chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An event of expired vaccine administered occurred in a 49-year-old female. The report was received from a registered nurse. No medical or drug history information has been reported for this patient. The patient received a 1.05 ml dose of FLUMIST intranasally on 08-Oct-2007. On 08-Oct-2007 the reporter indicated a patient was inadvertently administered FLUMIST that had expired in Feb-2007. The reporter indicated the package was clearly labeled. The expired FLUMIST had been kept in the freezer in order to compare it with new vials received this season for changes. The error was discovered approximately 10 minutes after administering the dose. The reporter considered the patient about 20 minutes after dosing and the patient stated she was fine. No adverse events were observed. Outcome: the patient had no ill effects. Further dosing with FLUMIST is not indicated. The reporter did not provide a causality assessment for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Pt developed hives approximately 20 minutes post vax, accompanied by swelling. Treated with Benadryl.
Noted pain and swelling in arm next morning L arm 60x65mm swelling in muscle (skin above minor erythema only).
Tiredness, more then 24 hours later started with nausea and repeated vomiting, with diarrhea, fever 99, sweating, lethargic and shaking. All symptoms hit me all at once and all faded all at once.   I had covid in mid April 2020. I had the same symptoms as the with the covid except drawn out.
Rash on arm and elbow; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on arm and elbow) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concomitant products included TRAZODONE, CITALOPRAM, METOPROLOL and PRAVASTATIN for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced RASH (Rash on arm and elbow). At the time of the report, RASH (Rash on arm and elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication information was reported. Reporter stated that the patient has a history of right side stroke including the right hand. Hence the vaccine was administered on his right arm that way he could still use the left hand which was not affected by the stroke.
Onset urticaria upper body and arm vaccine given in. Benadryl 50 mg given IM @ 12:25PM and Pt told to contact FMD. She reported she went home, went to sleep and woke up with urticaria gone.  Prone to hives.
New onset altered mental status after fall. Per son, she was found in bed, unresponsive at around 12:15 AM on 1/10 by her husband. Brought to the emergency room and admitted,  Began treatment for UTI w/ CTX. Discharged 1/11/21 with f/u appointments
Within 2 weeks of second Pfizer vaccination  developed tinnitus both ears. At time did not connect this sudden event with the vaccine.  Was told no way to know cause and no treatment.
A day after taking the vaccine, my son suddenly stopped reacting, after receiving good medication at the health room. The street described it as a seizure. He was unresponsive for 30 seconds, and his head tilted. They laid him down. After he came back he was very tired and was taken to the hospital for exams.   I received this report from staff. It's the first time we know that he had a seizure.
Redness, high temperature (hot) in the vaccine area, swelling, pain and tenderness in the vaccine area, deep exhaustion, headache.
on day 7 after receiving first covid dose, she developed redness, swelling, and itching at injection site which lasted for 3 days and then resolved without any medical intervention.
Fever, fatigue, lymph node swelling, body aches, headache, sore throat, chills, muscle and joint pain, nausea, slight breathing difficulty,     Still have chills - shaking while sleeping,  fatigue, body aches.
administration / less than recommended dose due to leaking needle; administration / less than recommended dose due to leaking needle; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd June 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 23rd June 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete dose administered and syringe leak. On an unknown date, the outcome of the incomplete dose administered and syringe leak were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient administered Bexsero vaccine less than recommended dose due to leaking syringe, which led to incomplete dose administered and syringe leak. The reporter stated that, the exact date of administration was unknown, reported as 2 weeks ago.  No additional information regarding lot number or expiration date or patient demographics was known by the health care professional  at the time of reporting. The reporter consented to follow up.
Breakthrough COVID-19 infection. Patient received Moderna on 1/14/2021 and 2/11/2021.
L Sciatic Mononeuropathy 1 day after L deltoid injection standard flu vaccines at health center.
Pt recv vax on unknown day;  on 8/14/98 pt exp "more intense than the norm" vax site rxn
This spontaneous report as received from a registered nurse refers to patient of unknown age and gender. On 09-DEC-2013, the patient inadvertently vaccinated with a dose of VARIVAX (Merck) (VIAL 1350 U (lot #, expire date and indication not reported), 0.5 ml, subcutaneous) instead of ZOSTAVAX. The reporter stated that this was staff error and not related to product confusion. No adverse effect reported. It was unspecified whether the patient sought medical attention or not. Additional information has been requested.
