chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; given vaccine past the manufacturer's expiry date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given vaccine past the manufacturer's expiry date) and NO ADVERSE EVENT (No adverse event) in an 11-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2022 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2022 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine past the manufacturer's expiry date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given vaccine past the manufacturer's expiry date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (given vaccine past the manufacturer's expiry date).    No concomitant medications were reported.  The vial of 2.5 ml in a box sealed with the cap on with lot number AR5186C, Expiry date: 17-Nov-2022 was administered past the manufacturer's expiration date. The vial had not undergone any temperature excursions.  No treatment medications were reported.
Breakthrough case admission after three vaccines; patient expired Moderna 1/16/21 Lot# 026L20A; Moderna 2/13/21 Lot# 007M2;  Moderna 10/27/21 Lot# 041C21A
Red itchy rash with center lump where the shot was given and spread to about7 inches around. very hot to touch. red ring lasted day 1, but itch and redness continued for 2 more days. used cortizone cream ( did not stop itch). finally controlled itch with benadyrl.
Severe pain under both ears, down neck for about 2 hours, then pain moved to rib cage.  Both lasted until about 2:30, then just stopped.  Rested lying down most of the time.  Called doctor about 10 am.
Sore arm (not too bad) next day and for a week All over body itchiness (no visible rash)   Resolved with benadryl
Body hurting; Headache; Chills; Fever of 99.0 Fahrenheit; This is a spontaneous report from a contactable consumer (patient).  A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 19Jun2021 11:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient received BNT162B2 dose 1 on an unspecified date for  covid-19 immunisation and had no reaction. The patient experienced body hurting, headache, chills and fever of 99.0 Fahrenheit, all in Jun2021 after second dose. He is asking if he can take Advil/Tylenol. The patient underwent lab tests and procedures which included body temperature: 99.0 fahrenheit in Jun2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021738286 same reporter/drug/AE with different patient
This spontaneous report as received from healthcare professional refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 13-MAR-2015, the patient was administered improperly stored GARDASIL (lot # K00691 and expiry date: 02-FEB-2017). No adverse effects were reported. The vaccine was stored as 48F for 58 hours. No product quality complaint (PQC) was reported GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse referring to an unknown number of patients of unknown age whom on an unknown date, were vaccinated with a dose of ZOSTAVAX (dose, route of administration and lot # not reported). The registered nurse reported that the patients may had been vaccinated with ZOSTAVAX stored at a higher than recommended temperature. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, an unspecified number of patients were vaccinated with doses of M-M-R II, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not provided), which were improperly stored (Incorrect product storage). No adverse effects were reported. Additional information has been requested.
Approx 1 month p/immun onset of sx of sore throat, leg pain, fatigue, stiffness, low grade temp, subsequently x 2 mo, arthralgias, stiffness, achiness; Seen on 3 occasions & rheumatologist treatment has been w/anti-inflammatory agents;
Fell on floor landed on butt Couldn't get up Was still sitting on floor and fell over on my face All within 2 min
Also c/o tingling in hands and feet; dizziness; This is a spontaneous report from a non-contactable other HCP. This other HCP reported for a 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) Intramuscular on 18Dec2020 at single dose in Right arm for covid-19 immunization. Medical history and concomitant drug were not reported. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minutes waiting period after the injection, the patient began to experience dizziness. Also c/o tingling in hands and feet. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, itching and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Treatment included water, granola bar, and rest. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
On 11/28/00 this student complained of soreness of the right deltoid, after school and in the evening. The next morning he had a sore arm and aching back. No fever, no meds. Returned to school 11/30/00.
Pt presented to ED 10/11 w/ c/o SOB & hypoxia; reports dx w/ COVID-19 7 days prior to presentation; pt admitted for acute resp failure w/ hypoxia & COVID-19 PNA; 10/11 - tx w/ decadron, levaquin; 10/12 - added Vit C, zithromax, rocephin, Vit D3, Protonix, Zinc; originally required 3L O2 but weaned to RA prior to discharge.
Product: TWINRIX -Hepatitis A & B recombinant vaccine- 1mL prefilled syringe Manufacturer: GlaxoSmithKline NDC: 58160-815-52 Lot: AHABB260AB Expiration date: 11/14/14 Nurse was preparing syringe for injection and noticed a white particle floating in 1 of 10 syringes. Initially, it was thought to be undissolved portion of suspension, however after vigorous shaking, suspension was uniformly dispersed throughout & particle remained. Prior to event, product was kept refrigerated at the appropriate temperature. The identified syringe was not used, and the remaining syringe from this package were sequestered. One syringe out of package was administered to a patient prior to this event.
