chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fatty liver disease; sore arm; little dizziness.; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC STEATOSIS (fatty liver disease), PAIN IN EXTREMITY (sore arm) and DIZZINESS (little dizziness.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     Concurrent medical conditions included Hepatic steatosis.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and DIZZINESS (little dizziness.). On 08-Jun-2021, the patient experienced HEPATIC STEATOSIS (fatty liver disease). On 01-Jun-2021, PAIN IN EXTREMITY (sore arm) and DIZZINESS (little dizziness.) outcome was unknown. At the time of the report, HEPATIC STEATOSIS (fatty liver disease) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jun-2021, Alanine aminotransferase increased: increased (High) Increased values by about 20 points.. On 08-Jun-2021, Aspartate aminotransferase increased: increased (High) Increased values by about 20 points..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported  No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up received: contains Non-significant information.
Pt came back after 20 min w/ a lacertine rash & lip tingling. She did not think she was allergic to any of the ingredients & had said no to all questions. Known sulfa, TRICOR, & peanut allergy. Our nurse practitioner briefly saw her & recommended OTC BENADRYL, pt took 2 of them (50 mg).
itching; swelling on arm; red spots; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (itching), PERIPHERAL SWELLING (swelling on arm), ERYTHEMA (red spots) and CHILLS (chills) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high.    On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PRURITUS (itching), PERIPHERAL SWELLING (swelling on arm), ERYTHEMA (red spots) and CHILLS (chills). At the time of the report, PRURITUS (itching), PERIPHERAL SWELLING (swelling on arm), ERYTHEMA (red spots) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications of the patient included diabetes medication and high blood pressure medication.  No treatment information was provided by the reporter.
COVID 19- I Tested positive on July 2, 2022 I experienced a high fever of 102.4 on the first few days, Coughing, Brain fog, loss of energy, Sinus congestion, difficulty breathing . I was taking Sinus medication, Nyquil, & Mucinex.
some of the vaccine went down her arm.; vaccine went down her arm; vaccine went down her arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st December 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 05-DEC-2022 Reporter's Comments:  The reporter reported that the patient received her Shingrix vaccine in the right arm.  The reporter was injecting the Shingrix vaccine the patient pulled away and some of the vaccine went down her arm.  The reporter was consented to follow up. Additional supportive information: The reporter reported that he injecting the Shingrix vaccine and patient pulled away some of the vaccine went down her arm, which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact.
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was provided. A vial was punctured 30 times at the clinic. 10 patients who were administered the vaccine were affected. No treatment medication details was provided.
Patient received ZOSTAVAX and came back in with red and inflamed at site of injection about 2 inches in diameter.
Swelling (8 cm diameter), inflammation, and tenderness at injection site.  Body aches, back and hip pain, general malaise and lethargy.
Red raised area length 16cm x 11cm wide warm to touch - no rash - able to move arm - full ROM equal hand strength advised to seek rec. of MD.
Patient felt dizzy and very weak about 30 minutes after vaccination.  He was coherent but very weak.  needed to be taken by ambulance
vaccines reaction on right arm  Vaccines were administered on 03/16/21. Hep A and MMR. Pt states redness and small bump on the area. No fever, chills ,cough cold vomit diarrhea headaches  body aches or SOB
fever (max 104.5 (R) F) & generalized tonic-clonic sz (< 15 minutes) w/out detectable neurolgic sequaelae
Two weeks after the 2nd vaccine, experienced lymph node inflammation which manifested itself in muscle twinges all over body.
Redness at vaccine injection site, some localized swelling, relieved with benadryl.
