chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer (subsequently medically confirmed), describes the occurrence of exacerbated asthma, cough (really bad chronic cough), dyspnea (hard to breath), illness (sick) and pain (hurting so bad) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 002D21A) for COVID-19 immunization. The occurrence of additional events detailed below. Concurrent medical conditions included asthma. On Mar 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 23, 2021, patient experienced exacerbated asthma, cough (really bad chronic cough), dyspnea (hard to breath), illness (sick), pain (hurting so bad) and pharyngeal swelling (lump under throat that was swollen). At the time of the report, exacerbated asthma), cough (really bad chronic cough), dyspnea (hard to breath), illness (sick), pain (hurting so bad) and pharyngeal swelling (lump under throat that was swollen) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications reported. Treatment included nebulizer every 3 hours and OTC cough medicine.
Patient was given an undiluted dose of Pfizer vaccine. The vaccine was not reconstituted prior to administration.
This spontaneous report has received from a medical assistant via a field representative refers to a 38 years old female patient with unspecified heart condition who was also a nurse working in the office. Information about drug reactions/allergies, concomitant medication and medical history was not provided. In approximately 2018 (reported as recent past), the patient received a dose of PNEUMOVAX 23 (Lot# R016638, expiration date 02-JAN-2020; strength, dose, frequency were not reported) intramuscularly in the arm for prophylaxis. On an unknown date of 2018, the patient experienced welts, redness, fever, pain at injection site; all symptoms worsened over time, so the patient saw nurse practitioner in the office. The patient was treated (unspecified) and out of work 2 days with earlier specified symptoms including difficulty lifting arm. The patient was considered recovered at the time of reported. Per medical assistant, there were no reports of PNEUMOVAX 23 undergoing any temperature excursion. The causality assessment was not provided. The events were considered to be significant disability or incapacity by the medical assistant. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1810USA011628.
Initial information received on 28-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age patient who experienced due to temp excursion product was not acceptable for use, while he/she received vaccine ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect HIB (PRP/T) Vaccine lot number not reported. It was case of medication error due to product storage error. 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 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.
Missed 2nd dose of Moderna vaccine before 36 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine before 36 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine before 36 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine before 36 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
From initial information received on 11/01/2004 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 61 year old female patient received a TD ADS Adult vaccination, lot number U1354AA, administered in the left deltoid on 10/20/2004.  The route of administration was not reported.  9 days later, on 10/29/2004, the patient developed a local reaction of redness, which measured 2 inches around the injection site.  The patient was seen by a physician, who prescribed a Medrol pack.  Per the reporter, the patient's recovery status is unknown.
This spontaneous report as received from a physician refers to a Pharmacy technician 50 years old female patient. On May 2012, the patient was vaccinated subcutaneously with, 0.65 ml ZOSTAVAX (dose and lot # not reported). No concomitant medications were reported. The physician stated that on May 2012, a pharmacy technician developed an injection site reaction and general feeling of malaise that (within a few days of the vaccination) kept her from work for close to a week after received ZOSTAVAX. No laboratory test was performed. The patient sought unspecified medical attention. At the time of the report, the patient recovered from the events (approximately in 2012). Additional information has been requested.