Mom reports he did fine the rest of the day after vaccine, no fever or syncope. He got up the next day, ate breakfast and went outdoors to ride his bike. He rode his bike around the neighborhood for awhile and then "felt like my eyes needed to close" and the next thing he knew a neighbor was shaking him awake. He had apparently fainted, unable to describe much of a prodrome. Unknown how long he was "out" but likely seconds to a minute. Hit his head (not wearing a helmet)and scraped up his left side. Some residual confusion after (rang doorbell at his own home) but was fine in the days after. Mom did not report event to our office until several weeks later.
Flu: Initial information was received on 29-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media (under reference number: US-SA-SAC20211103000877).  This case involves a patient of (unknown demographics) who experienced flu (influenza) 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 flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I have not had one since I was a child. The same year I got the flu. I haven't had the flu many times in my life so I will just boost my immune system up with clean foods, water and supplements to heal my gut."  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the outcome was unknown for the event (influenza).  There will be no information available on the batch number for this case.
Pt recv vax on 10/6/98; 1 hr later pt exp soreness of Rt arm, difficulty moving arm, ecchymosis of Rt arm
Information has been received from a 30 year old female patient with papilloma viral infection, who on 24-JAN-2009 was vaccinated with a 0.5 mL dose of GARDASIL. There was no concomitant medication. On approximately 24-JAN-2009 the patient experienced tightness in her fingers and itching at the injection site. Sometimes it was hard for her to breath. It was difficult for the patient to walk and her body was feeling different. No laboratories studies performed. The patient sought unspecified medical attention. The patient has not recovered. Additional information has been requested.
pt recv vax & w/in 1-2wk of vax pt was exposed to wild type varicella virus;1DEC96 pt devel pinpoint rash similar to viral exanthem & exp t105;pt taken to ER & hosp for septic w/u;
Shortly after receiving second dose had a slight metallic taste in my mouth.   Today it's 6 days later and I still have it off and on.; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient (no pregnant) received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283) , via an unspecified route of administration on 01Feb2021 09:30 at single dose at left arm for covid-19 immunisation. The patient previously took the first dose bnt162b2 on 11Jan2021 for covid-19 immunization. The patient medical history was not reported. Concomitant medication included sertraline.  The patient experienced shortly after receiving second dose had a slight metallic taste in mouth on 01Feb2021 10:00. On 06Feb2021, it's 6 days later and patient still have it off and on.  No treatment for event. The outcome of event was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.
Patient given HPV vaccine and within a few seconds had a syncope episode. Vital signs taken, O2 per nasal cannula and Benadryl 25mg IM given. Patient recovered, discharged home with mother 1 hour later.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 3:05 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 3:38 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 60.66 for dose administered on 13-Feb-2021 and 60.76 for dose administered on 20-Mar-2021. No concomitant medications were reported.  Batch number 031A21A administered on 20-Mar-2021 underwent temperature excursion with temperature of 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021.  Batch number 031L20A administered on 13-Feb-2021 underwent temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Same as following the first two shots. Approximately 10 hours after the shot, patient was mentally confused and disorientated. She was not able to control her leg movement to perform a simple transfer from one chair to her wheelchair. Just as before after the first and second shot, she was much more alert and able to control her legs after about fours waiting time.
0953 - pt returned to room stating that she felt cold, dizzy, SOB (felt like she just exercised), weird feeling in mouth, light headed. VS 192/116, 97.5, 38, 98, 99% RA 0955 - called Rapid Response to come 0957 - VS 184/110, 83, 36 same symptoms, breathing feels like sh over-exerted exercising, feeling a little better, still has weird feeling in mouth 1000 - rapid response arrived. VS done BP still elevated, RN decided to take her to ER. Left @ 1003
pt recvd vax & w/in 24 hrs devel fever, abdo pain, diarrhea (lasting 2 wks), vomiting; pt felt not quite right for another wk;
received diluent only; received diluent only; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2021, the patient received Shingrix. On 30th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 30th September 2021, the outcome of the inappropriate preparation of medication was unknown. On an unknown date, the outcome of the inappropriate dose of vaccine administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient received only diluent portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No additional details were provided. The reported consented to follow up. This case was linked with the case US2021205510, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021205510:same reporter
Extreme fatigue began at 8pm on day of shot 8/03. Shortly followed by chills, headache, and a fever of 100°. By 2 am on 08/04  nausea and vomiting started. Nausea ceased by 8 am. Entire day of 08/04 fever remained between 99° and 100°. Arm pain at the site of the injection was very painful and stiff for 72 hours.  After 48 hours most other symptoms began  to decrease. General weakness continued for 4 days after the initial shot when strength began to return, but weakness in the left leg has continued to date.
