chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 1/2 hours after the flu mist was given my son broken out in a severe rash on this legs and feet. I called the covering doctor and was told "it is totally unrelated".  I gave my son benadryl and put 1% hydrocortisone cream all over his rash.  In the morning it has spread to his buttocks and his arms. I took him back to the doctor who told me it may or may not be a reaction to the flu mist. I was told to purchase Clarinex and 1% hydrocortisone ointment and it would take about a week to clear up.
Day 1-3 6 hours s/p flu shot felt unwell, cold, shaking uncontrolled, lasting 6 hours. Fever 104.0, hot flashes, insomnia, vomiting, dizzy, unsteady gait. Day 4 9/24/12 referred to Dr. Mon & Wed. SOB, chest discomfort, EKG.
Extreme fatigue, headache, loss of appetite, joint ache, sore at injection site
Information has been received from an office manager and a consumer who reported that she had seen reports of deaths following GARDASIL on television. This is one of two cases from the same source. This is a hearsay report in the absence of an identifiable patient. All telephone attempts to obtain follow up information have been unsuccessful.
Information has been received from a consumer concerning her 4 year old son with no drug reactions or allergies who, "about 3 years ago", in approximately 2006 was vaccinated with a first dose of VARIVAX (Merck). "A few days ago", on 17-FEB-2009 the patient developed a breakthrough of chicken pox and had less than 20 lesions. Unspecified medical attention was sought but not laboratory test was performed. The patient was scheduled to receive his second dose of VARIVAX (Merck) in the next two weeks. At the time of this report, 18-FEB-2009, the event persisted. The patient's twin brother also experienced an AE following vaccination (WAES# 0902USA04167). Additional information has been requested.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Moderna vaccine was ordered on 03-Jan-2022.  The beyond use date of the vaccine was reported as 02-Feb-2022.  The reporter reported that they had a group of 13 pharmacies that had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware that in some of the freezers there was a temperature excursion that their data logs showed.  They wanted to reach out to see if the vaccines had been compromised. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures.  The reporter asked whether they need to take any action in relation to the doses administered since the vaccines were stored in an unapproved freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  No treatment information was provided.
have a Moderna COVID 19 vaccine and it's got a 30 day BUD out of the freezer; Vial got a 30 day BUD out of the freezer and I had someone administer it past that.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial got a 30 day BUD out of the freezer and I had someone administer it past that.) and PRODUCT STORAGE ERROR (have a Moderna COVID 19 vaccine and it's got a 30 day BUD out of the freezer) in a 73-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 054A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial got a 30 day BUD out of the freezer and I had someone administer it past that.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (have a Moderna COVID 19 vaccine and it's got a 30 day BUD out of the freezer). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial got a 30 day BUD out of the freezer and I had someone administer it past that.) and PRODUCT STORAGE ERROR (have a Moderna COVID 19 vaccine and it's got a 30 day BUD out of the freezer) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The vail was initially stored from freezer to refrigerator on 31-May-2022 at 4 PM. The vaccine was administered on 01-Jul-2022 between 9 AM to 12 noon. The vial did not undergo any temperature excursions. it was reported that, the days were miscalculated.  No treatment details were reported.
folliculitis of hair follicles on legs arms and back after receiving both Moderna doses; This spontaneous case was reported by a consumer and describes the occurrence of FOLLICULITIS (folliculitis of hair follicles on legs arms and back after receiving both Moderna doses) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FOLLICULITIS (folliculitis of hair follicles on legs arms and back after receiving both Moderna doses). At the time of the report, FOLLICULITIS (folliculitis of hair follicles on legs arms and back after receiving both Moderna doses) outcome was unknown.            No concomitant medication reported. No treatment information was provided. The patient had folliculitis of hair follicles on legs arms and back after receiving both Moderna .   This case was linked to MOD-2021-405053 (Patient Link).
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild.
flu; got sick; Initial information received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/Non-Healthcare Professional via Social Media.  This case involves an unknown age and unknown gender patient who experienced flu (influenza) and got sick (illness) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date (15 years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) and got sick (illness) (right after) following the administration of INFLUENZA VACCINE.  Other relevant lab data was not reported.  It was reported "Haven't had the flu shot since and never will. I'll take my immune IV over any shot, keeping my Vitamin D levels high, eating healthy and exercising. It is unknown if the patient experienced any additional symptoms/events."  It was not reported if the patient received a corrective treatment for the events (flu, got sick).  At time of reporting, the outcome was Unknown for the event flu and sick.  There will be no information available on the batch number for this case.