9 days after receiving the booster on Nov 17th overnight, broke out in hives, extreme itching.  Started in head, but also moving to torso, waistline, groin.  Also had a tight feeling in esophagus like a swallowed a pill, which coincided with MINOR swelling of tongue. These symptoms continued badly for 4 days all over body in random spots coming and going, plus chest tightness coming and going always with tongue sides swollen slightly. Nov 20 doctor gave a steroid shot and prednisolone 5 day pack of pills which helped a lot, but symptoms have continued still. Today is 4 weeks since the initial hives outbreak.  Since the steroid shot/pills, the symptoms now are not big hives, maybe just minor, but itching red bumps, itching and scratching red inflamed lines, all different body parts, comes and goes, some days better than others.  Taking Zyrtec most days. Benadryl some nights. Hydrocortisone cream if it itches a lot.  Seems like I am keeping the bumps and itches from turning in to the huge welts and hives by staying on antihistamine and cream. If I have a mild day and go off for a day, the next day it is back.  Just read on this case of dozens of others with same delayed symptoms after booster:  https://www.cureus.com/articles/69363-chronic-spontaneous-urticaria-after-covid-19-vaccine?open_comments=true#article-comments-section
09/22/21 PT brought to er via EMS from nursing home unresponsive; wbc 16.0, bun78, creatinine 4.0, ast 482, alt 289 lactic acid 6.0, COVID positive; pt dnr dni with limited interventions, bp 79/40 after receiving 2 L of normal saline assessment: septic shock, secondary to COVID pneumonia; acute chronic renal failure, chronic kidney disease state IIB
swollen lymph node in armpit (right) (painful, red, has been there for 72 hours and is not abating) pain/redness/rash at injection site
On 4/20/203, we were notified by upper management that the Pfizer monovalent vaccine was no longer authorized for use AND that the authorization actually ended the day PRIOR to the patient's vaccine being administered.  The patient experienced NO NEGATIVE ADVERSE EVENTS as a result of the vaccine being administered.
Patient presented to office on 8/4/21 with complaint of feeling tender along rt scalp/head with tender rt neck glands and a feeling of pressure in rt ear. On exam, she had small, tender mobile post auricular and occipital lymphadenopathy.  Patient returned to office 8/9/21 with tender, eryth, vesicular eruption along rt forehead/upper rt eyelid dermatomal region consistent with shingles. She was treated with antiviral
Patient received one flu shot on 8/12/22 at a different Pharmacy, she received  a second flu shot of the same series/year on 10/3/2022. She has had no reactions to our knowledge at this point.
Swollen lymph node, soreness and tender in that area. Headache and brain fog, and pain in jaw and sinus area.
Little sore arm; Felt tired; Was given 3rd dose of Moderna covid-19 vaccine accidentally instead of Shingrix vaccine; accidentally administered Moderna covid-19 vaccine as third dose instead of shingrix vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Little sore arm), FATIGUE (Felt tired), EXTRA DOSE ADMINISTERED (Was given 3rd dose of Moderna covid-19 vaccine accidentally instead of Shingrix vaccine) and INTERCHANGE OF VACCINE PRODUCTS (accidentally administered Moderna covid-19 vaccine as third dose instead of shingrix vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Was given 3rd dose of Moderna covid-19 vaccine accidentally instead of Shingrix vaccine) and INTERCHANGE OF VACCINE PRODUCTS (accidentally administered Moderna covid-19 vaccine as third dose instead of shingrix vaccine). On an unknown date, the patient experienced PAIN IN EXTREMITY (Little sore arm) and FATIGUE (Felt tired). On 07-Aug-2021, EXTRA DOSE ADMINISTERED (Was given 3rd dose of Moderna covid-19 vaccine accidentally instead of Shingrix vaccine) and INTERCHANGE OF VACCINE PRODUCTS (accidentally administered Moderna covid-19 vaccine as third dose instead of shingrix vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Little sore arm) and FATIGUE (Felt tired) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient had completed her vaccination series in Feb-2021. Concomitant medication list was not provided. Treatment information was not provided.
I started to feel bad with cold like symptoms and could not taste or smell. I got a positive COVID-19 test. I was feeling fatigued with body aches and symptoms lasted for 4 days.
