chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hoarseness in throat; flu like symptoms; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Hoarseness in throat), INFLUENZA LIKE ILLNESS (flu like symptoms) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPHONIA (Hoarseness in throat), INFLUENZA LIKE ILLNESS (flu like symptoms) and NAUSEA (nausea). At the time of the report, DYSPHONIA (Hoarseness in throat), INFLUENZA LIKE ILLNESS (flu like symptoms) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines were not included.  Treatment medications were not provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant FU -AE Outcome Provided and FU declined
I had flu shot, 9 hours later I had severe vomiting and diarrhea that lasted into the early morning hours.
got really sick; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (got really sick) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got really sick). At the time of the report, ILLNESS (got really sick) 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.   Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-568298 (Patient Link).
This spontaneous report was received from a healthcare professional referring to a 12 months old female patient. Information about the patient's medical history and concurrent conditions was not reported. On 13-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all schedule follow up information was received.
Vomiting milk; skin felt hot about to give Tylenol, when he started shaking all over. Could not see him breathe, did not respond to her voice. Called Rescue Squad shaking lasted "for a few minutes" then saw child breathing; not responsive.
I experienced excruciating pain in my mouth.; This is a spontaneous report from a contactable pharmacist reporting for a herself. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot # EK5730) via intramuscular in right arm on 16Dec2020 07:00 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient received the vaccine in hospital. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of vaccination included birth control only. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced excruciating pain in her mouth at 17:00 on 20Dec2020. It lasted for four days. The patient visited a dentist, x rays and exam found no infection, no cavities, and no inflammation. Methylprednisolone (MEDROL) dose pack and antibiotic were given even though nothing was found. The event resulted in "doctor or other healthcare professional office/clinic visit". Since the vaccination, the patient had not been tested for COVID-19. The outcome of event was recovering.
Pharmacy error: The Moderna vaccine with lot # 003C21A that was sent out on 11/24/21 to our clinic should have the absolute expiration date of 12/17/21 and not 12/24/2021.
7 cm x 7 cm erythema, warm, sore. Rx-None
This spontaneous report as received from a pharmacy technician refers to three patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23 (lot# M000386; dose, route of administration and expiry date were not reported). There were no concomitant therapies reported. On unknown dates, the patients experienced rash, swollen and sore arm at the injection site. The outcome of the events was not reported. The relatedness between PNEUMOVAX 23 and the events was not provided. This is one of two reports received from the same reporter. Additional information has been requested.
Patient received a third dose of the moderna covid vaccine bedside at a medical facility. A VAR form was provided and staff of the medical facility stated this was the patients second dose and not third dose. After further investigation, it was discovered the dose we provided was the third dose. There were no immediate ADRs.
I had loss of taste and smell.  I was fatigue.  I had SOB and headache.  These symptom are still ongoing.  I went to the doctor.  They did EKG.  I did a COVID-19, positive result.
throat swelling and a fever began 1/11/21 after getting my first dose on 1/8/21. My fever cleared overnight but the throat swelling persists today.
03/16/2021 7:48PM, while walking from one room to another doing mild physical activity, became slightly dizzy, walked to chair and sat down, heart rate immediately skyrocketted to over 200bpm and persisted to be at etremely high rate for about 5minutes. Max BPM 218 avg bpm 209, painful chest and neck pressure/pulsating. No fever/cough or any history of any heart conditions in immediate or distant family. ER visit 03/24/2021 with persistent chest palpitations lasting 5+hours bearing down did not resolve and rate readings captured via smartwatch, ER visit 03/31/2021 for high heart rate lasting 10minutes with no exercise involved, sitting, bearing down did not resolve.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Dec-2022 and was administered on 02-Feb-2023) and NO ADVERSE EVENT (no adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis. No Medical History information was reported.No concomitant information was reported.  Dosage text of the suspect was reported as unknown. It was reported that 7 doses were administered and the size of the vial was 2.5ml. Vaccine was administered to 2 patients on 31-Jan-2023, 2 patients on 02-Feb-2023 and 3 patients on 10-Feb-2023. The vial did not underwent any temperature excursion and the BUD date was 28-Jan-2023.  No treatment information was provided.