BELL'S PALSY; SUDDEN ONSET OF CHEST PAIN; DIAPHORESIS; SKIN COLOR GRAY; BLOOD PRESSURE ELEVATED; RIGHT LEG WEAKNESS; PAIN IN MULTIPLE AREAS OF HIS BODY; REMAINS WEAK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no history of strokes or Bell's Palsy and also had no prior history of blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total administered, start therapy date were not reported 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 numbness to right side of face, asymmetrical smile, high blood pressure, also during admission patient had sudden onset of chest pain, diaphoresis, skin color gray. After the patient got discharged from the hospital diagnosed with bell's palsy and developed right leg weakness ,facial palsy also moved to left side of face. The patient stayed in hospital for another three days and got discharged with multispecialty follow ups, and also remained weak along with pain in multiple areas of patient body. On an unspecified date patient hospitalized for bell's palsy, chest pain, diaphoresis, skin color gray, blood pressure elevated and right leg weakness. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) with reported result as elevated, and Stroke work up (NR: not provided) result unknown. Treatment medications (dates unspecified) included: glyceryl trinitrate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sudden onset of chest pain, diaphoresis, and skin color gray, had not recovered from right leg weakness, pain in multiple areas of his body, and remains weak, and the outcome of blood pressure elevated and bell's palsy was not reported. This report was serious (Hospitalization Caused / Prolonged); Sender's Comments: V0-20210944356-Covid-19 vaccine ad26.cov2.s- Bell's palsy,  sudden onset of chest pain, diaphoresis, skin color gray, blood pressure elevated .This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210944356-Covid-19 vaccine ad26.cov2.s-Right leg weakness. This event(s) is labeled per RA and is therefore considered potentially related.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 22-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL, 0.5 ml, intramuscular. No adverse effects was reported. Action taken was not applicable. The outcome of incorrect product storage and no adverse effect was unknown. Additional information has been requested.
Increased redness, swelling at site to left arm. Induration 20 mm. Skin intact. Area tender to touch. Denies pain at this time. Swelling x 2 days.
7 days after shot, injection site hurts to the touch, feels a little hot, its swollen and itchy
I had a large grapefruit size red spot come up that was painful and was hard under the skin.
Shortly after leaving the facility, after waiting the required 15 minutes post vaccine, I was driving back home on the freeway when I suddenly felt light-headed and as though all the energy had left my body (as though I was about to pass out). Then, without warning, I passed out, while driving on the freeway. Fortunately, I did not hit anyone, or was hit by anyone, and must have bounced off guardrails after crossing traffic twice and going off the freeway into the middle of an off ramp, where I finally came to. I did not suffer any injuries in the accident.
dose was diluted incorrectly with 2.0mL of diluent instead of 1.8mL
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 11-JUL-2017 and 12-JUL-2017, unspecified number of patients were vaccinated with improperly stored doses of VARIVAX lot# N002204 with expiry date: 19-JAN-2019 (dosing details, route were unknown) for prophylaxis together with sterile diluent (MERCK) (dose, frequency, lot #, expiry date and indication were not reported). It was reported that the vaccines were exposed to a temperature range of 6 F to 14 F for a duration of 1 hour. Data Logger was involved. No adverse effects were reported. There were no previous temperature excursions. This is one of the two reports from the same reporter. Additional information has been requested.
Within 24 hours post vax pt developed a fever of 101F and a red, raised rash on her face, hand and at the injection site. Pt was also fussy. The fever abated within one day.
SX: HIGH FEVER, HIGH BLOOD PRESSURE DX: MYOCARDITIS INFLAMMATION LAB TESTS: HIGH TROPONIN, ELEVATED INFLAMMATION MARKERS, ECG SHOWED MYOCARDITIS INFLAMMATION TX: HOSPITAL ADMISSION X 4DAYS IV FLUIDS/ELECTROLYTES ANTIBIOTICS DISCHARGE MED: CARVEDILOL OUTCOME SYMPTOMS IMPROVING BEFORE DISCHARGE
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 27May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. There was no known allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jun2022, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid for COVID 19 from 25Jun2022 to 30Jun2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have been really tried in since April 2021, I don't even have to eat, I am so tried and I have to take a nap. I am not usually a person who has to take a nap. It's so bad that I don't even hear my kids. I notice that this started right after I got the second vaccine. Major fatigue.
"I received the Johnson & Johnson COVID-19 vaccine on April 10. I felt a little bit woozy a few hours after getting the vaccine. About 2 days after the vaccine, my upper lip was swollen for a few hours after I woke up. This week (about 9-10 days after the vaccine), I noticed red spots and very small bumps on my body, specifically on my left breast, below breasts, and lower stomach areas. It does not itch or hurt. I dont seem to have any other symptoms. I have not had any new foods or used any new products on the affected areas. "
Patient is only 17 years old as should not have received Flublok as it is indicated only for 18 years old and over. No known complaints of side affects
This case was reported by a nurse and described the occurrence of abnormal menstrual cycle in a 37 year old female subject who was vaccinated with Twinrix plus a separate injection of tetanus and diphtheria toxoids adsorbed. Medical history included food allergies (non-egg), chronic asthma, fibromyalgia, non smoker, non drinker and no known drug allergies. Concurrent medications included Birth control pills. On 10 February 2006, the subject received 1st dose of Twinrix (lot AHABB026AC) plus a separate injection of Tetanus and diphtheria toxoids (lot U13408A). On 10 February 2006, at an unspecified time following receipt of the vaccinations, the subject "received her menstrual cycle." The subject was seen at a physician's office and was treated with progesterone. The menstrual cycle "stopped with the progesterone" on 14 March 2006. The nurse reported the outcome as resolved with sequelae. The nurse considered the event to possibly be related to vaccination with Twinrix and tetanus and diphtheria toxoids adsorbed.