No adverse event; Patient received first dose on 22-Apr-2021 and second dose on 05-May-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 22-Apr-2021 and second dose on 05-May-2022) and NO ADVERSE EVENT (No adverse event) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 002c1A) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 2 diabetes mellitus, BPH, Hypertension and Drug allergy (Unknown historical drug).   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 22-Apr-2021 and second dose on 05-May-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 22-Apr-2021 and second dose on 05-May-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Patient received third dose as Moderna booster on 04-Jan-2022, batch number (041JZ1A) and anatomical location was reported as left arm.  Patient started to had Pfizer paxlovid drug (300-100 mg) on 03-Oct-2022 and stopped at 07-Oct-2022, Batch/lot number (1918538A) and indication used as (Treatment of COVID-19/COVID-19 Treatment)  Patient was taking a lot of Contact for a list as a concomitant medication.  Patient had body temperature and result were provided as 97.2 Fahrenheit and had BP with result as 140/79  On 11-Oct-2022 Patient had Paxlovid Rebound and tested positive (line extremely dark and immediate). It's back feeling cold like symptoms  runny nose, sneezing, stifles, nasal congestion and run down, no headache, no achiness. Chest and breathing good, no coughing and outcome for this was reported as recovering/resolving.  No treatment medication were provided.  Device Date : 12-Oct-2022
itchy lump at injection site developed on day 7 after initial inflamation had subdued, aprox 1 inch wide by half an inch tall
RT. Upper Arm has redness hot to touch and pain at injection site patient stated started next day of injection after exam, ice pack given to apply instructed to use Tylenol for pain referral given to see health care prvider or go to hospital if it is worse. Temperature 98F.
Patient was admitted to hospital on 10/11/2021 for planned procedure for partial cystectomy due to malignant neoplasm of dome of the bladder.  Patient was found to be COVID-19 positive during screening for post-acute placement. He remained asymptomatic for COVID-19 infection during admission and required no treatment. Patient was discharged to home with home health care on 10/15/2021.
5 days after admin. pt experienced numbnes in left arm. Described as a dead arm. Went to ER. No treatment given. MD determined possible side effect of vaccine.
This serious case was received from a consumer on 06 February 2009. A female patient reported that she received an injection of Tetanus/Diphteria vaccine (manufacturer and lot number unknown) three years ago, and subsequently experienced blurred vision, numbness in the arms and legs, and flu-like symptoms. The patient reported that a VAERS report had been completed at that time. Two months ago, she reported that she took a homeopathic remedy "made abroad from a Tetanus/Diphteria vaccine". She stated that since taking the homeopathic remedy, she had developed muscle rigidity, palpitations, and shortness of breath. She stated that she was currently under treatment of a physician. No additional information was provided.
Chills, shivering, fatigue, headache, sleepy, sore arm (difficult to lift).  Missed 1  day of work. Symptoms not fully diminished for 4 days.
bilateral pulmonary Emboli Infarct; she went on A-fib; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose number unknown (booster), single (Lot number: G13722) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (ongoing), notes: Blood pressure high. Concomitant medication(s) included: LISINOPRIL taken for hypertension; ATORVASTATIN taken for hypertension; CHLORTHALIDONE taken for hypertension. Past drug history included: Estradiol patch, notes: Estradiol patch (Suspect captured as per verbatim conservatively) 0.05milligrams and she is down that for 25 years. Vaccination history included: Covid-19 vaccine (Primary series of immunization complete, unknown manufacturer), for COVID-19 immunization.  The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "bilateral pulmonary Emboli Infarct"; ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "she went on A-fib". Therapeutic measures were taken as a result of pulmonary embolism, atrial fibrillation.  Clinical course: Reporter (Physician) stated, I have a patient. I am a Family medicine doctor, patient who had a Pfizer vaccine on 01Nov2022 and she had a developed a DDT (Event captured as per verbatim) several days later with bilateral pulmonary Emboli Infarct and so just wanted to add that to your database. Medical Conditions and Regular medications: Reporter stated, she does yes she has high blood pressure and high blood pressure medication she takes. You want the list of the meds? Lisinopril 20 milligrams, Atorvastatin 20 milligrams and she takes Chlorthalidone 25milligrams. Reporter stated, then she also was on Estradiol patch (Suspect captured as per verbatim conservatively) 0.05 milligrams and she is down that for 25 years. Treatment: Reporter stated, she is currently on Eliquis blood thinner, and we stopped her estrogen patch (Estradiol Patch) and she is also on metoprolol because she went on A-fib (Event captured conservatively as per verbatim).; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (PULMONARY EMBOLISM, ATRIAL FIBRILLATION) and BNT162B2. Based on known drug safety profile, there is reasonable possibility of causal association between the event and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Occassional rashes, raised hives, urticaria from the waist line to scalp.  No obvious trigger for allergic reaction excepting a new onset sensitivity to NSAIDs.  Before last vaccine Ibuprofen was used for occasional back pain.  Appr two weeks after initial rash and reaction (appr 4 weeks after third vaccination shot) ibuprofen was taken and within 45 min rash from waistline to scalp to include full torso was experienced.  Ibuprofen use discontinued after this and now appr 4 weeks later periodic rash appears along clavicle, across chest, upper arms and back of neck into scalp.  Rash and itching has been controlled by taking up to 50mg diphenhydramine orally.