Muscular weakness or myalgia; extended soreness after routine activity; delayed recovery after physical therapy. Got worse after November 26th 2022. Referred to Neurologist.
Moderna COVID-19 Vaccine EUA Severe chills and myalgias began 7 hours after vaccine administration. 400mg ibuprofen helped alleviate chills. Myalgias persisted. The following morning (18 hours after administration) chills resumed, myalgias were still present, and elevated temp to 99.4 was noted. Took 400mg ibuprofen which helped with all symptoms. Fatigue and myalgias have continued, now still present at 30 hours after administration.
Intense headache the first night, splotchy rash and burning feeling from head-to-toes.
Information has been received from a physician concerning a 4 year old male patient (his nephew) who in approximately August 2008, was vaccinated with his second dose of VARIVAX (Oka/Merck) (Lot # unspecified).  Around 01-NOV-2008, the patient developed shingles.  The patient sought medical attention.  At the time of reporting (02-DEC-2008) the outcome of the patient was unknown.  This is one of several reports from the same source.  Additional information has been requested.
No adverse effects; a patient was administered her first dose of the three dose series of GARDASIL 9 (lot and expiration unknown) on 8/19/2013 and was administered her second dose of GARDASIL 9 (1602283  8/16/2021) late on 6/18/2019; This spontaneous report was received from a registered nurse referring to a currently 26-year-old female patient. The patient's concurrent conditions, pertinent medical history, concomitant therapies and drug reactions/allergies were not reported.   On 19-AUG-2013, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency and route of administration not reported; lot # and expiration date unknown) as prophylaxis. Late on 18-JUN-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1602283, expiration date reported as 16-AUG-2021, but upon internal validation established as 18-AUG-2021) (dose, frequency and route of administration not reported) as prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
Lightheaded  Narrative:  apple juice given, pt states he is back to normal. No lightheadedness, dizziness, or sweaty. Pt states he believes it was low blood sugar. Pt felt better after drinking apple juice, VSS when pt left. BP 102/60, HR 100, T 97.9F, 97% RA
neck pain, glands swollen under jaw, rib pain and arm pain all on the side of the injection. She states that her mother had an adverse reaction several years ago that was similar but she couldn't move her arm for approx a month.
Child recieved shots at health department- behind schedule.Received 6 vaccines. Around 8 hours later, dad found child having seizure, limp, blue, drooling. Rushed to ER. Pediatricians feels child had febrile seizure. At home 3/17/09 and follow up with MD 3/17/09. Mom says chil received 2 doses of Motrin during the time period and did not seem to have fever. Mother believes child nearly died.  4/14/09 Received ER medical records of 3/16/2009. FINAL DX: new onset first time seizure Records reveal patient experienced found by parent slumping over when sitting in bed, shaking, turned blue then limp & unresponsive for few minutes.  In ER afebrile & back to normal behavior.  D/C to home, no meds, w/PCP f/u.
Headache, Myalgia, Arthralgia, Fever, left axillary lymph node swelling Narrative:
Mom reports badly developed rash 9/17/03 after injection.  rash started on facial rear and moved down the body.   Brought to health clinic on 4:30 9/19 with rash on face, arm , legs, refered to PMD
Vaccine was reported 02-Sep-2021 which was administered to patient on 22-SEP-2021; No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was reported 02-Sep-2021 which was administered to patient on 22-SEP-2021) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine  was reported 02-Sep-2021 which was administered to patient on 22-SEP-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was reported 02-Sep-2021 which was administered to patient on 22-SEP-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine was reported 02-Sep-2021 which was administered to patient on 22-SEP-2021).    No concomitant medication was reported.    No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow up received included narrative information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416: case