Vaccinated on 7/24/03 with DTaP, MMR, IPV. Redness and swelling and warm to touch. Rx with Tylenol 2 tsp every 4 hours for pain.
Covid arm - severe swelling, bruising, rash etc. from shoulder to elbow. Particularly bad for 4 days then subsided. Intense chill for 4 hours followed by fever (2 days),  headache, waves of nausea and intense fatigue (4 days). Residual fatigue and nausea (2 days)
Cardiac issues - chest pain, arrhythmias, possible pericarditis/myocarditis, fatigue, SOB
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves female patient who experienced FLUZONE QUADRIVALENT given to employee today subcutaneously, while she received vaccine FLUZONE QUADRIVALENT. 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 INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via subcutaneous route. It was a case of actual medication error due to Inappropriate route of vaccination. The patient outcome is reported as Not Applicable for fluzone quadrivalent given to employee today subcutaneously. 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.
2 hrs after injection, bruised feeling on arm and left side of face, 4-5 hours later when chewing food  was difficult on left side of mouth; Overnight into morning tongue swelled
Accidental full dose (0.5ml) given instead of half dose (0.25ml) administered in RVL. Next morning, mother reports area warm to touch, swollen and red. Patient was evaluated; placed on Bactrim supervision and Orapred orally. Mother reports child fine 10/21/05.
Hives the day of each vaccine, hives returned worse 4 days after 2nd vaccine and had to go to emergency room.  medication administered and medication sent home, missed work for 2 days. Still taking medication (Prednisone, Atarax, Pepcid, EpiPen Auto Injector as needed)
The vaccine DTaP was given instead of Tdap for the patients 11 year old vaccinations. No symptoms or signs of a reaction occurred in the office.
Mother brought child in for H1N1 shot at public clinic 10/27/09. Filled out yellow sheet which was filed with that schools papers. She brought the child in for 2nd shot at public clinic in Nov. 17, 2009. There was a message sent out the night before that if your child had received the vaccine elsewhere to let the school know. Parent did not call school so child received 3rd H1N1 at school 12/14/09. No problems noted, no s/s of adverse rxn.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 3:10 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 3:10 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions was reported.  No treatment medications were provided.  Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.
get sicker than ever before; Initial information received on 10-Oct-2021 regarding an unsolicited valid social media non-serious case received from a non-healthcare professional under (reference: US-SA-SAC20211015000546).  This case involves a patient of (unknown demographics) who got sicker than ever before (illness) when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event got sicker than ever before (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  The event outcome was unknown for the event (illness).  There will be no information available on the batch number for this case.
HIGH FEVER; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of high fever was not reported. This report was non-serious.
administration of an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number AN599, expiry date 8th November 2022) for prophylaxis.   On 11th November 2022, the patient received Engerix B. On 11th November 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 11-Nov-2022 Reporter's comment:  A health care professional called to ask for information about the administration of an expired dose of Engerix-B to a patient. The reporter asked if the patient would be re vaccinated.  The reporter did not provide patient identifiers.  The reported did not consent to follow-up Additional Supportive Information: The patient was administered an expired dose of Engerix-B, which led to expired vaccine used.
11/19/07 began with abd. pain and vomiting. taken to ER in Findlay in evening, discharged to home when vomiting ceased.  symptoms continued that week and febrile suppositories given. on 11/24/07 taken to PCACC and xray, CT scan done. transferred to Hospital and had surgery for intusseption. 1/9/08-records received for DOS 11/24-11/28/07. DC DX: Intussusception. Laproscopic reduction of ileocolonic intussusception. Five days prior to admission developed abdominal pain and emesis. Bowel movement present with bloody mucus 2-3 days prior to admission.