.5 ml. On 21-SEP-2021, the patient experienced received 0.3 ml of janssen covid-19 vaccine today instead of second dose of pfizer covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off-label use, received 0.3 ml of janssen covid-19 vaccine today instead of second dose of pfizer covid-19 vaccine and received 0.3 ml of the janssen covid-19 vaccine instead of 0.5 ml was not reported. This report was non-serious.
Swelling of eye lids and under eyes, swelling of lips and tongue, hives on chest, neck, face, and upper back, inside and on the back of legs, a little bit of wheezing, swolen knot at injection sight.
Redness & itching to left upper extremity; treated with bacitracin & diphenhydramine.
Narrative:  94yo patient who does not receive medical care from agency, died on 9/24/2021. No information rearding pt's death available. Pt had hx of dementia, chronic afib and history of cva. Pt did receive covid vaccines on 4/7/21 & 5/15/21. Likely this death is not related to covid vaccines given patient's advanced age, comorbidities, and long length of time between date of vaccines and date of death.
Patient is a 83 y.o. male with a history of severe chronic systolic CHF (EF 6%), COPD and recent admission from 11/1/2022 through 11/4/2022 for pneumonia who presented to Hospital1/2/2023 with worsening shortness of breath. COVID-19 positive and acute on chronic CHF. Pt and family met with palliative - code status changed to DNR CC and discharged home with hospice   1. Acute on chronic systolic CHF: EF a year ago 12/2021 with EF 21%, now down with TTE 11/20/2022 with EF of 6%, persistent moderate to severe MR despite MitraClip. NT proBNP 29,200 on admit.  Chest x-ray on admit interstitial opacities. Progressive dyspnea and overall decline since last admission and likely due to heart failure and MR, seems pt unable to tolerate full GDMT. improved with IV lasix, transitioned to home oral (will schedule on discharge, was on prn). Palliative met with pt and family, agreed to hospice 2. COVID 19: positive on admit.  Mild hypoxia on admit and started on oxygen, now weaned off. Given dexamethasone in the ED, changed to oral x 10 days total 3. DM type 2: Last A1c 8.6, now 9.0 on admit. Held Jardiance and metformin on admit. On low dose Lantus at home. Sugars uncontrolled due to IV Decadron and increased insulin regimen - IV changed to oral and sugars improved, stopped prandial and decreased Lantus 4. COPD: by hx. Does not have rescue inhaler, only Advair - ordered prn Albuterol 5. Moderate to severe MR: per echo 11/2022 despite Mitraclip x 2. 6. Dysphagia: Per history.  Recommended ground meats and thin liquids   Pt doing the same, no new complaints. Went over med list in detail with daughter in law. I spoke with palliative and hospice services, everything set up for discharge home with hospice   Changed Lasix from prn to every other day and hold if SBP less than 90; Lantus to decrease once Decadron completed. Discussed with daughter
On Friday, November 12, 2021 client PT came to vaccination for a Covid-19 Pfizer booster dose. Client received his first dose of Astrazeneca on July 7, 2021. During assessment questions, client denied any allergic reaction to previous vaccines and no chronic medical history. Astrazeneca is a WHO approved vaccine. Submitted medical consult via text to Vaccine Operations Lead who confirmed for client to receive Pfizer booster dose with 30 minute observation. Client received his Covid-19 Pfizer (LOT #: FF8839) at approximately 12:24 PM in his left arm. Client experienced no adverse reaction while waiting in Observation Area and left vaccination site with a steady gait at approximately 1:00 PM.
produced tingling and numbness on the left side of the jaw and arm; produced tingling and numbness on the left side of the jaw and arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (163738).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Sep2021 (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: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "produced tingling and numbness on the left side of the jaw and arm".  Additional information: It was reported that , I am a pharmacist that administered a first dose of Pfizer Covid vaccine 21 days ago to a patient and it produced tingling and numbness on the left side of the jaw and arm. It last approximately 24 hours . Patient has no history of Bell's Palsey or any type of facial paralysis. Can you provide guidance on it to administer the 2nd dose or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.