Soreness, body aches & pains, fever, vomit, diarrhea, chills & uncontrollable shivers/shakes.  In it's 5th day and slowly recovering/feel slightly better.
Hives - Called Emergency Room - advised to take Benadryl.  Followed advice.  Hives went away but returned AM 10/29/2014.  Called hospital advised to take Benadryl for 2 days.  Outcome not known at this time.  Had never had a reaction before after many years of getting the flu shot.
Severe anxiety attack; difficulty breathing; hands drew up and contorted; mouth drew up - couldn't speak well; heart raced; numbness in extremities; husband took to emergency room; Dr. treated with anti-anxiety medication; gave prescription for lorazepam - 1mg.
Onset of ocular, face, and scalp involved shingles 5 days post vaccine.  Started with vomiting, dizziness, and nausea with sharp headache sinus pain on left side for four days.  Shingles rash appeared on Tuesday. Emergency care sought Wednesday.  Prescribed Vaktrax, steroid and antibiotic eye drops, and antibiotic gel for eye.  Seems to be improving slowly.  Will continue follow-up treatment to try to avoid eye complications.
Allergic reaction; Contraindicated drug administered; This case was reported by a consumer via interactive digital media and described the occurrence of documented hypersensitivity to administered product in a patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   Concurrent medical conditions included allergy to vaccine.   On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced documented hypersensitivity to administered product and contraindicated drug administered. On an unknown date, the outcome of the documented hypersensitivity to administered product and contraindicated drug administered were unknown.   It was unknown if the reporter considered the documented hypersensitivity to administered product and contraindicated drug administered to be related to dTpa vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient was allergic to the tetanus component of this vaccine. The patient got the DTP. The patient inquired, any other information available on that? This is 1 of 2 cases, reported by the same reporter.
I had a stroke on the right side of my brain on  June  16,  2021.   My  vaccine dates were   4/7/2021   &   4/28/ 2021.  i WAS taken to  first Hospital and second Hospital in after my stroke.   The  Hospitalisist doctors at first Hospital  are inefficient and irresponsible.   Avoid them !.
vertigo, her whole head was spinning all day with room spinning around her; super tired and fatigue; arm was sore and bruised; arm was sore and bruised; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONTUSION (arm was sore and bruised), VERTIGO (vertigo, her whole head was spinning all day with room spinning around her), PAIN IN EXTREMITY (arm was sore and bruised) and FATIGUE (super tired and fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE, PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), METHADONE, METFORMIN and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 08-Apr-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced CONTUSION (arm was sore and bruised) and PAIN IN EXTREMITY (arm was sore and bruised). On 10-Apr-2021, the patient experienced FATIGUE (super tired and fatigue). On 11-Apr-2021, the patient experienced VERTIGO (vertigo, her whole head was spinning all day with room spinning around her). On 11-Apr-2021, CONTUSION (arm was sore and bruised) and PAIN IN EXTREMITY (arm was sore and bruised) had resolved. At the time of the report, VERTIGO (vertigo, her whole head was spinning all day with room spinning around her) and FATIGUE (super tired and fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
A few minutes after vaccine administered, shortness of breath and weakness started. Because of my ALS, I have spasms at night. I also had involuntary contractions (spasms) in arms (forearms moved repeatedly and violently). These never happen during the day like this but can at night. Between contractions and early in the event,DR took vitals. Blood pressure 160/96 (usually 100/60) and heart rate 102 (usually 60?s). I felt odd before the contractions started that I attribute to the elevated blood pressure and heart rate. Entire episode lasted 30 minutes (estimate).
doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Total 26 doses/vials were reported. Dates of administration of vaccine were 14 ,15 , 16 , 18 and 21-FEB-2022. The vials did not undergo any temperature excursions.
4 year old female came for school vaccines. Received those listed below without incident. Never had reactions to immunizations in past. Warm, red, area of Rt deltoid noted 9/17/02 at noon, becoming worse on 9/18/02. Pt was complete use of arm, says it hurts, but sleeps, plays as usual.