Both arms started to get red, swollen, bruising, and tightness in muscles next day after receiving immunization.  Dark rash noted after mother placed Hydro. creme on arm that was perscribed by MD at ER visit.  treated with benedryl, amox., and Ibuprofen.
never completed primary vaccination series before receiving a dose of the bivalent vaccine.; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (never completed primary vaccination series before receiving a dose of the bivalent vaccine.) and NO ADVERSE EVENT (No Adverse event) in a 20-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Nov-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (never completed primary vaccination series before receiving a dose of the bivalent vaccine.) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (never completed primary vaccination series before receiving a dose of the bivalent vaccine.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (never completed primary vaccination series before receiving a dose of the bivalent vaccine.).    Concomitant medications were not reported.  Patient received first Moderna shot was on 25AUG2022 (lot number 053B22A). Treatment medications were not reported.
Patient received vaccine, was sitting in waiting area and passed out not even 5 minutes after receiving the vaccine. Patient was sitting down at the time so he slid down his chair but mother caught him before he fell out of chair. Patient was out for a few moments then came to again. Patient was given water to help him. Mother and patient sat in waiting area until he felt better and communicated to her he was okay to leave and then they left to go shopping in the store.
symptoms: soreness on the injection site, fatigue, mild fever, and headache. no treatments needed. symptoms subsided in 2 days. no serious health outcomes to report
Sudden onset of intense muscle spasms in back, down the legs to the knees.  Intense pain for 3 days.  Moderate pain for 5 days.  Ongoing soreness and weakness in back continues even after second shot.  The doctor recommended taking the second shot, but prescribed muscle relaxants.  Unsure of permanent damage.
Itching started in feet immediately after shot.  Weird pain in lower middle back.  Itching progressed to entire body after about an hour.  Took 12.5 mg Benadryl, then took 12.5 mg two hours later. Next day arm was swollen and aching, itching continued.  Took 625 mg Tylenol Arthritis, 25 mg. Hydroxyzine every 8 hours for two days.
limb immobility - 6 days past, cannot yet abduct or flex beyond 90 degrees
Fatigue, watery diarrhea <15/day, severe abdominal pain, nausea, vomiting, loss of appetite, general malaise, low grade fever going on for more than 3 days now. My health insurance is still not active due to being a new employee and I cannot seek medical care at this time.
Patient received the third dose of Engerix 4 weeks after the second dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 10-year-old female patient who received HBV (Engerix B pediatric) (batch number MY3RA, expiry date 21st September 2022) for prophylaxis.   Concomitant products included HBV (Engerix B pediatric).   On 13th May 2021, the patient received the 3rd dose of Engerix B pediatric. On 13th May 2021, unknown after receiving Engerix B pediatric, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were reported as follows: The patient received 3rd dose earlier than the recommended time frame, which led to shortening of vaccine schedule. The reporter did not consent to follow up.
pt recv vax 20OCT97 & 21OCT97 3AM mom noted pt to be hot-temp 103 ax despite APAP being given since vax as directed;pt limp, lethargic, eyes rolled back & had projectile vomiting;mom gave pt tepid bath, drops of apple juice;
Five hours post vaccination generalized achiness, fatigue and very sore arm. Swollen lymph nodes to neck on Left began approx 10 days post vaccination.
Upon return for a second dose on 04/01/2022 patient reported a positive COVID test on 01/06/2022.  Symptoms were mild and abated within a few days.
This spontaneous report as received from a nursing assistant. No patient is involved. On an unknown date, there was product confusion between the color of the vial of (Merck) VARIVAX and the color of the diluent that (Merck) VARIVAX comes with. The colors of the labels were similar. Because of the color confusion the (Merck) VARIVAX was accidentally left out of temperature range as it was believed to be the diluent. A product quality complaint (PQC) was not identified. This is one of several reports received from the same reporter. Additional information has been requested.
COVID-19; DEHYDRATION; Diarrhea; Nausea; Vomiting; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19), DEHYDRATION (DEHYDRATION), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19), DEHYDRATION (DEHYDRATION), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, COVID-19 (COVID-19), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown and DEHYDRATION (DEHYDRATION) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   ?No treatment information was provided. ?   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up added. New events added.