started 27AUG96 sleeping pattern changed-dispasm changed-cried alot;did not sleep much;no fever;area of inj hot to touch & a lump;no redness;seen by MD 5 days later-no apparent problems or illness;MD stated d/t pertussis-no more;
After 1st injection (1/11/21)  experienced severe shortness of breath with minimal activity with accelerated heart rate and drop in O2 stat. within 2 days of injection then developed wheezing cough. Primary MD prescribed Augmentin nd prednisone with eventual success.  With normal blood work, chest x-ray and negative Covid test all done by 1/15.  On 3/9/21 (28) days after second dose (2/11/21) experienced burning and swelling on right leg. Went to Hospital, ER and found extensive blood clots in right leg and saddle pulmonary embolism .  Also had 50% Platelet blood count decrese since the 1/15 bloodwork Admitted for 3 nights on heparin dip. Discharge on home Lovenox injections for 30days.
Pt recvd 3 doses of Engerix-B 26JAN90, 20APR90 & 13JUL90 & AUG91 titers tested & it was discovered that the pt did not convert antibody;
Tightness, tenderness in thyroid area across the throat/lowest part of front of neck (not airway constriction but on the outside). Severe heartburn, burping and reflux, anxiety, slightly elevated heart rate about 30 mins after injection, lasting about 30 mins. 5 hours after injection, after eating a small snack, repeat of heartburn, burping and reflux. Felt hot but temperature 97.7, then chills briefly.  Anxiety and related fast heart beat and shallow breathing for about 1 hour. Took benadryl, no change.
14Oct85 pt vax w/ hepta B; p/ 1 month pt ex morning stiffness, pain + swelling of neck, shoulders, elbows, hands + feet, petechial or erythematous skin lesions and malaise;  Tx w/ naprosyn, sulinac, motrin, and azudimidine.   see worm...
Information has been received from a women at a pediatrician's office concerning a 24-month-old Caucasian female with a history of assymetric lung fields, who on 05-MAY-2005 was vaccinated subcutaneously in the right thigh with a first dose of Varivax (lot # "0457P"). Concomitant vaccination given on the same day included a fourth dose of PREVNAR (lot# A57561F) given intramuscularly in the left thigh. There was no illness at the time of vaccination. On 14-MAY-2006 the patient developed a fever of 101 degrees Fahrenheit and rash on her legs, arms, head, chest and back. The patient was treated with TYLENOL. No medical attention was sought. The outcome was unknown at the time of this report. Additional information has been requested.
pt recv vax 2FEB96 & vomited 3 times & devel persistent screaming & crying, lasting 4 to 6 hrs, as well as a fever of 99;pt has recovered;
Chills; Tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for an unknown indication.     The patient's past medical history included COVID-19 in March 2020. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 07-Jan-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Body temperature: 102 °f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for these events included acetaminophen.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Bell's palsy 6 days after vaccine, mild to moderate, unresolved at this time
A LITTLE BIT OF PAIN IN THE CHEST; HURTING ALL OVER; FEELING SICK TO STOMACH; This spontaneous report received from a consumer concerned a male of unspecified age. 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: unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 07-APR-2021, the subject experienced a little bit of pain in the chest. On 07-APR-2021, the subject experienced hurting all over. On 07-APR-2021, the subject experienced feeling sick to stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from a little bit of pain in the chest, hurting all over, and feeling sick to stomach. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard  procedure as the case was assessed as non-serious.
Ineffective breathing: I was sitting on a couch with two people, and I was the only one who felt like I wasn't getting enough air while taking full, steady breaths. We had the windows open, so it definitely wasn't because of poor ventilation or carbon monoxide.
Chills, Headache, Body aches, weakness (unstable standing up), nausea (throwing up)
27 yr. old female.  Pain in upper chest. Lump in upper left chest as well as swollen and tender lymph glands in left shoulder.  Seen by infectious disease physician, on 3-25-2003, Day 8 post vaccination. No time lost from work. No treatment.