Sudden presentation of Ecoli bladder infection with numerous clotting and emergency catheterization.  Have not had prior UTIs that I am aware of.  Urologist doesn't see any possible correlation but I am now on a third round of antibiotics.  Three days after my second shot on 3/12/2021 bleeding again started so now am now back on antibiotics.
>120mm local rxn to rt arm w/edema/erythema to surrounding area;edema from wrist to shoulder on day two;reduced w/NSAIDS & ice; recovered fully
All my life I have always had normal, regular menstrual cycles. After receiving my covid-19 vaccinations, my periods became heavier, worse and absent. I am now 70 days late on my period, not pregnant, and nothing has changed except the covid vaccine. When I got my last period, in July, I had the worst pain in my legs, my joints, everywhere. This has never happened before the shot. I am not 70 days late!
Patient received 4 doses of Pfizer vaccine at inappropriate times.  Facility was not aware that patient had received  2 doses of the vaccine when the  screening form was filled out.  third dose was reported as the  first dose on the screening form   hence  the  4th dose was  given as the  second dose.  first dose01/05/2021 second dose 04/12/2021 third dose 10/22/2021 fourth dose 11/10/2021 .
Sleeplessness and irritability. Seizures 10 days prior; sleeplessness for several weeks prior and began within 24 hours. We are seeing a neurologist and osteopath to cleanse her system.
Client became dizzy, diaphoretic.  Client was escorted to a chair and fainted in the presence of two licensed nursing staff.  No fall or injury.  Cool compresses provided.  Water to drink, which she vomited x 1.  Reports not eating breakfast.  Refused Orange Juice or crackers. Stayed for approximately 20 minutes after event.  Recovered well.  Escorted to PMV by RN and mother.
This case was reported by a other health professional via sales rep and described the occurrence of passed out in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The clinic notified to the reporter that they recently gave the patient a dose of SHINGRIX and the patient experienced passing out. No further details were available.
On 12/29/04 received Pediarix IM Left Leg at approx. 10:15 am.  Mom states around 6pm child began getting red blotches on face. Continued to get more red and raised from face down entire trunk and arms and legs over next several days. Seen in ER on 1/4/05. Given Amoxil 250mg/5cc- 1 tsp BID X 10 days(for ear infection) and 1 tube Nystatin cream to apply 4Xdaily. Follow up with Dr. on 1/05.  1/05 to ER again.Given Benadryl 1/4 tsp every 6 hours, baby oil bath and rub down, continue nystatin and amoxil. To Dr. 1/06, referred to hospital to see pediatric specialist. Instructed to stop antibiotic, continue with other tx. 1/07 to ER rash continues to get worse, decreased appetite and mom noticed some bruising  on arms and states blueish coloring on fingers/hands. Public Health nurse recommends mom to take child to ER at hospital. Seen in ER. Given 15 mg p.o. and Benadryl 3/4 tsp p.o. Child continued with prelone and benadryl over next 4 days.  Mom phoned public health nurse on 1/15. States rash continues to get worse again. Instructed to call ER again.  Instructed to continue with Prelone. Talked with mom on 1/18. Rash is clearing, but child still on prelone. Mom will continue to follow up on how child is doing.  Dr. informed mom to bring child in again if out of prelone and continues to break out.  Will possibly have to run further testing, etc.
Shortly after receiving dose 2 of Moderna vaccine, I came down with Shingles. I was diagnosed and treated with antiviral meds from CVS minute clinic and followed up with my rheumatologist who called in a second round of anti viral and advised me to stop the Humira which treats my RA.  I have had nothing but problems and flares since the second dose.
Pt recvd vax on 24AUG92 & devel a sore arm @ the inject site; No further details were provided;
11:42am Feeling dizziness and faintish, nauseous. 11:46am Left stated feelng much better. B/P 103/59, HR 76, O2Sat 98%.
pt recv vax 27MAR97; fever since shot date 101R to 105 R talked w/RN;30MAR97 8PM fever spike 107.6R tepid bath stiff & hallucinations to ER 9PM MD f/u in 2 days;med APPA w/codeine, Ibuprofen, Amoxicillin x ear drops T>102.7R;
Weakness (Mar 5 evening), not able to stand / walk (March 6) ending up in slurring of voice /lethargic , high BP (morning Mar.7). Called 911 and moved to ER @ Hospital. CT Scan did not show stroke, EEG showed slowness in brain activity, MRI showed minor stroke left side of brain.  Low salt (124) at the time of admittance. Released from Hospital on Mar 10.