Stomache ache; Body aches; fever; chills; Headache; A spontaneous report was received from a consumer concerning a 61-year-old female patient who experienced fever: pyrexia, body aches: pain, chills: chills, headache: headache, stomach ache that come and go: abdominal pain upper.  The patient's medical history included COVID-19 in November 2020.  Concomitant product use were not provided by the reporter.  On 28-Dec-2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (lot number 036K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 29-Dec-2020 the patient developed a fever of 99.4° to 101.7°, body aches, chills, headache, and stomach aches that come and go.  The events were treated with Tylenol on 29-Dec-2020.     Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events pyrexia, body aches, chills, headache, and stomach ache that come and go were unknown.   Reporter causality for the events was not provided.; Reporter'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.
I tested positive for Covid 19 on September 10, 2022  I experienced a cough and congestion and lethargy. I was prescribed Paxlovid for my symptoms.
Sore, red raised left lower arm 2 days post MMRX VARIVAX vaccine.
Significant swelling in armpit area of the arm where injection was given. Pain lifting and lowering arm and from swelling and skin rubbing due to swelling.
Syncope; Injection site pain; Injection site swelling; Nausea; Vomiting; This case was received (Reference number: 1063219) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hyperlipidemia, Diabetes mellitus, GERD and Hypertension. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), METFORMIN, LISINOPRIL and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 27-Feb-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain), INJECTION SITE SWELLING (Injection site swelling), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, SYNCOPE (Syncope), INJECTION SITE PAIN (Injection site pain), INJECTION SITE SWELLING (Injection site swelling), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt recv vax & was brought to ER in a state of sz; exam @ ER revealed that pt had stiffed up & had become unconscious & turned blue w/low 02 saturation; the 02 level came up & the sz subsided; pt had CBC, lytes, & CBC @ ER; given IV Valium
Autoimmune muscle disease. Dermatomyositis. Muscle weakness, fatigue, purple patches on skin. 9/23/08-records received-office visit 04/27/07-seen for contraception follow up received 1st HPV vaccine. 6/20/07-second HPV vaccine. 10/23/07-3rd HPV vaccine. No office visits documented between vaccinations. 3/14/08-C/O stomach pain after dairy. Continues to use Loestrin 24 BCP. 7/15/08-C/O autoimmune disorder. Muscle pain and weakness. Dermatomyositis. 8/20/08-has been using Yaz BCP now having difficulty with increased bleeding and period lasting longer. 9/11/08-DX dermatomyositis.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In approximately 2016 (since 08-FEB-2016), the patients were vaccinated with improperly stored doses of PROQUAD lot # L039269, expiration date 05-APR-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of -13 degrees Celsius for 65 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. states arm pain (sore) when lifting arm. Administered 9/2/11. Today is 12/2/11.
Information has been received from a physician concerning a 19 year old female who in 2008 was vaccinated with the first dose of GARDASIL (lot # not reported). The patient did not complete the series. On 03-OCT-2010 the patient was found high grade squamous intraepithelial lesion (HGSIC) High Risk HPV, CIN II Bx by cervical smear (PAP). The patient's outcome was unknown. Additional information has been requested. This is one of several reports from the same source.
Swelling of the right side of the abdomen, pain in the upper right part of the abdomen.
Trembling of limbs (hands); Numbness in palms/fingers; Burning in chest; Hot forehead; Sweating; Weakness; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp. A 11-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FK5127), via an unspecified route of administration, administered in Arm Left on 09Nov2021 18:45 as(Age at vaccination 11 Years) DOSE 1, SINGLE for covid-19 immunisation. Medical history were none and there were no concomitant medications. No other vaccines were received within 4 weeks prior to the COVID vaccine and No other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient was not tested for COVID-19. On 09Nov2021 18:55, The patient experienced trembling of limbs, numbness in palms/fingers, burning in chest, hot forehead, sweating, weakness, dizziness. Therapeutic measures were taken as a result of trembling of limbs (hands) (tremor), numbness in palms/fingers, burning in chest, hot forehead, sweating, weakness, dizziness. Hydroxyzine treatment received for the adverse event. The outcome of the events was recovered on unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.