I had severe pain in both shoulder for about 3 months starting from march to June and I finally went to the doctor and they did an assessment and said it was Bilateral shoulder tendonitis and recommended physical therapy and shoulder injections if they did not get better but they did so I did not need the injections. On 06/09/2021 I got shingles. For shingles they gave me Valtrex for 7 days. For my shoulder they did a full work panel but it came back normal except mildly elevated platelet count.
Barely can lift my arm; Red around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (Barely can lift my arm) and VACCINATION SITE ERYTHEMA (Red around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Barely can lift my arm) and VACCINATION SITE ERYTHEMA (Red around the injection site). At the time of the report, INJECTED LIMB MOBILITY DECREASED (Barely can lift my arm) and VACCINATION SITE ERYTHEMA (Red around the injection site) 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 and treatment medications were reported.
mom states Saturday noc 3 days p/vax pt had rash over back, abd, some on face;blotchy, raised like large welts;called ER was told to watch for diff breathing-no temp by morning all went away;
pt recvd vax 3AUG92 & 5 minutes following the vax, pt lost consciousness; exp a convuls described as deliriousness & thrashing; lost conciousness on & off up to 1 hr; BP dec to 95/50 & inc 100/70 w/pulse of 65;
Tongue swelling; Dry mouth; Burning; Body broke out in hives; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue swelling), DRY MOUTH (Dry mouth), ORAL DISCOMFORT (Burning) and URTICARIA (Body broke out in hives) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced SWOLLEN TONGUE (Tongue swelling), DRY MOUTH (Dry mouth), ORAL DISCOMFORT (Burning) and URTICARIA (Body broke out in hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWOLLEN TONGUE (Tongue swelling), DRY MOUTH (Dry mouth), ORAL DISCOMFORT (Burning) and URTICARIA (Body broke out in hives) 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.   No concomitant medications were reported.
injection site pain; headache; coughing; body aches; joint issue; Feel terrible; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: injection site pain), headache (Verbatim: headache), cough (Verbatim: coughing), general body pain (Verbatim: body aches), joint disorder (Verbatim: joint issue) and feeling bad (Verbatim: Feel terrible).The outcome of the injection site pain, headache, cough, general body pain, joint disorder and feeling bad were not reported.   It was unknown if the reporter considered the injection site pain, headache, cough, general body pain, joint disorder and feeling bad to be related to Arexvy.     It was unknown if the company considered the injection site pain, headache, cough, general body pain, joint disorder and feeling bad to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-SEP-2023 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient had all the side effects listed, he/she had joint issue, body aches, headache and injection site pain. The reporter stated that he/she also had some coughing.  The patient felt terrible. The follow up would not possible as no contact details were available.
Starting 15 hours after vaccination: body aches, chills, headache, uncomfortable breathing.  Symptoms subsided partly after 27 hours, and are very mild after 39 hours.
Treated in hospital for Right arm pain, fever of 101.0. Small bruise at injection site. 10-30-06 Patient complains of arm pain and swelling. Stated it is not any worse.
Headache off and on from about 30 minutes after shot for 4 days. Very itchy skin rash all over chest, stomach, back, arms, abdomen, thighs that started the day after the shot and still continuing today, April 22. Have flareups with intense itching and hive type welts. Skin is starting to peel in some areas but still itchy.
pt recv vax & the next day pt exp swollen eyes & fatigue;MD visit was required;tx w/DPh;sx resolved as of 28NOV96;