05/17/21 side effects included: Injection site pain, fever, chills, extreme fatigue, joint pain, fluctuated between headache & migraine,  and sore throat. 05/20/21- 05/22/21 adverse effects included: sensation of body inflammation and bloated like, continuation of fatigue, weakness, induced vertigo. Late this evening adverse symptoms increased to include: rash's on arms, chest, legs and torso. Red blotches on body, rash turned into hives all over body including throat and face, and swollen lips that spread to severe facial swollen face and eye. Labored breathing, thick saliva and difficulty swallowing. Feeling chest tightness and pain.
pt recv vax in lt arm & w/in 15hr lt arm inflamed, mildly swollen, sore to touch, could not raise arm above shoulder, muscle tenderness;
Papular rash with red base some vesicular with yellow, fluid fill, non tender, more severe localized rash at site of injection.
Lightheaded, dizzy, weak to the point of nearly "passing out" within 10 minutes of vaccine and lasting for hours after. Treated with elevated feet, rest, and juice and food to help with low blood sugar feeling.
Pt broke out with chickenpox after brother exposure. Pt vaccinated 7/2/1996.
Injection 08/14/2006 4:30 PM onset redness injection site right thigh 08/16/2006 (am approximately 10:00 am mom noticed). Patient complained of itching at site, feverish08/15/2006 (local reaction).  Evaluated 08/16/2006 and 08/17/2006, treated ATARAX, symptoms decreased at office visit 07/28/2006, symptom totally resolved by Tuesday 08/01/2006.
I received my vaccine on 4/27/21. On 5/5/21, I woke up with a rash/hives on my left arm on the injection site. My arm feels sore and a bit numb.
Wednesday 3/31/21: Day of shot: Nausea - within 5-10 mins of injection  Thursday 4/21/21: Following day: Arm (right) pain, muscle pain, tired,  headache, fever of 99-100 degrees  To alleviate pain, took Vitamin C gummies (Equate brand) & Aleve
No adverse effect reported; improperly stored VARIVAX; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-SEP-2019, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) with lot # R019237, expiration date 04-JUL-2020 or lot# S005078, with expiration date 19-FEB-2021 , for prophylaxis (dose and route of administration were not reported) and was reconstituted with a properly stored sterile diluent(MERCK STERILE DILUENT).     The administered dose of the vaccine experienced a temperature excursion -14°C to -10°C (-9.74 C) degrees Celsius for an unknown time frame.   There was no adverse effect reported.  This call was because of a data logger and there were no previous temperature excursion.  No product quality complaint was involved.
Hives on inner forearm. Area cleaned, cold compress applied. Vitals wnl.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was Adult (18-64 Years). Other medication in 2weeks was reported as no.Patient was received Paxlovid as treatment. Treatment start date 31Jan2023. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day 1-3-headache, body pain, cold sweat, so took tylenol. Day 4-6- hard to walk and leg pain, take tylenol. Day 7-13- can walk but my leg and hand pains and shaking and headache feel like electric thru my head, take tylenol. Day 13-present- still have leg pain and headache like electric thru my head and my b ody shake itself when i move or stand little while
Extreme acid reflux. Feels like my throat is on fire. Nothing is helping to soothe it.
slight concentration issues; mild swelling similar to a histamine reaction; mild swelling similar to a histamine reaction; muscle tenderness; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 16Jan2021 11:00 at single dose in left arm for COVID-19 immunization. Medical history included mild allergies to pollens, insomnia, ongoing hypertension from years ago. Concomitant medications in two weeks included mirtazapine, ibuprofen. Facility type vaccine was Workplace clinic. No other vaccine in four weeks. On 18Jan2021 13:00, the patient experienced mild hypertension like symptoms, mild swelling similar to a histamine reaction, muscle tenderness, and slight concentration issues. No treatment received for the events. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovering.  Information about batch/lot number has been requested.
Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 01-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.