2 days p/vax pt devel pain,swelling,redness(2 inches in size)& infection.
male patient was accidently given Tenivac instead of TDap with no adverse event; Initial information received on 13-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an adult male patient in his 40's who was accidently given DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [TDAP].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 12-Jul-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot number and expiry date: not reported) (Frequency: once) instead of TDAP not produced by Sanofi Pasteur via an unknown route at an unknown administration site (Wrong product administered) for prophylactic vaccination.  It was an actual medication error case due to Wrong vaccine administered (latency on same day).  It was reported that "Practitioner reported that a patient was accidently given TD instead of TDap on yesterday. Caller would like to know when can TDap now be administered to this patient. The Practitioner reported that the patient that received the Tenivac and not the ordered Tdap is in their 40s and is a male and that the dose of TDap was ordered was to be able to be near a newborn. The Practitioner was not able to provide any more information for this report due to not being in the clinic".   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
syncope; This spontaneous report was received from a nurse via a company represenatative and refers to an unspecified patients. Information regarding concomitant therapy, concurrent condition and medical history were not reported. On an unknown date, the patients were vaccinated with GARDASIL, intramuscular (dose, frequency, lot# and indication not provided). Other suspect therapies included GARDASIL 9 (dose, frequency, lot# and indication not provided). The reporter stated that it was unspecified that whether product involved was GARDASIL or GARDASIL 9. The reporter also stated that syncope was always a concern with GARDASIL or GARDASIL 9. The outcome of syncope was unknown. Causality assessment was not provided. No additional information was provided regarding these unspecified patients. This is one of two reports received from the same reporter. Additional information is not expected as no consent to contact the reporter.; Sender's Comments: US-009507513-1707USA001763:
Pt was in waiting room after her COVID booster vaccine.  She received the COVID booster about 10-15 minutes after her flu shot.  About 10 minutes after the COVID booster., she reported becoming hot and feeling like she "needed to get some air".  She began coughing and stated it felt like something "hard" was stuck in her throat.  She coughed very hard to point she was gagging and throwing up mucous.  After throwing up small amount of phlegm she reported feeling better.   BP during cough was elevated but came back down.  O2 sats normal.  Patient denied feeling like throat was swelling or any mouth tingling.  Denied itching.  No rash.  Was held 1 hour and was feeling herself again with normal VS.
pt exp circumoral numbness & tingling to extremities the day p/vax;sx lasted for approx 4-6hr;no tx was sought by patient;
Patient has been sick for a month with sore throat, lymphadenopathy, malaise. Has not recovered. Feels like throat is getting worse.
Injection site pain; Injection site rash; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and injection site rash. On an unknown date, the outcome of the injection site pain and injection site rash were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site rash to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's husband. The age at vaccination was not reported. The patient was vaccinated with Shingrix and experienced injection site pain and injection site rash. This was 1 of 4 cases reported by same reporter. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020201572:same reporter US-GLAXOSMITHKLINE-US2020201575:same reporter US-GLAXOSMITHKLINE-US2020201578:same reporter US-GLAXOSMITHKLINE-US2020AMR202100:same reporter
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 78 year old patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On 14-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 14-Sep-2016, doses were administered. Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature of, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-MAY-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
On 8/6/14 noted very large hot to touch at injection site. Also tender to touch. Pt. called office on 8/7/14 and came to office to evaluate. Right arm grapefruit size red, hot to touch area, pt also states that 8/6/14 area itched and her lips felt "funny". Took BENADRYL in 8/6/14, today just itchy area. RPH evaluated injection site and pt. advised to use BENADRYL, ibuprofen ad ice - ZOSTAVAX added to allergy/intolerance.
Patient only 17 years old (underage); interchange of vaccine product; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient only 17 years old (underage)) and WRONG PRODUCT ADMINISTERED (interchange of vaccine product) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient only 17 years old (underage)) and WRONG PRODUCT ADMINISTERED (interchange of vaccine product). On 01-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient only 17 years old (underage)) and WRONG PRODUCT ADMINISTERED (interchange of vaccine product) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This report refers to a case of Wrong product administered and product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number unknown) with no associated AEs.
Pt delivered stillborn infant 11/25/05 32 weeks and 5 days gestation.